<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/NCT04426825</url>
  </required_header>
  <id_info>
    <org_study_id>ML41256</org_study_id>
    <nct_id>NCT04426825</nct_id>
  </id_info>
  <brief_title>A Study of Atezolizumab in Combination With Bevacizumab in Patients With EGFR Mutation Positive Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer</brief_title>
  <official_title>A Single Arm, Phase II Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Bevacizumab in Patients With EGFR Mutation Positive Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer Pretreated With Epidermal Growth Factor Receptor Tyrosine-Kinase Inhibitors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label, single-arm, phase II, multicenter study designed to evaluated the&#xD;
      efficacy and safety of atezolizumab in combination with bevacizumab in PD-L1-selected&#xD;
      patients with Stage IIIB-IV Non-Squamous NSCLC harbored EGFR mutation after EGFR TKI therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 9, 2020</start_date>
  <completion_date type="Actual">February 10, 2023</completion_date>
  <primary_completion_date type="Actual">January 19, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>Baseline up to approximately 10 months</time_frame>
    <description>Objective response rate (ORR) is defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions &gt;=4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of Objective Response (DOR)</measure>
    <time_frame>Baseline up to approximately 3 years</time_frame>
    <description>Duration of objective response (DOR) is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause whichever occurs first, as determined by the investigator according to RECIST v1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Response (TTR)</measure>
    <time_frame>Baseline up to approximately 3 years</time_frame>
    <description>Time to response (TTR) is defined as the time from the start of the treatment to the first objective tumor response observed for participants who achieved CR or PR, as determined by the investigator according to RECIST v1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate (DCR)</measure>
    <time_frame>Baseline up to approximately 3 years</time_frame>
    <description>Disease control rate (DCR) is defined as the proportion of participants who have a best overall response of CR or PR or stable disease (SD), as determined by the investigator according to RECIST v1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Baseline until death due to any cause (up to approximately 3 years)</time_frame>
    <description>Overall survival (OS) after enrollment is defined as the time from enrollment to death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>Baseline up to approximately 3 years</time_frame>
    <description>Progression-free survival (PFS) is defined as the time from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined by the investigator according to RECIST v1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PFS Rate at 6 and 12 Months</measure>
    <time_frame>Baseline to 6 months and 12 months</time_frame>
    <description>PFS rate at 6 and 12 months is defined as the percentage of participants who have not experienced disease progression or death from any cause at 6 and 12 months, as determined by the investigator according to RECIST v1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS Rate at 1 and 2 Years</measure>
    <time_frame>Baseline to 1 and 2 Years</time_frame>
    <description>OS rate at 1 and 2 years is defined as the percentage of participants who have not experienced death from any cause at 1 and 2 years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Adverse Events</measure>
    <time_frame>Baseline up to approximately 2 years</time_frame>
    <description>Percentage of participants with adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Serious and Non-Serious Immune-Mediated Adverse Events (irAEs)</measure>
    <time_frame>Baseline up to approximately 2 years</time_frame>
    <description>Percentage of serious and non-serious immune-mediated adverse events related to atezolizumab treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR) According to iRECIST</measure>
    <time_frame>Baseline up to approximately 3 years</time_frame>
    <description>Objective response rate (ORR) is defined as the proportion of participants with a complete response (CR) or partial response (PR) on two consecutive occasions ≥4 weeks apart, as determined by the investigator according to Modified RECIST v1.1 (iRECIST).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate (DCR) According to iRECIST</measure>
    <time_frame>Baseline up to approximately 3 years</time_frame>
    <description>Disease control rate (DCR) is defined as the proportion of participants who have a best overall response of CR or PR or stable disease (SD), as determined by the investigator according to modified RECIST v1.1 (iRECIST).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Objective Response (DOR) According to iRECIST</measure>
    <time_frame>Baseline up to approximately 3 years</time_frame>
    <description>Duration of objective response (DOR) is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause whichever occurs first, as determined by the investigator according to modified RECIST v1.1 (iRECIST).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS) According to iRECIST</measure>
