<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03041311</url>
  </required_header>
  <id_info>
    <org_study_id>G1T28-05</org_study_id>
    <secondary_id>2017-000358-20</secondary_id>
    <nct_id>NCT03041311</nct_id>
  </id_info>
  <brief_title>Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib (G1T28), a CDK4/6 Inhibitor, in Extensive-Stage SCLC</brief_title>
  <official_title>Phase 2 Study of Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib in Patients With Untreated Extensive-Stage Small Cell Lung Cancer (SCLC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>G1 Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Roche-Genentech</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>G1 Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This was a study to investigate the potential clinical benefit of trilaciclib (G1T28) in&#xD;
      preserving the bone marrow and the immune system, and enhancing antitumor efficacy when&#xD;
      administered with carboplatin, etoposide, and atezolizumab (E/P/A) therapy in first line&#xD;
      treatment for patients with newly diagnosed extensive-stage SCLC.&#xD;
&#xD;
      The study was a randomized, double-blinded, placebo-controlled design. Approximately, 100&#xD;
      patients were randomized to trilaciclib + E/P/A or placebo + E/P/A in the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The posted results represent the final results from Study G1T28-05, a Phase 2 study of&#xD;
      carboplatin, etoposide, and atezolizumab with or without trilaciclib (G1T28) in patients with&#xD;
      untreated extensive-stage small cell lung cancer (SCLC).&#xD;
&#xD;
      The final myelopreservation efficacy results are from database lock 1 (data cut-off [DCO] 17&#xD;
      Aug 2018). The final anti-tumor efficacy data (BOR, DOR, PFS) are from a second database lock&#xD;
      2 (DCO 28 June 2019) that occurred to support the trilaciclib New Drug Application (NDA).&#xD;
      Final overall survival and safety data are reported from the final study database lock (DCO&#xD;
      11 Dec 2020, last patient last visit date of 29 October 2020).&#xD;
&#xD;
      Please note the last patient last visit date description above which is recorded as the study&#xD;
      completion date. Following the last patient last visit, the final database lock occurred a&#xD;
      few weeks later which accounts for the discrepancy between the study completion date and the&#xD;
      reported assessment time frames.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Primary Analysis and survival follow up completed per protocol. Not stopped due to safety&#xD;
    concerns.&#xD;
  </why_stopped>
  <start_date type="Actual">June 29, 2017</start_date>
  <completion_date type="Actual">October 29, 2020</completion_date>
  <primary_completion_date type="Actual">August 17, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of Severe (Grade 4) Neutropenia in Cycle 1</measure>
    <time_frame>Evaluated for Cycle 1 of the Induction Period (i.e., from randomization to the end of Cycle 1, each cycle = 21 days).</time_frame>
    <description>Duration of severe neutropenia (DSN; days) was defined as the number of days from the date of the first absolute neutrophil count (ANC) value of &lt;0.5 × 10⁹/L observed between start of cycle and end of cycle to the date of the first ANC value ≥0.5 × 10⁹/L that met the following criteria: (1) occurred after the ANC value of &lt;0.5 × 10⁹/L and (2) no other ANC values &lt;0.5 × 10⁹/L occurred between this day and end of cycle. DSN was set to 0 for patients who did not experience severe neutropenia in a cycle, including those that were randomized and not treated. Data from unscheduled visits and the actual assessment date (rather than visit date) were included in the derivation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With at Least 1 Occurrence of Severe (Grade 4) Neutropenia</measure>
    <time_frame>Induction Period. From date of randomization, 21 day treatment cycles up to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.</time_frame>
    <description>The occurrence of severe (Grade 4) neutropenia (SN) was a binary variable. If a patient had at least 1 absolute neutrophil count value &lt;0.5 × 10^9/L during the Induction Period, the patient was assigned as Yes to the occurrence of SN; otherwise, it was No.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All-Cause Dose Reductions</measure>
    <time_frame>Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.</time_frame>
    <description>Dose reductions are not permitted for trilaciclib or atezolizumab. Dose reductions for E/P are derived from changes in the protocol-specified dose on the dosing page and correspond to the reductions for toxicity specified in the protocol. No more than 2 dose reductions of E/P in total were allowed for any patient. Simultaneous reduction in the doses of etoposide and carboplatin were counted as 1 dose reduction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With at Least 1 Occurrence of RBC Transfusion on/After Week 5 (Proportion of Patients)</measure>
    <time_frame>Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 374 days.</time_frame>
    <description>For this endpoint, the occurrence during the Induction Period was defined as a binary variable (Yes or No); Yes, if total number of events ≥1 was observed, No for other scenarios. If a patient did not have an event, a value of 0 was assigned to that patient. Each red blood cell transfusion with a unique start date on/after Week 5 on study during the Induction was defined as a separate event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of Granulocyte Colony-Stimulating Factor (G-CSF) Administration (Proportion of Patients)</measure>
    <time_frame>Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.</time_frame>
    <description>For this endpoint, the occurrence during the Induction Period was defined as a binary variable (Yes or No); Yes, if total number of events ≥1 was observed, No for other scenarios. If a patient did not have an event, a value of 0 was assigned to that patient. Any G-CSF administration in a cycle during the Induction Period was defined as a separate event. A patient with at least 1 cycle with G-CSF administration during an induction cycle or the Induction Period was considered to have occurrence of G-CSF administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>From date of randomization to date of death due to any cause, assessed up to a maximum of 38.1 months.</time_frame>
    <description>Overall survival was calculated as the time (months) from date of randomization to the date of death due to any cause. Patients who did not die during the study were censored at the date last known to be alive. Patients lacking data beyond the date of randomization had their survival time censored at date of randomization. Overall survival was not censored if a patient received other anti-tumor treatments after the study drugs. Overall survival was calculated using the Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Adverse Hematologic Events (MAHE) (Composite Endpoint)</measure>
    <time_frame>Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.</time_frame>
    <description>The composite endpoint &quot;major adverse hematologic events&quot; (MAHE) included the following aspects of myelosuppression:&#xD;
All-cause hospitalizations - Each recorded preferred term (PT) with a unique start date was counted as an event.&#xD;
All-cause dose reductions - Dose reductions were permitted for E/P but not for trilaciclib or atezolizumab. No more than 2 dose reductions were allowed. Each dose reduction was counted as a separate event.&#xD;
Febrile neutropenia-Each febrile neutropenia event with a unique start date during the Induction Period was defined as a separate event.&#xD;
Prolonged severe neutropenia (SN)-Each cycle with a severe neutropenia duration greater than 5 days was counted as an event, with the date of the first Grade 4 laboratory value defined as the start date for the time-to-first event analysis.&#xD;
Red blood cell (RBC) transfusion on/after Week 5-Each RBC transfusion with a unique start date on/after Week 5 on study during the Induction Period was defined as a separate event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best Overall Response</measure>
    <time_frame>From date of randomization, up to four 21-day cycles of Induction therapy, followed by 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 724 days.</time_frame>
    <description>For all patients, the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) tumor response data were used to determine each patient's visit response (TPR = time point response). Per RECIST v1.1 for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameters of target lesions; Progressive Disease (PD), &gt;=20% increase in the sum of the longest diameter of target lesions, Stable Disease, neither sufficient shrinkage or increase to quality for PR or PD. Objective Response Rate (ORR) = CR + PR. The TPR at each visit was determined in 2 ways: (1) derived programmatically at the time of analysis using the information from target lesions, non-target lesions, and new lesions based on data collected through eCRF; and (2) judged by the investigator as collected in the eCRF. Results shown here are from the programmatically derived assessments.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Objective Response (Complete Response or Partial Response)</measure>
    <time_frame>From date of randomization, up to four 21-day cycles of Induction therapy, followed by 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 724 days.</time_frame>
    <description>Duration of Response (DOR) is the time between first response by RECIST Version 1.1 of CR or PR and the first date that progressive disease is documented by RECIST Version 1.1, or death. Patients who do not experience PD or death will be censored at the last tumor assessment date. Only those patients with confirmed responses will be included in this analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival</measure>
    <time_frame>From date of randomization, up to four 21-day cycles of Induction therapy, followed by 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 724 days.</time_frame>
    <description>Progression-free survival (PFS) was defined as the time (number of months) from date of randomization until date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever came first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With at Least 1 Occurrence of Febrile Neutropenia</measure>
    <time_frame>Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.</time_frame>
    <description>The criterion for identifying febrile neutropenia was if the preferred term for an adverse event was &quot;FEBRILE NEUTROPENIA.&quot; Any occurrence of a febrile neutropenia event during the induction treatment period is defined as a binary variable (Yes or No); Yes if total number of febrile neutropenia events ≥ 1 is observed, No for other scenarios. Each febrile neutropenia event with a unique start date during the induction treatment period was defined as a separate event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With at Least 1 Occurrence of Grade 3 or 4 Hematologic Laboratory Abnormalities</measure>
    <time_frame>Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.</time_frame>
    <description>The occurrence of Grade 3 and 4 hematologic toxicities was a binary endpoint. If a patient had at least 1 cycle with at least 1 Grade 3 or 4 hematologic toxicities during the Induction Period, the patient was assigned as &quot;Yes&quot; to the occurrence of Grade 3 and 4 hematologic toxicities; otherwise, it was &quot;No&quot;. If a patient did not have an event, the value of 0 was assigned to that patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With at Least 1 Occurrence of Erythropoiesis Stimulating Agent (ESA) Administration</measure>
    <time_frame>Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.</time_frame>
    <description>Any ESA administration in a cycle during the Induction Period was defined as a separate event. A patient with at least 1 cycle with ESA administration during an induction cycle or the Induction Period was considered to have occurrence of ESA administration. The criterion to select proper records was as follows: If the chemical subgroup from WHO-DD Version September 2017 (ie TEXT4 for CODE4) takes the value &quot;OTHER ANTIANEMIC PREPARATIONS,&quot; the medication was classified as ESAs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With at Least 1 Occurrence of Platelet Transfusion</measure>
    <time_frame>Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.</time_frame>
    <description>Any occurrence of a platelet transfusion during the induction treatment period was defined as a binary variable (Yes or No); Yes if total number of febrile neutropenia events ≥ 1 is observed, No for other scenarios. If the patient did not have an event, the value of 0 was assigned to that patient. Each platelet transfusion event with a unique start date during the induction treatment period was defined as a separate event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With at Least 1 Occurrence of Infection Serious Adverse Events (SAEs)</measure>
    <time_frame>Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.</time_frame>
    <description>Any occurrence of an infection SAE during the induction treatment period was defined as a binary variable (Yes or No); Yes if total number of febrile neutropenia events ≥ 1 is observed, No for other scenarios. If the patient did not have an event, the value of 0 was assigned to that patient. The criterion for identifying the proper infection SAE records was as follows: if the system organ class (SOC) from Medical Dictionary for Regulatory Activities (MedDRA) Version 20.1 takes value &quot;INFECTIONS AND INFESTATIONS,&quot; and the AE was a serious event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With at Least 1 Occurrence of Pulmonary Infection Serious Adverse Events (SAEs)</measure>
    <time_frame>Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.</time_frame>
    <description>Any occurrence of a pulmonary SAE during the induction treatment period was defined as a binary variable (Yes or No); Yes if total number of febrile neutropenia events ≥ 1 is observed, No for other scenarios. If the patient did not have an event, the value of 0 was assigned to that patient. Each pulmonary infection SAE with a unique start date during the induction treatment period was defined as separate event. The criterion for identifying the proper pulmonary infection SAE records was as follows:&#xD;
The SOC from MedDRA Version 20.1 took the value &quot;INFECTIONS AND INFESTATIONS,&quot; the adverse event was a serious event, and the PT took values from the following list of PTs under the category of pulmonary infection adverse events: bronchiolitis, bronchitis, infectious pleural effusion, influenza, pneumonia, pneumonia bacterial, respiratory tract infection, upper respiratory tract infection, and viral upper respiratory tract infection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With at Least 1 Occurrence of IV Antibiotic Uses</measure>
    <time_frame>Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.</time_frame>
    <description>Occurrence of an IV antibiotics administration during the induction treatment period is defined as a binary variable (Yes or No); Yes if total number of IV antibiotics administration ≥ 1 is observed, No for other scenarios. Each IV antibiotic with a unique start date during the induction treatment period will be defined as a separate event. The criteria for identifying an IV antibiotic administration event was (1) if the therapeutic subgroup from WHO-DD Version September 2017 (ie, TEXT2 for CODE2) takes the value &quot;ANTIBACTERIALS FOR SYSTEMIC USE,&quot; and (2) the route of medication was &quot;intravenous&quot; or the route was &quot;other&quot; with the detailed specification as &quot;IVPB.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Study Drug Exposure (Induction Period and Maintenance Period)</measure>
    <time_frame>From date of first dose, up to four 21-day cycles of Induction therapy, followed by 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 1162 days.</time_frame>
    <description>Induction period duration of exposure (days) = Day 1 of last induction cycle - Cycle 1 Day 1 of induction phase + 21. Maintenance period duration of exposure (days) = Day 1 of the last maintenance cycle -Cycle 1 Day 1 of maintenance phase + 21.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Cycles Completed (Induction Period and Maintenance Period)</measure>
    <time_frame>From date of first dose, up to four 21-day cycles of Induction therapy, followed by 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 49 cycles.</time_frame>
    <description>Patients were considered to have started a cycle if they have received at least one dose of any study drug (carboplatin, etoposide, atezolizumab or trilaciclib).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative Dose Intensity of Trilaciclib/Placebo, Carboplatin, Etoposide, Atezolizumab (Induction Period) and Atezolizumab (Maintenance Period)</measure>
    <time_frame>From date of first dose, up to four 21-day cycles of Induction therapy, followed by 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 724 days.</time_frame>
    <description>Relative dose intensity is defined as 100% times the actual dose intensity divided by the planned dose intensity. The planned dose intensity is defined as the cumulative planned dose through the study divided by (number of cycles * 3 weeks)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Any Cycle Delays and the Number of Cycles Delayed (Induction Period)</measure>
    <time_frame>Induction Period. From date of first dose, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.</time_frame>
    <description>After Cycle 1, patients need to meet pre-specified laboratory parameter criteria before initiating Cycle 2 and each subsequent cycle of chemotherapy. A &quot;Cycle Day Status&quot; page asks if the cycle was delayed. If the start of the current cycle was delayed (the site answers &quot;Yes&quot;), this will be counted as a delay. Cycle delays could occur for management of toxicity (hematologic or non-hematologic) or for administrative/logistic reasons. The reason for each cycle delay was captured in the eCRF if it was related to AEs. Reasons other than AEs were not captured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Any Cycle Delays and the Number of Cycles Delayed (Maintenance Period)</measure>
    <time_frame>Maintenance Period. From date of first maintenance dose, 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 1160 days.</time_frame>
    <description>After Cycle 1, patients need to meet pre-specified laboratory parameter criteria before initiating Cycle 2 and each subsequent cycle of chemotherapy. A &quot;Cycle Day Status&quot; page asks if the cycle was delayed. If the start of the current cycle was delayed (the site answers &quot;Yes&quot;), this will be counted as a delay. Cycle delays could occur for management of toxicity (hematologic or non-hematologic) or for administrative/logistic reasons. The reason for each cycle delay was captured in the eCRF if it was related to AEs. Reasons other than AEs were not captured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Any Missed Doses [for Each Study Drug: Trilaciclib/Placebo, Carboplatin and Etoposide] (Induction Period)</measure>
    <time_frame>Induction Period. From date of first dose, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.</time_frame>
    <description>Missed doses are identified on the dosing page of each study drug based on the question &quot;Was the dose given?&quot;. The missed dose information will be obtained for each study drug. For a study drug, if the last record of response to question &quot;Was the dose given?&quot; is No, it will not be considered as a missed dose but instead considered to be end of treatment if both criteria below are met: (1) No other study drugs are given on the same day, and (2) No study drugs are given subsequently.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Any Missed Doses of Atezolizumab (Overall Treatment Period)</measure>
    <time_frame>From date of first dose, up to four 21-day cycles of Induction therapy, followed by 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 1162 days.</time_frame>
    <description>Missed doses are identified on the dosing page of each study drug based on the question &quot;Was the dose given?&quot;. The missed dose information will be obtained for each study drug. For a study drug, if the last record of response to question &quot;Was the dose given?&quot; is No, it will not be considered as a missed dose but instead considered to be end of treatment if both criteria below are met: (1) No other study drugs are given on the same day, and (2) No study drugs are given subsequently.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Any Dose Interruptions [for Each Study Drug: Trilaciclib/Placebo, Carboplatin and Etoposide] (Induction Period)</measure>
    <time_frame>Induction Period. From date of first dose, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.</time_frame>
    <description>Dose interruptions were defined as interruption of infusion, regardless of whether the study drug was continued after the interruption.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Any Interrupted Doses of Atezolizumab (Overall Treatment Period)</measure>
    <time_frame>From date of first dose, up to four 21-day cycles of Induction therapy, followed by 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 1162 days.</time_frame>
    <description>Dose interruptions were defined as interruption of infusion, regardless of whether the study drug was continued after the interruption.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Any Dose Reductions of Carboplatin and Etoposide (Induction Period)</measure>
    <time_frame>Induction Period. From date of first dose, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.</time_frame>
    <description>No dose reductions were allowed for trilaciclib or atezolizumab during the study.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">107</enrollment>
  <condition>Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>trilaciclib+etoposide/carboplatin/atezolizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Induction: Patients received trilaciclib 240 mg/m² administered intravenously (IV) once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target area under the concentration-time curve (AUC) = 5 milligrams per milliliter per minute (mg/mL/min) to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or discontinuation by the patient or investigator.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo+etoposide/carboplatin/atezolizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was be administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or discontinuation by the patient or investigator.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trilaciclib</intervention_name>
    <description>Trilaciclib IV</description>
    <arm_group_label>trilaciclib+etoposide/carboplatin/atezolizumab</arm_group_label>
    <other_name>G1T28</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo IV</description>
    <arm_group_label>placebo+etoposide/carboplatin/atezolizumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>Carboplatin IV</description>
    <arm_group_label>placebo+etoposide/carboplatin/atezolizumab</arm_group_label>
    <arm_group_label>trilaciclib+etoposide/carboplatin/atezolizumab</arm_group_label>
    <other_name>Paraplatin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etoposide</intervention_name>
    <description>Etoposide IV</description>
    <arm_group_label>placebo+etoposide/carboplatin/atezolizumab</arm_group_label>
    <arm_group_label>trilaciclib+etoposide/carboplatin/atezolizumab</arm_group_label>
    <other_name>VP-16</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atezolizumab</intervention_name>
    <description>Atezolizumab IV</description>
    <arm_group_label>placebo+etoposide/carboplatin/atezolizumab</arm_group_label>
    <arm_group_label>trilaciclib+etoposide/carboplatin/atezolizumab</arm_group_label>
    <other_name>Tecentriq</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Male or female subjects aged ≥18 years&#xD;
&#xD;
          -  Unequivocally confirmed diagnosis of SCLC by histology or cytology, preferably&#xD;
             including the presence of neuroendocrine features by immunohistochemistry&#xD;
&#xD;
          -  Extensive-stage SCLC&#xD;
&#xD;
          -  At least 1 target lesion that is measurable by Response Evaluation Criteria in Solid&#xD;
             Tumors (RECIST) Version 1.1&#xD;
&#xD;
          -  Adequate organ function&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2&#xD;
&#xD;
          -  Predicted life expectancy of ≥3 months&#xD;
&#xD;
          -  Able to understand and sign an informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Limited-stage SCLC&#xD;
&#xD;
          -  Prior chemotherapy for limited or extensive-stage SCLC&#xD;
&#xD;
          -  Prior treatment with immunotherapies including but not limited to cluster of&#xD;
             differentiation 137 agonists or immune checkpoint blockade therapies (such as&#xD;
             anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1(PD-L1),&#xD;
             and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) therapeutic antibodies).&#xD;
&#xD;
          -  Presence of symptomatic brain metastases requiring immediate treatment with radiation&#xD;
             therapy or steroids.&#xD;
&#xD;
          -  Malignancies other than SCLC within 3 years prior to randomization, with the exception&#xD;
             of those with negligible risk of metastasis or death treated with expected curative&#xD;
             outcome&#xD;
&#xD;
          -  History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced&#xD;
             pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening&#xD;
             chest CT scan&#xD;
&#xD;
          -  Active, known, suspected autoimmune disease requiring systemic treatment in the past 2&#xD;
             years&#xD;
&#xD;
          -  Uncontrolled ischemic heart disease or uncontrolled symptomatic congestive heart&#xD;
             failure&#xD;
&#xD;
          -  Known history of stroke or cerebrovascular accident within 6 months prior to&#xD;
             enrollment&#xD;
&#xD;
          -  Serious active infection at the time of enrollment&#xD;
&#xD;
          -  Psychiatric illness/social situations that would limit study compliance&#xD;
&#xD;
          -  Other uncontrolled serious chronic disease or conditions that in the investigator's&#xD;
             opinion could affect compliance or follow-up in the protocol&#xD;
&#xD;
          -  Known human immunodeficiency virus, known active hepatitis B, or hepatitis C&#xD;
&#xD;
          -  Radiotherapy to any site or radiotherapy within 2 weeks prior to enrollment&#xD;
&#xD;
          -  Receipt of any investigational medication within 4 weeks prior to enrollment&#xD;
&#xD;
          -  Administration of attenuated vaccine within 4 weeks before enrollment or anticipation&#xD;
             that such a live attenuated vaccine will be required during the study&#xD;
&#xD;
          -  Influenza vaccination should be given during influenza season only (approx. Oct to&#xD;
             March). Patients must not receive live, attenuated influenza vaccine (eg, FluMist)&#xD;
             within 4 weeks prior to enrollment at any time during the study, and at least 5 months&#xD;
             after the last dose of atezolizumab.&#xD;
&#xD;
          -  Patients with a condition requiring systemic treatment with either corticosteroids ( &gt;&#xD;
             10 mg daily prednisone equivalents) or other immunosuppressive medications (including&#xD;
             but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and&#xD;
             anti-tumor necrosis factor agents) within 14 days of study drug administration.&#xD;
             Inhaled or topical steroids ad adrenal replacement dosed &gt; 10 mg daily prednisone&#xD;
             equivalents are permitted in the absence of active autoimmune disease.&#xD;
&#xD;
          -  Hypersensitivity to any of the components of the formulation of etoposide or etoposide&#xD;
             phosphate&#xD;
&#xD;
          -  Hypersensitivity to carboplatin or other platinum-containing compounds or to mannitol&#xD;
&#xD;
          -  History of severe allergic, anaphylactic, or other hypersensitivity reactions to&#xD;
             chimeric or humanized antibodies or fusion proteins&#xD;
&#xD;
          -  Known hypersensitivity to Chinese hamster ovary cell products or other recombinant&#xD;
             human antibodies&#xD;
&#xD;
          -  Legal incapacity or limited legal capacity&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Contact</last_name>
    <role>Study Director</role>
    <affiliation>G1 Therapeutics, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beverly Hills Cancer Center</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Jude Heritage Healthcare</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loma Linda University</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92350</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Medical Center - Santa Monica Hematology And Oncology</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Redwood Regional Medical Group (RRMG) - Fountain Grove</name>
      <address>
        <city>Santa Rosa</city>
        <state>California</state>
        <zip>95403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Singing River Health System</name>
      <address>
        <city>Whittier</city>
        <state>California</state>
        <zip>90603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Cancer Institute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30318</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northside Hospital - Georgia Cancer Specialists</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30341</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Joliet Oncology-Hematology Associates</name>
      <address>
        <city>Joliet</city>
        <state>Illinois</state>
        <zip>60435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Horizon Oncology Center</name>
      <address>
        <city>Lafayette</city>
        <state>Indiana</state>
        <zip>47905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Clinic Foundation</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Louis Cancer Care, LLP, North County</name>
      <address>
        <city>Bridgeton</city>
        <state>Missouri</state>
        <zip>63044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Alvin J. Siteman Cancer Center - Center for Advanced Med</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110-1094</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Summit Medical Group, P.A.</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07962</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern Westchester Hospital</name>
      <address>
        <city>Mount Kisco</city>
        <state>New York</state>
        <zip>10549</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trinity Health - Trinity CancerCare Center</name>
      <address>
        <city>Minot</city>
        <state>North Dakota</state>
        <zip>58701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oklahoma University - Peggy and Charles Stephenson Cancer Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gibbs Cancer Center</name>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <zip>29303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Cancer Associates</name>
      <address>
        <city>Harlingen</city>
        <state>Texas</state>
        <zip>78550</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Millennium Oncology</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Cancer Specialists</name>
      <address>
        <city>Arlington</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Blue Ridge Cancer Care</name>
      <address>
        <city>Blacksburg</city>
        <state>Virginia</state>
        <zip>24060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fort Belvoir Community Hospital</name>
      <address>
        <city>Fort Belvoir</city>
        <state>Virginia</state>
        <zip>22060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complex Oncology Center - Burgas</name>