    <time_frame>Baseline up to approximately 3 years</time_frame>
    <description>Progression-free survival (PFS) is defined as the time from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined by the investigator according to modified RECIST v1.1 (iRECIST).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS) Rate at 12 Months According to iRECIST</measure>
    <time_frame>Baseline up to approximately 12 months</time_frame>
    <description>Progression-free survival (PFS) rate is defined as the time from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first at 12 months, as determined by the investigator according to modified RECIST v1.1 (iRECIST).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Deterioation (TTD) Using EORTC</measure>
    <time_frame>Baselsine up to approximately 1 year</time_frame>
    <description>Time to deterioration (TTD) using European Organization for Research and treatment of Cancer (EORTC) Quality-of-life Questionnaire Core 30 (QLQ C30) and its Lung Cancer Module (QLQ LC13) is defined as the time from baseline to the first time the patient's score shows a ≥10 points increase above baseline in any of the following EORTC-transformed symptom subscale scores (whichever occurs first): cough, dyspnea (single item), dyspnea (multi-item subscale), chest pain, or arm/shoulder pain, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Health-Related Quality of Life (HRQoL), Lung Cancer Related Symptoms and Health Status</measure>
    <time_frame>Baseline up to approximately 1 year</time_frame>
    <description>Change from baseline in HRQoL, lung cancer related symptoms, and health status will be measured using the European Organization for Research and treatment of Cancer (EORTC) Quality-of-life Questionnaire Core 30 (QLQ C30) and its Lung Cancer Module (QLQ LC13).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Carcinoma, Non-Small-Cell Lung</condition>
  <arm_group>
    <arm_group_label>Atezolizumab plus Bevacizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atezolizumab</intervention_name>
    <description>Atezolizumab will be administered at a dose of 1200 mg intravenously on Day 1 of each 21-day cycle.</description>
    <arm_group_label>Atezolizumab plus Bevacizumab</arm_group_label>
    <other_name>Tecentriq</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bevacizumab</intervention_name>
    <description>Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.</description>
    <arm_group_label>Atezolizumab plus Bevacizumab</arm_group_label>
    <other_name>Avastin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Life expectancy ≥ 10 months&#xD;
&#xD;
          -  Histologically or cytologically confirmed stage IIIB, IIIC, or IV non-squamous NSCLC.&#xD;
             Patients with tumors of mixed histology are eligible if the major histological&#xD;
             component appears to be non-squamous.&#xD;
&#xD;
          -  No prior treatment for Stage IIIB, IIIC, or IV non-squamous NSCLC, with the following&#xD;
             exceptions:&#xD;
&#xD;
        Patients with a sensitizing mutation in the EGFR gene must have experienced disease&#xD;
        progression or were intolerant to treatment with one or more EGFR TKIs. Patients who have&#xD;
        progressed on or were intolerant to first-line osimertinib or other thirdgeneration EGFR&#xD;
        TKIs are eligible.&#xD;
&#xD;
        Patients who have progressed on or were intolerant to first- or second-generation EGFR&#xD;
        TKIs, and who have no evidence of the EGFR T790M mutation after TKI therapy are eligible.&#xD;
&#xD;
        Patients who have progressed on or were intolerant to first- or second-generation EGFR TKIs&#xD;
        and who have evidence of the T790M mutation must have also progressed on or were intolerant&#xD;
        to osimertinib to be eligible.&#xD;
&#xD;
          -  TKIs approved for treatment of NSCLC discontinued &gt;7 days prior to enrollment.&#xD;
&#xD;
          -  Measurable disease per RECIST v1.1. PD-L1 expression of ≥1% as documented through&#xD;
             central testing of a representative tumor tissue specimen either from previously&#xD;
             obtained archival tumor tissue or tissue obtained from a biopsy at screening&#xD;
&#xD;
          -  ECOG Performance Status of 0-1&#xD;
&#xD;
          -  Adequate hematologic and end-organ function&#xD;
&#xD;
          -  Negative HIV test at screening&#xD;
&#xD;
          -  Negative hepatitis B surface antigen (HBsAg) test at screening&#xD;
&#xD;
          -  Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total&#xD;
             HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening. The&#xD;
             HBV DNA test will be performed only for patients who have a positive total HBcAb test.&#xD;
&#xD;
          -  Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody&#xD;
             test followed by a negative HCV RNA test at screening. The HCV RNA test will be&#xD;
             performed only for patients who have a positive HCV antibody test.&#xD;
&#xD;
          -  For women of childbearing potential: agreement to remain abstinent (refrain from&#xD;
             heterosexual intercourse) or use contraceptive methods, and agreement to refrain from&#xD;
             donating eggs.&#xD;