      <address>
        <city>Burgas</city>
        <zip>8000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multiprofile Hospital for Active Treatment &quot;Serdika&quot;, Sofia</name>
      <address>
        <city>Sofia</city>
        <zip>1303</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multiprofile Hospital for Active Treatment &quot;Serdika&quot;</name>
      <address>
        <city>Sofia</city>
        <zip>1303</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Tallinn Central Hospital Ltd., Clinic of Internal Medicine, Center for Oncology</name>
      <address>
        <city>Tallinn</city>
        <zip>11312</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Caen De La Côte De Nacre</name>
      <address>
        <city>Caen</city>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Oscar Lambret</name>
      <address>
        <city>Lille</city>
        <zip>59020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Daugavpils Regional Hospital, Department of Oncology</name>
      <address>
        <city>Daugavpils</city>
        <zip>LV-5417</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pauls Stradiņš Clinical University Hospital, Oncology Clinic</name>
      <address>
        <city>Riga</city>
        <zip>LV-1002</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Son Espases</name>
      <address>
        <city>Palma</city>
        <state>Islas Baleares</state>
        <zip>07120</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Teresa Herrera</name>
      <address>
        <city>A Coruña</city>
        <state>La Coruña</state>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Puerta de Hierro Majadahonda</name>
      <address>
        <city>Majadahonda</city>
        <state>Madrid</state>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico</name>
      <address>
        <city>San Carlos</city>
        <state>Madrid</state>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H.U. Quirón Dexeus, Hospital Universitario</name>
      <address>
        <city>Barcelona</city>
        <zip>08028</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic de Barcelona- Servicio de Oncología Médica</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H. Donostia, Hospital Donostia- Servicio de Oncología</name>
      <address>
        <city>San Sebastián</city>
        <zip>20014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ntra. Sra. de Valme</name>
      <address>
        <city>Sevilla</city>
        <zip>41014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Arnau de Vilanova</name>
      <address>
        <city>Valencia</city>
        <zip>46015</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chernivtsi Regional Clinical Oncology Center</name>
      <address>
        <city>Chernivtsi</city>
        <zip>58013</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dnipropetrovsk City Multispecialty Clinical Hospital #4</name>
      <address>
        <city>Dnipro</city>
        <zip>49102</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lviv State Regional Treatment and Diagnostics Oncology Center</name>
      <address>
        <city>Lviv</city>
        <zip>79031</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>Estonia</country>
    <country>France</country>
    <country>Latvia</country>
    <country>Spain</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Daniel D, Kuchava V, Bondarenko I, Ivashchuk O, Reddy S, Jaal J, Kudaba I, Hart L, Matitashvili A, Pritchett Y, Morris SR, Sorrentino JA, Antal JM, Goldschmidt J. Trilaciclib prior to chemotherapy and atezolizumab in patients with newly diagnosed extensive-stage small cell lung cancer: A multicentre, randomised, double-blind, placebo-controlled Phase II trial. Int J Cancer. 2020 Dec 21;148(10):2557-70. doi: 10.1002/ijc.33453. Online ahead of print.</citation>
    <PMID>33348420</PMID>
  </reference>
  <reference>
    <citation>Weiss J, Goldschmidt J, Andric Z, Dragnev KH, Gwaltney C, Skaltsa K, Pritchett Y, Antal JM, Morris SR, Daniel D. Effects of Trilaciclib on Chemotherapy-Induced Myelosuppression and Patient-Reported Outcomes in Patients with Extensive-Stage Small Cell Lung Cancer: Pooled Results from Three Phase II Randomized, Double-Blind, Placebo-Controlled Studies. Clin Lung Cancer. 2021 Sep;22(5):449-460. doi: 10.1016/j.cllc.2021.03.010. Epub 2021 Mar 26.</citation>
    <PMID>33895103</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <results_first_submitted>January 7, 2022</results_first_submitted>
  <results_first_submitted_qc>April 8, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">May 6, 2022</results_first_posted>
  <disposition_first_submitted>July 18, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>April 8, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">May 6, 2022</disposition_first_posted>
  <last_update_submitted>April 8, 2022</last_update_submitted>
  <last_update_submitted_qc>April 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Small Cell Lung Cancer</keyword>
  <keyword>CDK4/6 Inhibitor</keyword>
  <keyword>Immune Checkpoint Inhibitor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Small Cell Lung Carcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Etoposide</mesh_term>
    <mesh_term>Atezolizumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 14, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT03041311/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan: Region 2</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT03041311/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Trilaciclib+Etoposide/Carboplatin/Atezolizumab</title>
          <description>Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
        </group>
        <group group_id="P2">
          <title>Placebo+Etoposide/Carboplatin/Atezolizumab</title>
          <description>Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="54"/>
                <participants group_id="P2" count="53"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="54"/>
                <participants group_id="P2" count="53"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="42"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor Terminated Study</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Disease Progression</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized in error, did not receive drug</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Trilaciclib+Etoposide/Carboplatin/Atezolizumab</title>
          <description>Induction: Patients received trilaciclib 240 mg/m² administered IV once daily on Days prior to E/P/A 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
        </group>
        <group group_id="B2">
          <title>Placebo+Etoposide/Carboplatin/Atezolizumab</title>
          <description>Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or discontinuation by the patient or investigator.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="54"/>
            <count group_id="B2" value="53"/>
            <count group_id="B3" value="107"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63" spread="8.4"/>
                    <measurement group_id="B2" value="64" spread="8.3"/>
                    <measurement group_id="B3" value="64" spread="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Latvia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ukraine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bulgaria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Estonia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Georgia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Weight at Screening</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="79.2" spread="17.32"/>
                    <measurement group_id="B2" value="72.4" spread="14.42"/>
                    <measurement group_id="B3" value="75.8" spread="16.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height at Screening</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="171.1" spread="7.62"/>
                    <measurement group_id="B2" value="168.6" spread="10.21"/>
                    <measurement group_id="B3" value="169.9" spread="9.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI at Screening</title>
          <units>kg/m²</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.10" spread="5.907"/>
                    <measurement group_id="B2" value="25.45" spread="4.618"/>
                    <measurement group_id="B3" value="26.28" spread="5.347"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Surface Area (m²) at Screening</title>
          <units>m²</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.91" spread="0.198"/>
                    <measurement group_id="B2" value="1.82" spread="0.205"/>
                    <measurement group_id="B3" value="1.86" spread="0.205"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ECOG Performance Status</title>
          <description>The publicly available Easter Cooperative Oncology Group (ECOG) Performance Status Scale was utilized to assess patient level of functioning. Increasing numbers indicate worse outcomes.&#xD;
GRADE ECOG PERFORMANCE STATUS 0 Fully active, able to carry on all pre-disease performance without restriction&#xD;
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work&#xD;
Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>0-1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Duration of Severe (Grade 4) Neutropenia in Cycle 1</title>
        <description>Duration of severe neutropenia (DSN; days) was defined as the number of days from the date of the first absolute neutrophil count (ANC) value of &lt;0.5 × 10⁹/L observed between start of cycle and end of cycle to the date of the first ANC value ≥0.5 × 10⁹/L that met the following criteria: (1) occurred after the ANC value of &lt;0.5 × 10⁹/L and (2) no other ANC values &lt;0.5 × 10⁹/L occurred between this day and end of cycle. DSN was set to 0 for patients who did not experience severe neutropenia in a cycle, including those that were randomized and not treated. Data from unscheduled visits and the actual assessment date (rather than visit date) were included in the derivation.</description>
        <time_frame>Evaluated for Cycle 1 of the Induction Period (i.e., from randomization to the end of Cycle 1, each cycle = 21 days).</time_frame>
        <population>Intent-to-treat (ITT) analysis set included all randomized patients. Analysis using the ITT analysis set were conducted on the basis of the randomly assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Trilaciclib+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
          <group group_id="O2">
            <title>Placebo+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Severe (Grade 4) Neutropenia in Cycle 1</title>
          <description>Duration of severe neutropenia (DSN; days) was defined as the number of days from the date of the first absolute neutrophil count (ANC) value of &lt;0.5 × 10⁹/L observed between start of cycle and end of cycle to the date of the first ANC value ≥0.5 × 10⁹/L that met the following criteria: (1) occurred after the ANC value of &lt;0.5 × 10⁹/L and (2) no other ANC values &lt;0.5 × 10⁹/L occurred between this day and end of cycle. DSN was set to 0 for patients who did not experience severe neutropenia in a cycle, including those that were randomized and not treated. Data from unscheduled visits and the actual assessment date (rather than visit date) were included in the derivation.</description>
          <population>Intent-to-treat (ITT) analysis set included all randomized patients. Analysis using the ITT analysis set were conducted on the basis of the randomly assigned treatment.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="1.0"/>
                    <measurement group_id="O2" value="4" spread="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Treatment difference was evaluated using a nonparametric analysis of covariance (ANCOVA). The nonparametric ANCOVA included study baseline ANC value as covariate, stratification factors of ECOG performance status (0 to 1 versus 2) and brain metastases (Yes versus No), and treatment as a fixed effect.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (for 2 primary and 3 key secondary endpoints) in a strong sense at a 1-sided 0.025 level.</p_value_desc>
            <method>non-parametric ANCOVA</method>
            <method_desc>Hochberg-based gatekeeping procedure</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With at Least 1 Occurrence of Severe (Grade 4) Neutropenia</title>
        <description>The occurrence of severe (Grade 4) neutropenia (SN) was a binary variable. If a patient had at least 1 absolute neutrophil count value &lt;0.5 × 10^9/L during the Induction Period, the patient was assigned as Yes to the occurrence of SN; otherwise, it was No.</description>
        <time_frame>Induction Period. From date of randomization, 21 day treatment cycles up to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.</time_frame>
        <population>Intent-to-treat (ITT) analysis set included all randomized patients. Analysis using the ITT analysis set were conducted on the basis of the randomly assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Trilaciclib+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator</description>
          </group>
          <group group_id="O2">
            <title>Placebo+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was be administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With at Least 1 Occurrence of Severe (Grade 4) Neutropenia</title>
          <description>The occurrence of severe (Grade 4) neutropenia (SN) was a binary variable. If a patient had at least 1 absolute neutrophil count value &lt;0.5 × 10^9/L during the Induction Period, the patient was assigned as Yes to the occurrence of SN; otherwise, it was No.</description>
          <population>Intent-to-treat (ITT) analysis set included all randomized patients. Analysis using the ITT analysis set were conducted on the basis of the randomly assigned treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The occurrence of SN was a binary variable. Treatment group difference was analyzed using a modified Poisson regression model to account for the variable duration of the Induction Period for each patient. The model included baseline ANC count as a covariate, the stratification factors of ECOG performance status (0 to1 vs. 2) and brain metastases (Yes vs. No), and treatment as a fixed effect. The logarithm transformation of # of Induction cycles was included as an offset variable in the modeling.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (for 2 primary and 3 key secondary endpoints) in a strong sense at a 1-sided 0.025 level.</p_value_desc>
            <method>Modified Poisson</method>
            <method_desc>Hochberg-based gatekeeping procedure</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>All-Cause Dose Reductions</title>
        <description>Dose reductions are not permitted for trilaciclib or atezolizumab. Dose reductions for E/P are derived from changes in the protocol-specified dose on the dosing page and correspond to the reductions for toxicity specified in the protocol. No more than 2 dose reductions of E/P in total were allowed for any patient. Simultaneous reduction in the doses of etoposide and carboplatin were counted as 1 dose reduction.</description>
        <time_frame>Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.</time_frame>
        <population>Intent-to-treat (ITT) analysis set included all randomized patients. Analysis using the ITT analysis set were conducted on the basis of the randomly assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Trilaciclib+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator</description>
          </group>
          <group group_id="O2">
            <title>Placebo+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was be administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>All-Cause Dose Reductions</title>
          <description>Dose reductions are not permitted for trilaciclib or atezolizumab. Dose reductions for E/P are derived from changes in the protocol-specified dose on the dosing page and correspond to the reductions for toxicity specified in the protocol. No more than 2 dose reductions of E/P in total were allowed for any patient. Simultaneous reduction in the doses of etoposide and carboplatin were counted as 1 dose reduction.</description>
          <population>Intent-to-treat (ITT) analysis set included all randomized patients. Analysis using the ITT analysis set were conducted on the basis of the randomly assigned treatment.</population>
          <units>Events/Cycle</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.021"/>
                    <measurement group_id="O2" value="0.085"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0195</p_value>
            <p_value_desc>A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (for 2 primary and 3 key secondary endpoints) in a strong sense at a 1-sided 0.025 level.</p_value_desc>
            <method>negative binomial regression</method>
            <method_desc>Hochberg-based gatekeeping procedure</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With at Least 1 Occurrence of RBC Transfusion on/After Week 5 (Proportion of Patients)</title>
        <description>For this endpoint, the occurrence during the Induction Period was defined as a binary variable (Yes or No); Yes, if total number of events ≥1 was observed, No for other scenarios. If a patient did not have an event, a value of 0 was assigned to that patient. Each red blood cell transfusion with a unique start date on/after Week 5 on study during the Induction was defined as a separate event.</description>
        <time_frame>Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 374 days.</time_frame>
        <population>Intent-to-treat (ITT) analysis set included all randomized patients. Analysis using the ITT analysis set were conducted on the basis of the randomly assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Trilaciclib+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
          <group group_id="O2">
            <title>Placebo+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With at Least 1 Occurrence of RBC Transfusion on/After Week 5 (Proportion of Patients)</title>
          <description>For this endpoint, the occurrence during the Induction Period was defined as a binary variable (Yes or No); Yes, if total number of events ≥1 was observed, No for other scenarios. If a patient did not have an event, a value of 0 was assigned to that patient. Each red blood cell transfusion with a unique start date on/after Week 5 on study during the Induction was defined as a separate event.</description>
          <population>Intent-to-treat (ITT) analysis set included all randomized patients. Analysis using the ITT analysis set were conducted on the basis of the randomly assigned treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Treatment group difference was analyzed using a modified Poisson regression model. The model included baseline hemoglobin as a covariate, the stratification factors of ECOG performance status (0 to 1 versus 2) and brain metastases (Yes versus No) and treatment as a fixed effect. The logarithm transformation of the number of weeks on treatment was included as an offset variable in the model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1335</p_value>
            <p_value_desc>A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (for 2 primary and 3 key secondary endpoints) in a strong sense at a 1-sided 0.025 level.</p_value_desc>
            <method>Modified Poisson</method>
            <method_desc>Hochberg-based gatekeeping procedure</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Occurrence of Granulocyte Colony-Stimulating Factor (G-CSF) Administration (Proportion of Patients)</title>
        <description>For this endpoint, the occurrence during the Induction Period was defined as a binary variable (Yes or No); Yes, if total number of events ≥1 was observed, No for other scenarios. If a patient did not have an event, a value of 0 was assigned to that patient. Any G-CSF administration in a cycle during the Induction Period was defined as a separate event. A patient with at least 1 cycle with G-CSF administration during an induction cycle or the Induction Period was considered to have occurrence of G-CSF administration.</description>
        <time_frame>Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.</time_frame>
        <population>Intent-to-treat (ITT) analysis set included all randomized patients. Analysis using the ITT analysis set were conducted on the basis of the randomly assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Trilaciclib+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
          <group group_id="O2">
            <title>Placebo+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Occurrence of Granulocyte Colony-Stimulating Factor (G-CSF) Administration (Proportion of Patients)</title>
          <description>For this endpoint, the occurrence during the Induction Period was defined as a binary variable (Yes or No); Yes, if total number of events ≥1 was observed, No for other scenarios. If a patient did not have an event, a value of 0 was assigned to that patient. Any G-CSF administration in a cycle during the Induction Period was defined as a separate event. A patient with at least 1 cycle with G-CSF administration during an induction cycle or the Induction Period was considered to have occurrence of G-CSF administration.</description>
          <population>Intent-to-treat (ITT) analysis set included all randomized patients. Analysis using the ITT analysis set were conducted on the basis of the randomly assigned treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Treatment group difference was analyzed using a modified Poisson regression model to account for the variable duration of the Induction Period for each patient. The model included baseline absolute neutrophil count as a covariate, the stratification factors of ECOG performance status (0 to 1 versus 2) and brain metastases (Yes versus No), and treatment as a fixed effect. The logarithm transformation of number of Induction cycles was included as an offset variable in the modeling.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0686</p_value>
            <p_value_desc>A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (for 2 primary and 3 key secondary endpoints) in a strong sense at a 1-sided 0.025 level.</p_value_desc>
            <method>Modified Poisson</method>
            <method_desc>Hochberg-based gatekeeping procedure</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>Overall survival was calculated as the time (months) from date of randomization to the date of death due to any cause. Patients who did not die during the study were censored at the date last known to be alive. Patients lacking data beyond the date of randomization had their survival time censored at date of randomization. Overall survival was not censored if a patient received other anti-tumor treatments after the study drugs. Overall survival was calculated using the Kaplan-Meier method.</description>
        <time_frame>From date of randomization to date of death due to any cause, assessed up to a maximum of 38.1 months.</time_frame>
        <population>Intent-to-treat (ITT Analysis Set)</population>
        <group_list>
          <group group_id="O1">
            <title>Trilaciclib+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or discontinuation by the patient or investigator.</description>
          </group>
          <group group_id="O2">
            <title>Placebo+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or discontinuation by the patient or investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>Overall survival was calculated as the time (months) from date of randomization to the date of death due to any cause. Patients who did not die during the study were censored at the date last known to be alive. Patients lacking data beyond the date of randomization had their survival time censored at date of randomization. Overall survival was not censored if a patient received other anti-tumor treatments after the study drugs. Overall survival was calculated using the Kaplan-Meier method.</description>
          <population>Intent-to-treat (ITT Analysis Set)</population>
          <units>Months</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>25%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2" lower_limit="4.9" upper_limit="10.2"/>
                    <measurement group_id="O2" value="6.7" lower_limit="3.6" upper_limit="8.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Median</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0" lower_limit="9.6" upper_limit="16.2"/>
                    <measurement group_id="O2" value="12.8" lower_limit="7.9" upper_limit="15.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>75%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.6" lower_limit="14.5" upper_limit="23.2"/>
                    <measurement group_id="O2" value="22.4" lower_limit="15.5" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>For time-to-event variable, the Kaplan-Meier method was used to estimate its within group median value, 25% and 75% percentile values.</non_inferiority_desc>
            <p_value>0.9942</p_value>
            <p_value_desc>The 2-sided p-value was obtained from the stratified log-rank test to account for the stratification factors.</p_value_desc>
            <method>Log Rank</method>
            <method_desc>stratified log-rank test</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.99</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.218</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.64</ci_lower_limit>
            <ci_upper_limit>1.52</ci_upper_limit>
            <estimate_desc>The HR and its 95% CI were calculated using the Cox proportional hazard regression model with treatment and stratification factors of ECOG performance status (0 to 1 versus 2) and presence of brain metastases (Yes versus No).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Major Adverse Hematologic Events (MAHE) (Composite Endpoint)</title>
        <description>The composite endpoint &quot;major adverse hematologic events&quot; (MAHE) included the following aspects of myelosuppression:&#xD;
All-cause hospitalizations - Each recorded preferred term (PT) with a unique start date was counted as an event.&#xD;
All-cause dose reductions - Dose reductions were permitted for E/P but not for trilaciclib or atezolizumab. No more than 2 dose reductions were allowed. Each dose reduction was counted as a separate event.&#xD;
Febrile neutropenia-Each febrile neutropenia event with a unique start date during the Induction Period was defined as a separate event.&#xD;
Prolonged severe neutropenia (SN)-Each cycle with a severe neutropenia duration greater than 5 days was counted as an event, with the date of the first Grade 4 laboratory value defined as the start date for the time-to-first event analysis.&#xD;
Red blood cell (RBC) transfusion on/after Week 5-Each RBC transfusion with a unique start date on/after Week 5 on study during the Induction Period was defined as a separate event.</description>
        <time_frame>Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.</time_frame>
        <population>Intent-to-treat (ITT) analysis set included all randomized patients. Analysis using the ITT analysis set were conducted on the basis of the randomly assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Trilaciclib+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
          <group group_id="O2">
            <title>Placebo+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Major Adverse Hematologic Events (MAHE) (Composite Endpoint)</title>
          <description>The composite endpoint &quot;major adverse hematologic events&quot; (MAHE) included the following aspects of myelosuppression:&#xD;
All-cause hospitalizations - Each recorded preferred term (PT) with a unique start date was counted as an event.&#xD;
All-cause dose reductions - Dose reductions were permitted for E/P but not for trilaciclib or atezolizumab. No more than 2 dose reductions were allowed. Each dose reduction was counted as a separate event.&#xD;
Febrile neutropenia-Each febrile neutropenia event with a unique start date during the Induction Period was defined as a separate event.&#xD;
Prolonged severe neutropenia (SN)-Each cycle with a severe neutropenia duration greater than 5 days was counted as an event, with the date of the first Grade 4 laboratory value defined as the start date for the time-to-first event analysis.&#xD;
Red blood cell (RBC) transfusion on/after Week 5-Each RBC transfusion with a unique start date on/after Week 5 on study during the Induction Period was defined as a separate event.</description>
          <population>Intent-to-treat (ITT) analysis set included all randomized patients. Analysis using the ITT analysis set were conducted on the basis of the randomly assigned treatment.</population>
          <units>event rate per week</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Major adverse hematologic events (MAHE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.132"/>
                    <measurement group_id="O2" value="0.058"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>All-cause hospitalizations</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.032"/>
                    <measurement group_id="O2" value="0.030"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>All-cause dose reductions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.021"/>
                    <measurement group_id="O2" value="0.085"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Febrile neutropenia TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.002"/>
                    <measurement group_id="O2" value="0.004"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RBC transfusions on/after Week 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.017"/>
                    <measurement group_id="O2" value="0.026"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prolonged SN (&gt;5 days)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.005"/>
                    <measurement group_id="O2" value="0.170"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Best Overall Response</title>
        <description>For all patients, the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) tumor response data were used to determine each patient's visit response (TPR = time point response). Per RECIST v1.1 for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameters of target lesions; Progressive Disease (PD), &gt;=20% increase in the sum of the longest diameter of target lesions, Stable Disease, neither sufficient shrinkage or increase to quality for PR or PD. Objective Response Rate (ORR) = CR + PR. The TPR at each visit was determined in 2 ways: (1) derived programmatically at the time of analysis using the information from target lesions, non-target lesions, and new lesions based on data collected through eCRF; and (2) judged by the investigator as collected in the eCRF. Results shown here are from the programmatically derived assessments.</description>
        <time_frame>From date of randomization, up to four 21-day cycles of Induction therapy, followed by 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 724 days.</time_frame>
        <population>Response Evaluable Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>Trilaciclib+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received trilaciclib 240 mg/m² administered IV once daily on Days prior to E/P/A 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
          <group group_id="O2">
            <title>Placebo+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or discontinuation by the patient or investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Best Overall Response</title>
          <description>For all patients, the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) tumor response data were used to determine each patient's visit response (TPR = time point response). Per RECIST v1.1 for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameters of target lesions; Progressive Disease (PD), &gt;=20% increase in the sum of the longest diameter of target lesions, Stable Disease, neither sufficient shrinkage or increase to quality for PR or PD. Objective Response Rate (ORR) = CR + PR. The TPR at each visit was determined in 2 ways: (1) derived programmatically at the time of analysis using the information from target lesions, non-target lesions, and new lesions based on data collected through eCRF; and (2) judged by the investigator as collected in the eCRF. Results shown here are from the programmatically derived assessments.</description>