&#xD;
          -  For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use&#xD;
             a condom, and agreement to refrain from donating sperm.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Symptomatic, untreated, or actively progressing central nervous system (CNS)&#xD;
             metastases as determined by CT or MRI evaluation during screening and prior&#xD;
             radiographic assessments&#xD;
&#xD;
          -  History of leptomeningeal disease&#xD;
&#xD;
          -  Prior chemotherapy or other systemic therapy for stage IIIB, IIIC, or IV disease&#xD;
&#xD;
          -  Active or history of autoimmune disease or immune deficiency&#xD;
&#xD;
          -  History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced&#xD;
             pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening&#xD;
             chest computed tomography (CT) scan&#xD;
&#xD;
          -  Active tuberculosis&#xD;
&#xD;
          -  Significant cardiovascular disease within 3 months prior to initiation of study&#xD;
             treatment, unstable arrhythmia, or unstable angina&#xD;
&#xD;
          -  History of malignancy other than NSCLC within 5 years prior to screening, with the&#xD;
             exception of malignancies with a negligible risk of metastasis or death&#xD;
&#xD;
          -  Prior allogeneic stem cell or solid organ transplantation&#xD;
&#xD;
          -  Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study&#xD;
             treatment, or anticipation of need for such a vaccine during atezolizumab treatment or&#xD;
             within 5 months after the final dose of atezolizumab&#xD;
&#xD;
          -  Current treatment with anti-viral therapy for HBV&#xD;
&#xD;
          -  Treatment with investigational therapy within 28 days prior to initiation of study&#xD;
             treatment&#xD;
&#xD;
          -  Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including&#xD;
             anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies&#xD;
&#xD;
          -  Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the&#xD;
             drug (whichever is longer) prior to initiation of study treatment&#xD;
&#xD;
          -  Treatment with systemic immunosuppressive medication within 2 weeks prior to&#xD;
             initiation of study treatment, or anticipation of need for systemic immunosuppressive&#xD;
             medication during study treatment&#xD;
&#xD;
          -  History of severe allergic anaphylactic reactions to chimeric or humanized antibodies&#xD;
             or fusion proteins&#xD;
&#xD;
          -  Known hypersensitivity to Chinese hamster ovary cell products or to any component of&#xD;
             the atezolizumab or bevacizumab formulations&#xD;
&#xD;
          -  Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment&#xD;
             or within 5 months after the final dose of atezolizumab, 6 months after the final dose&#xD;
             of bevacizumab&#xD;
&#xD;
          -  Prior history of hypertensive crisis or hypertensive encephalopathy&#xD;
&#xD;
          -  Significant vascular disease within 6 months prior to initiation of study treatment&#xD;
&#xD;
          -  History of Grade ≥ 2 hemoptysis within 1 month prior to enrollment&#xD;
&#xD;
          -  Evidence of bleeding diathesis or coagulopathy. Current or recent use of aspirin,&#xD;
             clopidogrel or treatment with dipyramidole, ticlopidine, or cilostazol&#xD;
&#xD;
          -  Current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for&#xD;
             therapeutic purposes that has not been stable for &gt; 2 weeks prior to enrollment&#xD;
&#xD;
          -  History of stroke or transient ischemic attack within 6 months prior to enrollment&#xD;
&#xD;
          -  Core biopsy or other minor surgical procedure, excluding placement of a vascular&#xD;
             access device, within 7 days prior to the first dose of bevacizumab&#xD;
&#xD;
          -  History of abdominal or tracheosphageal fistula or gastrointestinal perforation within&#xD;
             6 months prior to enrollment&#xD;
&#xD;
          -  History of intra-abdominal inflammatory process within 6 months prior to initiation of&#xD;
             study treatment, including but not limited to active peptic ulcer disease,&#xD;
             diverticulitis,or colitis&#xD;
&#xD;
          -  Clinical signs of gastrointestinal obstruction or requirement for routine parenteral&#xD;
             hydration, parenteral nutrition, or tube feeding&#xD;
&#xD;
          -  Evidence of abdominal free air not explained by paracentesis or recent surgical&#xD;
             procedure&#xD;
&#xD;
          -  Proteinuria&#xD;
&#xD;
          -  Clear tumor infiltration into the thoracic great vessels is seen on imaging&#xD;
&#xD;
          -  Clear cavitation of pulmonary lesions is seen on imaging&#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 Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Hospital; Internal Medicine-Oncology</name>
      <address>
        <city>Beijing</city>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Chest Hospital; Oncology Department</name>
      <address>
        <city>Beijing</city>
        <zip>101149</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Hospital, Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Yet-sen University Cancer Center</name>