          <population>Response Evaluable Analysis Set</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Complete Response (CR)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Partial Response (PR)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stable Disease (SD)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Progressive Disease (PD)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Evaluable (NE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Objective response rate (CR+PR)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Objective Response (Complete Response or Partial Response)</title>
        <description>Duration of Response (DOR) is the time between first response by RECIST Version 1.1 of CR or PR and the first date that progressive disease is documented by RECIST Version 1.1, or death. Patients who do not experience PD or death will be censored at the last tumor assessment date. Only those patients with confirmed responses will be included in this analysis.</description>
        <time_frame>From date of randomization, up to four 21-day cycles of Induction therapy, followed by 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 724 days.</time_frame>
        <population>Response Evaluable Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>Trilaciclib+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
          <group group_id="O2">
            <title>Placebo+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Objective Response (Complete Response or Partial Response)</title>
          <description>Duration of Response (DOR) is the time between first response by RECIST Version 1.1 of CR or PR and the first date that progressive disease is documented by RECIST Version 1.1, or death. Patients who do not experience PD or death will be censored at the last tumor assessment date. Only those patients with confirmed responses will be included in this analysis.</description>
          <population>Response Evaluable Analysis Set</population>
          <units>months</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>25%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4" lower_limit="2.9" upper_limit="4.7"/>
                    <measurement group_id="O2" value="3.0" lower_limit="2.7" upper_limit="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Median</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6" lower_limit="4.4" upper_limit="7.0"/>
                    <measurement group_id="O2" value="4.3" lower_limit="3.4" upper_limit="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>75%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" lower_limit="5.8" upper_limit="13.2"/>
                    <measurement group_id="O2" value="5.0" lower_limit="4.6" upper_limit="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-Free Survival</title>
        <description>Progression-free survival (PFS) was defined as the time (number of months) from date of randomization until date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever came first.</description>
        <time_frame>From date of randomization, up to four 21-day cycles of Induction therapy, followed by 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 724 days.</time_frame>
        <population>Intent-to-treat</population>
        <group_list>
          <group group_id="O1">
            <title>Trilaciclib+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
          <group group_id="O2">
            <title>Placebo+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-Free Survival</title>
          <description>Progression-free survival (PFS) was defined as the time (number of months) from date of randomization until date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever came first.</description>
          <population>Intent-to-treat</population>
          <units>months</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>25%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" lower_limit="2.7" upper_limit="4.2"/>
                    <measurement group_id="O2" value="4.0" lower_limit="3.1" upper_limit="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Median</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9" lower_limit="4.2" upper_limit="7.1"/>
                    <measurement group_id="O2" value="5.4" lower_limit="4.3" upper_limit="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>75%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.5" lower_limit="7.1" upper_limit="10.4"/>
                    <measurement group_id="O2" value="6.4" lower_limit="5.7" upper_limit="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With at Least 1 Occurrence of Febrile Neutropenia</title>
        <description>The criterion for identifying febrile neutropenia was if the preferred term for an adverse event was &quot;FEBRILE NEUTROPENIA.&quot; Any occurrence of a febrile neutropenia event during the induction treatment period is defined as a binary variable (Yes or No); Yes if total number of febrile neutropenia events ≥ 1 is observed, No for other scenarios. Each febrile neutropenia event with a unique start date during the induction treatment period was defined as a separate event.</description>
        <time_frame>Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.</time_frame>
        <population>Intent-to-treat (ITT Analysis Set)</population>
        <group_list>
          <group group_id="O1">
            <title>Trilaciclib+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or discontinuation by the patient or investigator.</description>
          </group>
          <group group_id="O2">
            <title>Placebo+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or discontinuation by the patient or investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With at Least 1 Occurrence of Febrile Neutropenia</title>
          <description>The criterion for identifying febrile neutropenia was if the preferred term for an adverse event was &quot;FEBRILE NEUTROPENIA.&quot; Any occurrence of a febrile neutropenia event during the induction treatment period is defined as a binary variable (Yes or No); Yes if total number of febrile neutropenia events ≥ 1 is observed, No for other scenarios. Each febrile neutropenia event with a unique start date during the induction treatment period was defined as a separate event.</description>
          <population>Intent-to-treat (ITT Analysis Set)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With at Least 1 Occurrence of Grade 3 or 4 Hematologic Laboratory Abnormalities</title>
        <description>The occurrence of Grade 3 and 4 hematologic toxicities was a binary endpoint. If a patient had at least 1 cycle with at least 1 Grade 3 or 4 hematologic toxicities during the Induction Period, the patient was assigned as &quot;Yes&quot; to the occurrence of Grade 3 and 4 hematologic toxicities; otherwise, it was &quot;No&quot;. If a patient did not have an event, the value of 0 was assigned to that patient.</description>
        <time_frame>Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.</time_frame>
        <population>Intent-to-treat</population>
        <group_list>
          <group group_id="O1">
            <title>Trilaciclib+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
          <group group_id="O2">
            <title>Placebo+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With at Least 1 Occurrence of Grade 3 or 4 Hematologic Laboratory Abnormalities</title>
          <description>The occurrence of Grade 3 and 4 hematologic toxicities was a binary endpoint. If a patient had at least 1 cycle with at least 1 Grade 3 or 4 hematologic toxicities during the Induction Period, the patient was assigned as &quot;Yes&quot; to the occurrence of Grade 3 and 4 hematologic toxicities; otherwise, it was &quot;No&quot;. If a patient did not have an event, the value of 0 was assigned to that patient.</description>
          <population>Intent-to-treat</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With at Least 1 Occurrence of Erythropoiesis Stimulating Agent (ESA) Administration</title>
        <description>Any ESA administration in a cycle during the Induction Period was defined as a separate event. A patient with at least 1 cycle with ESA administration during an induction cycle or the Induction Period was considered to have occurrence of ESA administration. The criterion to select proper records was as follows: If the chemical subgroup from WHO-DD Version September 2017 (ie TEXT4 for CODE4) takes the value &quot;OTHER ANTIANEMIC PREPARATIONS,&quot; the medication was classified as ESAs.</description>
        <time_frame>Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.</time_frame>
        <population>Intent-to-treat</population>
        <group_list>
          <group group_id="O1">
            <title>Trilaciclib+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
          <group group_id="O2">
            <title>Placebo+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With at Least 1 Occurrence of Erythropoiesis Stimulating Agent (ESA) Administration</title>
          <description>Any ESA administration in a cycle during the Induction Period was defined as a separate event. A patient with at least 1 cycle with ESA administration during an induction cycle or the Induction Period was considered to have occurrence of ESA administration. The criterion to select proper records was as follows: If the chemical subgroup from WHO-DD Version September 2017 (ie TEXT4 for CODE4) takes the value &quot;OTHER ANTIANEMIC PREPARATIONS,&quot; the medication was classified as ESAs.</description>
          <population>Intent-to-treat</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With at Least 1 Occurrence of Platelet Transfusion</title>
        <description>Any occurrence of a platelet transfusion during the induction treatment period was defined as a binary variable (Yes or No); Yes if total number of febrile neutropenia events ≥ 1 is observed, No for other scenarios. If the patient did not have an event, the value of 0 was assigned to that patient. Each platelet transfusion event with a unique start date during the induction treatment period was defined as a separate event.</description>
        <time_frame>Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.</time_frame>
        <population>Intent-to-treat</population>
        <group_list>
          <group group_id="O1">
            <title>Trilaciclib+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
          <group group_id="O2">
            <title>Placebo+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With at Least 1 Occurrence of Platelet Transfusion</title>
          <description>Any occurrence of a platelet transfusion during the induction treatment period was defined as a binary variable (Yes or No); Yes if total number of febrile neutropenia events ≥ 1 is observed, No for other scenarios. If the patient did not have an event, the value of 0 was assigned to that patient. Each platelet transfusion event with a unique start date during the induction treatment period was defined as a separate event.</description>
          <population>Intent-to-treat</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With at Least 1 Occurrence of Infection Serious Adverse Events (SAEs)</title>
        <description>Any occurrence of an infection SAE during the induction treatment period was defined as a binary variable (Yes or No); Yes if total number of febrile neutropenia events ≥ 1 is observed, No for other scenarios. If the patient did not have an event, the value of 0 was assigned to that patient. The criterion for identifying the proper infection SAE records was as follows: if the system organ class (SOC) from Medical Dictionary for Regulatory Activities (MedDRA) Version 20.1 takes value &quot;INFECTIONS AND INFESTATIONS,&quot; and the AE was a serious event.</description>
        <time_frame>Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.</time_frame>
        <population>Intent-to-treat</population>
        <group_list>
          <group group_id="O1">
            <title>Trilaciclib+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
          <group group_id="O2">
            <title>Placebo+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With at Least 1 Occurrence of Infection Serious Adverse Events (SAEs)</title>
          <description>Any occurrence of an infection SAE during the induction treatment period was defined as a binary variable (Yes or No); Yes if total number of febrile neutropenia events ≥ 1 is observed, No for other scenarios. If the patient did not have an event, the value of 0 was assigned to that patient. The criterion for identifying the proper infection SAE records was as follows: if the system organ class (SOC) from Medical Dictionary for Regulatory Activities (MedDRA) Version 20.1 takes value &quot;INFECTIONS AND INFESTATIONS,&quot; and the AE was a serious event.</description>
          <population>Intent-to-treat</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With at Least 1 Occurrence of Pulmonary Infection Serious Adverse Events (SAEs)</title>
        <description>Any occurrence of a pulmonary SAE during the induction treatment period was defined as a binary variable (Yes or No); Yes if total number of febrile neutropenia events ≥ 1 is observed, No for other scenarios. If the patient did not have an event, the value of 0 was assigned to that patient. Each pulmonary infection SAE with a unique start date during the induction treatment period was defined as separate event. The criterion for identifying the proper pulmonary infection SAE records was as follows:&#xD;
The SOC from MedDRA Version 20.1 took the value &quot;INFECTIONS AND INFESTATIONS,&quot; the adverse event was a serious event, and the PT took values from the following list of PTs under the category of pulmonary infection adverse events: bronchiolitis, bronchitis, infectious pleural effusion, influenza, pneumonia, pneumonia bacterial, respiratory tract infection, upper respiratory tract infection, and viral upper respiratory tract infection.</description>
        <time_frame>Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.</time_frame>
        <population>Intent-to-treat</population>
        <group_list>
          <group group_id="O1">
            <title>Trilaciclib+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
          <group group_id="O2">
            <title>Placebo+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients will receive placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² will be administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin will be administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg will be administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients will receive maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With at Least 1 Occurrence of Pulmonary Infection Serious Adverse Events (SAEs)</title>
          <description>Any occurrence of a pulmonary SAE during the induction treatment period was defined as a binary variable (Yes or No); Yes if total number of febrile neutropenia events ≥ 1 is observed, No for other scenarios. If the patient did not have an event, the value of 0 was assigned to that patient. Each pulmonary infection SAE with a unique start date during the induction treatment period was defined as separate event. The criterion for identifying the proper pulmonary infection SAE records was as follows:&#xD;
The SOC from MedDRA Version 20.1 took the value &quot;INFECTIONS AND INFESTATIONS,&quot; the adverse event was a serious event, and the PT took values from the following list of PTs under the category of pulmonary infection adverse events: bronchiolitis, bronchitis, infectious pleural effusion, influenza, pneumonia, pneumonia bacterial, respiratory tract infection, upper respiratory tract infection, and viral upper respiratory tract infection.</description>
          <population>Intent-to-treat</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With at Least 1 Occurrence of IV Antibiotic Uses</title>
        <description>Occurrence of an IV antibiotics administration during the induction treatment period is defined as a binary variable (Yes or No); Yes if total number of IV antibiotics administration ≥ 1 is observed, No for other scenarios. Each IV antibiotic with a unique start date during the induction treatment period will be defined as a separate event. The criteria for identifying an IV antibiotic administration event was (1) if the therapeutic subgroup from WHO-DD Version September 2017 (ie, TEXT2 for CODE2) takes the value &quot;ANTIBACTERIALS FOR SYSTEMIC USE,&quot; and (2) the route of medication was &quot;intravenous&quot; or the route was &quot;other&quot; with the detailed specification as &quot;IVPB.&quot;</description>
        <time_frame>Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.</time_frame>
        <population>Intent-to-treat</population>
        <group_list>
          <group group_id="O1">
            <title>Trilaciclib+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
          <group group_id="O2">
            <title>Placebo+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m2 was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With at Least 1 Occurrence of IV Antibiotic Uses</title>
          <description>Occurrence of an IV antibiotics administration during the induction treatment period is defined as a binary variable (Yes or No); Yes if total number of IV antibiotics administration ≥ 1 is observed, No for other scenarios. Each IV antibiotic with a unique start date during the induction treatment period will be defined as a separate event. The criteria for identifying an IV antibiotic administration event was (1) if the therapeutic subgroup from WHO-DD Version September 2017 (ie, TEXT2 for CODE2) takes the value &quot;ANTIBACTERIALS FOR SYSTEMIC USE,&quot; and (2) the route of medication was &quot;intravenous&quot; or the route was &quot;other&quot; with the detailed specification as &quot;IVPB.&quot;</description>
          <population>Intent-to-treat</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Study Drug Exposure (Induction Period and Maintenance Period)</title>
        <description>Induction period duration of exposure (days) = Day 1 of last induction cycle - Cycle 1 Day 1 of induction phase + 21. Maintenance period duration of exposure (days) = Day 1 of the last maintenance cycle -Cycle 1 Day 1 of maintenance phase + 21.</description>
        <time_frame>From date of first dose, up to four 21-day cycles of Induction therapy, followed by 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 1162 days.</time_frame>
        <population>Safety analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Trilaciclib+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
          <group group_id="O2">
            <title>Placebo+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Study Drug Exposure (Induction Period and Maintenance Period)</title>
          <description>Induction period duration of exposure (days) = Day 1 of last induction cycle - Cycle 1 Day 1 of induction phase + 21. Maintenance period duration of exposure (days) = Day 1 of the last maintenance cycle -Cycle 1 Day 1 of maintenance phase + 21.</description>
          <population>Safety analysis</population>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Induction Period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83" spread="15.6"/>
                    <measurement group_id="O2" value="88" spread="20.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maintenance Period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="223" spread="253.3"/>
                    <measurement group_id="O2" value="232" spread="271.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Cycles Completed (Induction Period and Maintenance Period)</title>
        <description>Patients were considered to have started a cycle if they have received at least one dose of any study drug (carboplatin, etoposide, atezolizumab or trilaciclib).</description>
        <time_frame>From date of first dose, up to four 21-day cycles of Induction therapy, followed by 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 49 cycles.</time_frame>
        <population>Safety analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Trilaciclib+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
          <group group_id="O2">
            <title>Placebo+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Cycles Completed (Induction Period and Maintenance Period)</title>
          <description>Patients were considered to have started a cycle if they have received at least one dose of any study drug (carboplatin, etoposide, atezolizumab or trilaciclib).</description>
          <population>Safety analysis</population>
          <units>Cycles</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Induction Period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" spread="0.6"/>
                    <measurement group_id="O2" value="4" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maintenance Period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" spread="11.9"/>
                    <measurement group_id="O2" value="10" spread="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Relative Dose Intensity of Trilaciclib/Placebo, Carboplatin, Etoposide, Atezolizumab (Induction Period) and Atezolizumab (Maintenance Period)</title>
        <description>Relative dose intensity is defined as 100% times the actual dose intensity divided by the planned dose intensity. The planned dose intensity is defined as the cumulative planned dose through the study divided by (number of cycles * 3 weeks)</description>
        <time_frame>From date of first dose, up to four 21-day cycles of Induction therapy, followed by 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 724 days.</time_frame>
        <population>Safety Analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Trilaciclib+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
          <group group_id="O2">
            <title>Placebo+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Relative Dose Intensity of Trilaciclib/Placebo, Carboplatin, Etoposide, Atezolizumab (Induction Period) and Atezolizumab (Maintenance Period)</title>
          <description>Relative dose intensity is defined as 100% times the actual dose intensity divided by the planned dose intensity. The planned dose intensity is defined as the cumulative planned dose through the study divided by (number of cycles * 3 weeks)</description>
          <population>Safety Analysis</population>
          <units>percentage of dose</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Trilaciclib/Placebo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.6" spread="7.65"/>
                    <measurement group_id="O2" value="91.1" spread="10.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Carboplatin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.3" spread="7.65"/>
                    <measurement group_id="O2" value="89.1" spread="12.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Etoposide</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.4" spread="9.59"/>
                    <measurement group_id="O2" value="87.7" spread="13.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Atezolizumab (Induction)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.1" spread="9.54"/>
                    <measurement group_id="O2" value="91.0" spread="11.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Atezolizumab (Maintenance)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.5" spread="11.45"/>
                    <measurement group_id="O2" value="94.2" spread="10.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Any Cycle Delays and the Number of Cycles Delayed (Induction Period)</title>
        <description>After Cycle 1, patients need to meet pre-specified laboratory parameter criteria before initiating Cycle 2 and each subsequent cycle of chemotherapy. A &quot;Cycle Day Status&quot; page asks if the cycle was delayed. If the start of the current cycle was delayed (the site answers &quot;Yes&quot;), this will be counted as a delay. Cycle delays could occur for management of toxicity (hematologic or non-hematologic) or for administrative/logistic reasons. The reason for each cycle delay was captured in the eCRF if it was related to AEs. Reasons other than AEs were not captured.</description>
        <time_frame>Induction Period. From date of first dose, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.</time_frame>
        <population>Safety analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Trilaciclib+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
          <group group_id="O2">
            <title>Placebo+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Any Cycle Delays and the Number of Cycles Delayed (Induction Period)</title>
          <description>After Cycle 1, patients need to meet pre-specified laboratory parameter criteria before initiating Cycle 2 and each subsequent cycle of chemotherapy. A &quot;Cycle Day Status&quot; page asks if the cycle was delayed. If the start of the current cycle was delayed (the site answers &quot;Yes&quot;), this will be counted as a delay. Cycle delays could occur for management of toxicity (hematologic or non-hematologic) or for administrative/logistic reasons. The reason for each cycle delay was captured in the eCRF if it was related to AEs. Reasons other than AEs were not captured.</description>
          <population>Safety analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of patients with any cycle delays</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0 cycles</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 cycle</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 cycles</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 or more cycles</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Any Cycle Delays and the Number of Cycles Delayed (Maintenance Period)</title>
        <description>After Cycle 1, patients need to meet pre-specified laboratory parameter criteria before initiating Cycle 2 and each subsequent cycle of chemotherapy. A &quot;Cycle Day Status&quot; page asks if the cycle was delayed. If the start of the current cycle was delayed (the site answers &quot;Yes&quot;), this will be counted as a delay. Cycle delays could occur for management of toxicity (hematologic or non-hematologic) or for administrative/logistic reasons. The reason for each cycle delay was captured in the eCRF if it was related to AEs. Reasons other than AEs were not captured.</description>
        <time_frame>Maintenance Period. From date of first maintenance dose, 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 1160 days.</time_frame>
        <population>Safety analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Trilaciclib+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
          <group group_id="O2">
            <title>Placebo+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was be administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Any Cycle Delays and the Number of Cycles Delayed (Maintenance Period)</title>
          <description>After Cycle 1, patients need to meet pre-specified laboratory parameter criteria before initiating Cycle 2 and each subsequent cycle of chemotherapy. A &quot;Cycle Day Status&quot; page asks if the cycle was delayed. If the start of the current cycle was delayed (the site answers &quot;Yes&quot;), this will be counted as a delay. Cycle delays could occur for management of toxicity (hematologic or non-hematologic) or for administrative/logistic reasons. The reason for each cycle delay was captured in the eCRF if it was related to AEs. Reasons other than AEs were not captured.</description>
          <population>Safety analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of patients with any cycle delays</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0 cycles</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 cycle</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 cycles</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 or more cycles</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Any Missed Doses [for Each Study Drug: Trilaciclib/Placebo, Carboplatin and Etoposide] (Induction Period)</title>
        <description>Missed doses are identified on the dosing page of each study drug based on the question &quot;Was the dose given?&quot;. The missed dose information will be obtained for each study drug. For a study drug, if the last record of response to question &quot;Was the dose given?&quot; is No, it will not be considered as a missed dose but instead considered to be end of treatment if both criteria below are met: (1) No other study drugs are given on the same day, and (2) No study drugs are given subsequently.</description>
        <time_frame>Induction Period. From date of first dose, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.</time_frame>
        <population>Safety analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Trilaciclib+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
          <group group_id="O2">
            <title>Placebo+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients receives maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Any Missed Doses [for Each Study Drug: Trilaciclib/Placebo, Carboplatin and Etoposide] (Induction Period)</title>
          <description>Missed doses are identified on the dosing page of each study drug based on the question &quot;Was the dose given?&quot;. The missed dose information will be obtained for each study drug. For a study drug, if the last record of response to question &quot;Was the dose given?&quot; is No, it will not be considered as a missed dose but instead considered to be end of treatment if both criteria below are met: (1) No other study drugs are given on the same day, and (2) No study drugs are given subsequently.</description>
          <population>Safety analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Trilaciclib/Placebo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Carboplatin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Etoposide</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Any Missed Doses of Atezolizumab (Overall Treatment Period)</title>
        <description>Missed doses are identified on the dosing page of each study drug based on the question &quot;Was the dose given?&quot;. The missed dose information will be obtained for each study drug. For a study drug, if the last record of response to question &quot;Was the dose given?&quot; is No, it will not be considered as a missed dose but instead considered to be end of treatment if both criteria below are met: (1) No other study drugs are given on the same day, and (2) No study drugs are given subsequently.</description>
        <time_frame>From date of first dose, up to four 21-day cycles of Induction therapy, followed by 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 1162 days.</time_frame>
        <population>Safety analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Trilaciclib+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
          <group group_id="O2">
            <title>Placebo+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Any Missed Doses of Atezolizumab (Overall Treatment Period)</title>
          <description>Missed doses are identified on the dosing page of each study drug based on the question &quot;Was the dose given?&quot;. The missed dose information will be obtained for each study drug. For a study drug, if the last record of response to question &quot;Was the dose given?&quot; is No, it will not be considered as a missed dose but instead considered to be end of treatment if both criteria below are met: (1) No other study drugs are given on the same day, and (2) No study drugs are given subsequently.</description>
          <population>Safety analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Any Dose Interruptions [for Each Study Drug: Trilaciclib/Placebo, Carboplatin and Etoposide] (Induction Period)</title>
        <description>Dose interruptions were defined as interruption of infusion, regardless of whether the study drug was continued after the interruption.</description>
        <time_frame>Induction Period. From date of first dose, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.</time_frame>
        <population>Safety analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Trilaciclib+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
          <group group_id="O2">
            <title>Placebo+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Any Dose Interruptions [for Each Study Drug: Trilaciclib/Placebo, Carboplatin and Etoposide] (Induction Period)</title>
          <description>Dose interruptions were defined as interruption of infusion, regardless of whether the study drug was continued after the interruption.</description>
          <population>Safety analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Trilaciclib/placebo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Carboplatin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Etoposide</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Any Interrupted Doses of Atezolizumab (Overall Treatment Period)</title>
        <description>Dose interruptions were defined as interruption of infusion, regardless of whether the study drug was continued after the interruption.</description>
        <time_frame>From date of first dose, up to four 21-day cycles of Induction therapy, followed by 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 1162 days.</time_frame>
        <population>Safety analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Trilaciclib+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
          <group group_id="O2">
            <title>Placebo+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Any Interrupted Doses of Atezolizumab (Overall Treatment Period)</title>
          <description>Dose interruptions were defined as interruption of infusion, regardless of whether the study drug was continued after the interruption.</description>
          <population>Safety analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Any Dose Reductions of Carboplatin and Etoposide (Induction Period)</title>
        <description>No dose reductions were allowed for trilaciclib or atezolizumab during the study.</description>
        <time_frame>Induction Period. From date of first dose, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.</time_frame>
        <population>Safety analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Trilaciclib+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
          <group group_id="O2">
            <title>Placebo+Etoposide/Carboplatin/Atezolizumab</title>
            <description>Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Any Dose Reductions of Carboplatin and Etoposide (Induction Period)</title>
          <description>No dose reductions were allowed for trilaciclib or atezolizumab during the study.</description>
          <population>Safety analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Etoposide</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Carboplatin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Treatment-emergent adverse events collected beginning with informed consent through 30 days after last dose of study drug. Treatment emergent serious adverse events collected through 90 days after last dose of study drug, assessed up to a maximum of 1192 days (maximum duration of exposure plus 30 days).</time_frame>
      <desc>Adverse events were assessed using the safety analysis set, which included all randomized patients who received at least 1 dose of any study drug (etoposide, carboplatin, atezolizumab, or trilaciclib). Analyses using the safety analysis set were conducted based on the actual treatment received.</desc>
      <group_list>
        <group group_id="E1">
          <title>Trilaciclib+Etoposide/Carboplatin/Atezolizumab</title>
          <description>Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
        </group>
        <group group_id="E2">
          <title>Placebo+Etoposide/Carboplatin/Atezolizumab</title>
          <description>Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.&#xD;
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA version 23.1.</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="42" subjects_at_risk="54"/>
                <counts group_id="E2" subjects_affected="44" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Inappropriate antidiuretic hormone secretion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Retroperitoneal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Empyema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Meningoencephalitis herpetic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Balance disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Cognitive disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Generalised tonic-clonic seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Paraneoplastic neurological syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Angioedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA version 23.1.</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="49" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="52" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="60" subjects_affected="19" subjects_at_risk="52"/>
                <counts group_id="E2" events="122" subjects_affected="32" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="35" subjects_affected="19" subjects_at_risk="52"/>
                <counts group_id="E2" events="85" subjects_affected="28" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="14" subjects_affected="7" subjects_at_risk="52"/>
                <counts group_id="E2" events="44" subjects_affected="21" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E2" events="38" subjects_affected="14" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="36" subjects_affected="20" subjects_at_risk="52"/>
                <counts group_id="E2" events="30" subjects_affected="18" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E2" events="15" subjects_affected="12" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="13" subjects_affected="9" subjects_at_risk="52"/>
                <counts group_id="E2" events="10" subjects_affected="6" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="10" subjects_affected="6" subjects_at_risk="52"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="24" subjects_affected="16" subjects_at_risk="52"/>
                <counts group_id="E2" events="32" subjects_affected="20" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="17" subjects_affected="8" subjects_at_risk="52"/>
                <counts group_id="E2" events="21" subjects_affected="9" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="52"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" events="11" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="10" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E2" events="63" subjects_affected="13" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="11" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E2" events="50" subjects_affected="11" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="20" subjects_affected="7" subjects_at_risk="52"/>
                <counts group_id="E2" events="25" subjects_affected="6" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="11" subjects_affected="6" subjects_at_risk="52"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="10" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E2" events="6" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Blood lactate dehydrogenase increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E2" events="8" subjects_affected="4" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="10" subjects_affected="5" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E2" events="11" subjects_affected="9" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="11" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="13" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="10" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="11" subjects_affected="9" subjects_at_risk="52"/>
                <counts group_id="E2" events="13" subjects_affected="9" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="13" subjects_affected="9" subjects_at_risk="52"/>
                <counts group_id="E2" events="9" subjects_affected="6" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="8" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" events="4" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="13" subjects_affected="8" subjects_at_risk="52"/>
                <counts group_id="E2" events="20" subjects_affected="13" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="52"/>
                <counts group_id="E2" events="12" subjects_affected="8" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="52"/>
                <counts group_id="E2" events="21" subjects_affected="18" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="52"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="10" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" events="11" subjects_affected="3" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Phlebitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
    </certain_agreements>
    <limitations_and_caveats>Limitation of the trial is small numbers of subjects, since it is a Phase 2 clinical trial.&#xD;
Small sample size may have reduced the ability to observe statistically significant treatment effects on secondary myelopreservation measures (i.e. occurrence of FN AEs, infections and antibiotics usage).</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Clinical Trial Info.</name_or_title>
      <organization>G1 Therapeutics, Inc.</organization>
      <phone>919-213-9835</phone>
      <email>clinicalinfo@g1therapeutics.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03041311
org study id: G1T28-05
secondary id: 2017-000358-20
nct id: NCT03041311
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This was a study to investigate the potential clinical benefit of trilaciclib (G1T28) in
      preserving the bone marrow and the immune system, and enhancing antitumor efficacy when
      administered with carboplatin, etoposide, and atezolizumab (E/P/A) therapy in first line
      treatment for patients with newly diagnosed extensive-stage SCLC.

      The study was a randomized, double-blinded, placebo-controlled design. Approximately, 100
      patients were randomized to trilaciclib + E/P/A or placebo + E/P/A in the study.
The posted results represent the final results from Study G1T28-05, a Phase 2 study of
      carboplatin, etoposide, and atezolizumab with or without trilaciclib (G1T28) in patients with
      untreated extensive-stage small cell lung cancer (SCLC).

      The final myelopreservation efficacy results are from database lock 1 (data cut-off [DCO] 17
      Aug 2018). The final anti-tumor efficacy data (BOR, DOR, PFS) are from a second database lock
      2 (DCO 28 June 2019) that occurred to support the trilaciclib New Drug Application (NDA).
      Final overall survival and safety data are reported from the final study database lock (DCO
      11 Dec 2020, last patient last visit date of 29 October 2020).

      Please note the last patient last visit date description above which is recorded as the study
      completion date. Following the last patient last visit, the final database lock occurred a
      few weeks later which accounts for the discrepancy between the study completion date and the
      reported assessment time frames.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Duration of Severe (Grade 4) Neutropenia in Cycle 1
time frame: Evaluated for Cycle 1 of the Induction Period (i.e., from randomization to the end of Cycle 1, each cycle = 21 days).
description: Duration of severe neutropenia (DSN; days) was defined as the number of days from the date of the first absolute neutrophil count (ANC) value of <0.5 × 10⁹/L observed between start of cycle and end of cycle to the date of the first ANC value ≥0.5 × 10⁹/L that met the following criteria: (1) occurred after the ANC value of <0.5 × 10⁹/L and (2) no other ANC values <0.5 × 10⁹/L occurred between this day and end of cycle. DSN was set to 0 for patients who did not experience severe neutropenia in a cycle, including those that were randomized and not treated. Data from unscheduled visits and the actual assessment date (rather than visit date) were included in the derivation.
measure: Number of Participants With at Least 1 Occurrence of Severe (Grade 4) Neutropenia
time frame: Induction Period. From date of randomization, 21 day treatment cycles up to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.
description: The occurrence of severe (Grade 4) neutropenia (SN) was a binary variable. If a patient had at least 1 absolute neutrophil count value <0.5 × 10^9/L during the Induction Period, the patient was assigned as Yes to the occurrence of SN; otherwise, it was No.
measure: All-Cause Dose Reductions
time frame: Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.
description: Dose reductions are not permitted for trilaciclib or atezolizumab. Dose reductions for E/P are derived from changes in the protocol-specified dose on the dosing page and correspond to the reductions for toxicity specified in the protocol. No more than 2 dose reductions of E/P in total were allowed for any patient. Simultaneous reduction in the doses of etoposide and carboplatin were counted as 1 dose reduction.
measure: Number of Participants With at Least 1 Occurrence of RBC Transfusion on/After Week 5 (Proportion of Patients)
time frame: Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 374 days.
description: For this endpoint, the occurrence during the Induction Period was defined as a binary variable (Yes or No); Yes, if total number of events ≥1 was observed, No for other scenarios. If a patient did not have an event, a value of 0 was assigned to that patient. Each red blood cell transfusion with a unique start date on/after Week 5 on study during the Induction was defined as a separate event.
measure: Occurrence of Granulocyte Colony-Stimulating Factor (G-CSF) Administration (Proportion of Patients)
time frame: Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.
description: For this endpoint, the occurrence during the Induction Period was defined as a binary variable (Yes or No); Yes, if total number of events ≥1 was observed, No for other scenarios. If a patient did not have an event, a value of 0 was assigned to that patient. Any G-CSF administration in a cycle during the Induction Period was defined as a separate event. A patient with at least 1 cycle with G-CSF administration during an induction cycle or the Induction Period was considered to have occurrence of G-CSF administration.
measure: Overall Survival (OS)
time frame: From date of randomization to date of death due to any cause, assessed up to a maximum of 38.1 months.
description: Overall survival was calculated as the time (months) from date of randomization to the date of death due to any cause. Patients who did not die during the study were censored at the date last known to be alive. Patients lacking data beyond the date of randomization had their survival time censored at date of randomization. Overall survival was not censored if a patient received other anti-tumor treatments after the study drugs. Overall survival was calculated using the Kaplan-Meier method.
measure: Major Adverse Hematologic Events (MAHE) (Composite Endpoint)
time frame: Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.
description: The composite endpoint "major adverse hematologic events" (MAHE) included the following aspects of myelosuppression:
All-cause hospitalizations - Each recorded preferred term (PT) with a unique start date was counted as an event.
All-cause dose reductions - Dose reductions were permitted for E/P but not for trilaciclib or atezolizumab. No more than 2 dose reductions were allowed. Each dose reduction was counted as a separate event.
Febrile neutropenia-Each febrile neutropenia event with a unique start date during the Induction Period was defined as a separate event.
Prolonged severe neutropenia (SN)-Each cycle with a severe neutropenia duration greater than 5 days was counted as an event, with the date of the first Grade 4 laboratory value defined as the start date for the time-to-first event analysis.
Red blood cell (RBC) transfusion on/after Week 5-Each RBC transfusion with a unique start date on/after Week 5 on study during the Induction Period was defined as a separate event.
measure: Best Overall Response
time frame: From date of randomization, up to four 21-day cycles of Induction therapy, followed by 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 724 days.
description: For all patients, the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) tumor response data were used to determine each patient's visit response (TPR = time point response). Per RECIST v1.1 for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameters of target lesions; Progressive Disease (PD), >=20% increase in the sum of the longest diameter of target lesions, Stable Disease, neither sufficient shrinkage or increase to quality for PR or PD. Objective Response Rate (ORR) = CR + PR. The TPR at each visit was determined in 2 ways: (1) derived programmatically at the time of analysis using the information from target lesions, non-target lesions, and new lesions based on data collected through eCRF; and (2) judged by the investigator as collected in the eCRF. Results shown here are from the programmatically derived assessments.
measure: Duration of Objective Response (Complete Response or Partial Response)
time frame: From date of randomization, up to four 21-day cycles of Induction therapy, followed by 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 724 days.
description: Duration of Response (DOR) is the time between first response by RECIST Version 1.1 of CR or PR and the first date that progressive disease is documented by RECIST Version 1.1, or death. Patients who do not experience PD or death will be censored at the last tumor assessment date. Only those patients with confirmed responses will be included in this analysis.
measure: Progression-Free Survival
time frame: From date of randomization, up to four 21-day cycles of Induction therapy, followed by 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 724 days.
description: Progression-free survival (PFS) was defined as the time (number of months) from date of randomization until date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever came first.
measure: Number of Participants With at Least 1 Occurrence of Febrile Neutropenia
time frame: Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.
description: The criterion for identifying febrile neutropenia was if the preferred term for an adverse event was "FEBRILE NEUTROPENIA." Any occurrence of a febrile neutropenia event during the induction treatment period is defined as a binary variable (Yes or No); Yes if total number of febrile neutropenia events ≥ 1 is observed, No for other scenarios. Each febrile neutropenia event with a unique start date during the induction treatment period was defined as a separate event.
measure: Number of Participants With at Least 1 Occurrence of Grade 3 or 4 Hematologic Laboratory Abnormalities
time frame: Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.
description: The occurrence of Grade 3 and 4 hematologic toxicities was a binary endpoint. If a patient had at least 1 cycle with at least 1 Grade 3 or 4 hematologic toxicities during the Induction Period, the patient was assigned as "Yes" to the occurrence of Grade 3 and 4 hematologic toxicities; otherwise, it was "No". If a patient did not have an event, the value of 0 was assigned to that patient.
measure: Number of Participants With at Least 1 Occurrence of Erythropoiesis Stimulating Agent (ESA) Administration
time frame: Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.
description: Any ESA administration in a cycle during the Induction Period was defined as a separate event. A patient with at least 1 cycle with ESA administration during an induction cycle or the Induction Period was considered to have occurrence of ESA administration. The criterion to select proper records was as follows: If the chemical subgroup from WHO-DD Version September 2017 (ie TEXT4 for CODE4) takes the value "OTHER ANTIANEMIC PREPARATIONS," the medication was classified as ESAs.
measure: Number of Participants With at Least 1 Occurrence of Platelet Transfusion
time frame: Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.
description: Any occurrence of a platelet transfusion during the induction treatment period was defined as a binary variable (Yes or No); Yes if total number of febrile neutropenia events ≥ 1 is observed, No for other scenarios. If the patient did not have an event, the value of 0 was assigned to that patient. Each platelet transfusion event with a unique start date during the induction treatment period was defined as a separate event.
measure: Number of Participants With at Least 1 Occurrence of Infection Serious Adverse Events (SAEs)
time frame: Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.
description: Any occurrence of an infection SAE during the induction treatment period was defined as a binary variable (Yes or No); Yes if total number of febrile neutropenia events ≥ 1 is observed, No for other scenarios. If the patient did not have an event, the value of 0 was assigned to that patient. The criterion for identifying the proper infection SAE records was as follows: if the system organ class (SOC) from Medical Dictionary for Regulatory Activities (MedDRA) Version 20.1 takes value "INFECTIONS AND INFESTATIONS," and the AE was a serious event.
measure: Number of Participants With at Least 1 Occurrence of Pulmonary Infection Serious Adverse Events (SAEs)
time frame: Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.
description: Any occurrence of a pulmonary SAE during the induction treatment period was defined as a binary variable (Yes or No); Yes if total number of febrile neutropenia events ≥ 1 is observed, No for other scenarios. If the patient did not have an event, the value of 0 was assigned to that patient. Each pulmonary infection SAE with a unique start date during the induction treatment period was defined as separate event. The criterion for identifying the proper pulmonary infection SAE records was as follows:
The SOC from MedDRA Version 20.1 took the value "INFECTIONS AND INFESTATIONS," the adverse event was a serious event, and the PT took values from the following list of PTs under the category of pulmonary infection adverse events: bronchiolitis, bronchitis, infectious pleural effusion, influenza, pneumonia, pneumonia bacterial, respiratory tract infection, upper respiratory tract infection, and viral upper respiratory tract infection.
measure: Number of Participants With at Least 1 Occurrence of IV Antibiotic Uses
time frame: Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.
description: Occurrence of an IV antibiotics administration during the induction treatment period is defined as a binary variable (Yes or No); Yes if total number of IV antibiotics administration ≥ 1 is observed, No for other scenarios. Each IV antibiotic with a unique start date during the induction treatment period will be defined as a separate event. The criteria for identifying an IV antibiotic administration event was (1) if the therapeutic subgroup from WHO-DD Version September 2017 (ie, TEXT2 for CODE2) takes the value "ANTIBACTERIALS FOR SYSTEMIC USE," and (2) the route of medication was "intravenous" or the route was "other" with the detailed specification as "IVPB."
measure: Duration of Study Drug Exposure (Induction Period and Maintenance Period)
time frame: From date of first dose, up to four 21-day cycles of Induction therapy, followed by 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 1162 days.
description: Induction period duration of exposure (days) = Day 1 of last induction cycle - Cycle 1 Day 1 of induction phase + 21. Maintenance period duration of exposure (days) = Day 1 of the last maintenance cycle -Cycle 1 Day 1 of maintenance phase + 21.
measure: Number of Cycles Completed (Induction Period and Maintenance Period)
time frame: From date of first dose, up to four 21-day cycles of Induction therapy, followed by 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 49 cycles.
description: Patients were considered to have started a cycle if they have received at least one dose of any study drug (carboplatin, etoposide, atezolizumab or trilaciclib).
measure: Relative Dose Intensity of Trilaciclib/Placebo, Carboplatin, Etoposide, Atezolizumab (Induction Period) and Atezolizumab (Maintenance Period)
time frame: From date of first dose, up to four 21-day cycles of Induction therapy, followed by 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 724 days.
description: Relative dose intensity is defined as 100% times the actual dose intensity divided by the planned dose intensity. The planned dose intensity is defined as the cumulative planned dose through the study divided by (number of cycles * 3 weeks)
measure: Number of Participants With Any Cycle Delays and the Number of Cycles Delayed (Induction Period)
time frame: Induction Period. From date of first dose, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.
description: After Cycle 1, patients need to meet pre-specified laboratory parameter criteria before initiating Cycle 2 and each subsequent cycle of chemotherapy. A "Cycle Day Status" page asks if the cycle was delayed. If the start of the current cycle was delayed (the site answers "Yes"), this will be counted as a delay. Cycle delays could occur for management of toxicity (hematologic or non-hematologic) or for administrative/logistic reasons. The reason for each cycle delay was captured in the eCRF if it was related to AEs. Reasons other than AEs were not captured.
measure: Number of Participants With Any Cycle Delays and the Number of Cycles Delayed (Maintenance Period)
time frame: Maintenance Period. From date of first maintenance dose, 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 1160 days.
description: After Cycle 1, patients need to meet pre-specified laboratory parameter criteria before initiating Cycle 2 and each subsequent cycle of chemotherapy. A "Cycle Day Status" page asks if the cycle was delayed. If the start of the current cycle was delayed (the site answers "Yes"), this will be counted as a delay. Cycle delays could occur for management of toxicity (hematologic or non-hematologic) or for administrative/logistic reasons. The reason for each cycle delay was captured in the eCRF if it was related to AEs. Reasons other than AEs were not captured.
measure: Number of Participants With Any Missed Doses [for Each Study Drug: Trilaciclib/Placebo, Carboplatin and Etoposide] (Induction Period)
time frame: Induction Period. From date of first dose, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.
description: Missed doses are identified on the dosing page of each study drug based on the question "Was the dose given?". The missed dose information will be obtained for each study drug. For a study drug, if the last record of response to question "Was the dose given?" is No, it will not be considered as a missed dose but instead considered to be end of treatment if both criteria below are met: (1) No other study drugs are given on the same day, and (2) No study drugs are given subsequently.
measure: Number of Participants With Any Missed Doses of Atezolizumab (Overall Treatment Period)
time frame: From date of first dose, up to four 21-day cycles of Induction therapy, followed by 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 1162 days.
description: Missed doses are identified on the dosing page of each study drug based on the question "Was the dose given?". The missed dose information will be obtained for each study drug. For a study drug, if the last record of response to question "Was the dose given?" is No, it will not be considered as a missed dose but instead considered to be end of treatment if both criteria below are met: (1) No other study drugs are given on the same day, and (2) No study drugs are given subsequently.
measure: Number of Participants With Any Dose Interruptions [for Each Study Drug: Trilaciclib/Placebo, Carboplatin and Etoposide] (Induction Period)
time frame: Induction Period. From date of first dose, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.
description: Dose interruptions were defined as interruption of infusion, regardless of whether the study drug was continued after the interruption.
measure: Number of Participants With Any Interrupted Doses of Atezolizumab (Overall Treatment Period)
time frame: From date of first dose, up to four 21-day cycles of Induction therapy, followed by 21 day cycles of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the patient or investigator, assessed up to 1162 days.
description: Dose interruptions were defined as interruption of infusion, regardless of whether the study drug was continued after the interruption.
measure: Number of Participants With Any Dose Reductions of Carboplatin and Etoposide (Induction Period)
time frame: Induction Period. From date of first dose, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.
description: No dose reductions were allowed for trilaciclib or atezolizumab during the study.
arm group label: trilaciclib+etoposide/carboplatin/atezolizumab
arm group type: Experimental
description: Induction: Patients received trilaciclib 240 mg/m² administered intravenously (IV) once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target area under the concentration-time curve (AUC) = 5 milligrams per milliliter per minute (mg/mL/min) to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or discontinuation by the patient or investigator.
arm group label: placebo+etoposide/carboplatin/atezolizumab
arm group type: Experimental
description: Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was be administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.
Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity or discontinuation by the patient or investigator.
intervention type: Drug
intervention name: Trilaciclib
description: Trilaciclib IV
arm group label: trilaciclib+etoposide/carboplatin/atezolizumab
other name: G1T28
intervention type: Drug
intervention name: Placebo
description: Placebo IV
arm group label: placebo+etoposide/carboplatin/atezolizumab
intervention type: Drug
intervention name: Carboplatin
description: Carboplatin IV
arm group label: placebo+etoposide/carboplatin/atezolizumab
arm group label: trilaciclib+etoposide/carboplatin/atezolizumab
other name: Paraplatin
intervention type: Drug
intervention name: Etoposide
description: Etoposide IV
arm group label: placebo+etoposide/carboplatin/atezolizumab
arm group label: trilaciclib+etoposide/carboplatin/atezolizumab
other name: VP-16
intervention type: Drug
intervention name: Atezolizumab
description: Atezolizumab IV
arm group label: placebo+etoposide/carboplatin/atezolizumab
arm group label: trilaciclib+etoposide/carboplatin/atezolizumab
other name: Tecentriq
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Contact
role: Study Director
affiliation: G1 Therapeutics, Inc.
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country: Bulgaria
country: Estonia
country: France
country: Latvia
country: Spain
country: Ukraine
country: United States
citation: Daniel D, Kuchava V, Bondarenko I, Ivashchuk O, Reddy S, Jaal J, Kudaba I, Hart L, Matitashvili A, Pritchett Y, Morris SR, Sorrentino JA, Antal JM, Goldschmidt J. Trilaciclib prior to chemotherapy and atezolizumab in patients with newly diagnosed extensive-stage small cell lung cancer: A multicentre, randomised, double-blind, placebo-controlled Phase II trial. Int J Cancer. 2020 Dec 21;148(10):2557-70. doi: 10.1002/ijc.33453. Online ahead of print.
PMID: 33348420
citation: Weiss J, Goldschmidt J, Andric Z, Dragnev KH, Gwaltney C, Skaltsa K, Pritchett Y, Antal JM, Morris SR, Daniel D. Effects of Trilaciclib on Chemotherapy-Induced Myelosuppression and Patient-Reported Outcomes in Patients with Extensive-Stage Small Cell Lung Cancer: Pooled Results from Three Phase II Randomized, Double-Blind, Placebo-Controlled Studies. Clin Lung Cancer. 2021 Sep;22(5):449-460. doi: 10.1016/j.cllc.2021.03.010. Epub 2021 Mar 26.
PMID: 33895103
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Small Cell Lung Carcinoma
mesh term: Carboplatin
mesh term: Etoposide
mesh term: Atezolizumab
sharing ipd: No
provided document: 
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participant flow: 
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outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Limitation of the trial is small numbers of subjects, since it is a Phase 2 clinical trial.
Small sample size may have reduced the ability to observe statistically significant treatment effects on secondary myelopreservation measures (i.e. occurrence of FN AEs, infections and antibiotics usage).
point of contact: 