      <address>
        <city>Guangzhou City</city>
        <zip>510663</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department</name>
      <address>
        <city>Hangzhou City</city>
        <zip>310022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harbin Medical University Cancer Hospital</name>
      <address>
        <city>Harbin</city>
        <zip>150081</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shandong Cancer Hospital</name>
      <address>
        <city>Jinan</city>
        <zip>250117</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangxi Cancer Hospital of Guangxi Medical University</name>
      <address>
        <city>Nanning</city>
        <zip>530021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Affiliated Hospital of Medical College Qingdao University</name>
      <address>
        <city>Qingdao</city>
        <zip>266000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <results_first_submitted>January 6, 2023</results_first_submitted>
  <results_first_submitted_qc>April 11, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">April 13, 2023</results_first_posted>
  <last_update_submitted>April 11, 2023</last_update_submitted>
  <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bevacizumab</mesh_term>
    <mesh_term>Atezolizumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).</ipd_description>
  </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>January 11, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/25/NCT04426825/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</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>August 19, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/25/NCT04426825/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study was conducted at multiple investigational sites in China</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Atezolizumab Plus Bevacizumab</title>
          <description>Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Continuing on study</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Atezolizumab Plus Bevacizumab</title>
          <description>Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="23"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="59.8" spread="10.07"/>
                  </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_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking History</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Never</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Current</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Previous</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Objective Response Rate (ORR)</title>
        <description>Objective response rate (ORR) is defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions &gt;=4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).</description>
        <time_frame>Baseline up to approximately 10 months</time_frame>
        <population>The evaluable population included all enrolled participants who received any amount of study treatment, had baseline and at least one post-baseline efficacy measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Atezolizumab Plus Bevacizumab</title>
            <description>Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate (ORR)</title>
          <description>Objective response rate (ORR) is defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions &gt;=4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).</description>
          <population>The evaluable population included all enrolled participants who received any amount of study treatment, had baseline and at least one post-baseline efficacy measurement.</population>
          <units>Percentage of Participants</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="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.2" lower_limit="5.19" upper_limit="40.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Objective Response (DOR)</title>
        <description>Duration of objective response (DOR) is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause whichever occurs first, as determined by the investigator according to RECIST v1.1.</description>
        <time_frame>Baseline up to approximately 3 years</time_frame>
        <posting_date>02/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Response (TTR)</title>
        <description>Time to response (TTR) is defined as the time from the start of the treatment to the first objective tumor response observed for participants who achieved CR or PR, as determined by the investigator according to RECIST v1.1.</description>
        <time_frame>Baseline up to approximately 3 years</time_frame>
        <posting_date>02/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Control Rate (DCR)</title>
        <description>Disease control rate (DCR) is defined as the proportion of participants who have a best overall response of CR or PR or stable disease (SD), as determined by the investigator according to RECIST v1.1.</description>
        <time_frame>Baseline up to approximately 3 years</time_frame>
        <posting_date>02/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>Overall survival (OS) after enrollment is defined as the time from enrollment to death from any cause.</description>
        <time_frame>Baseline until death due to any cause (up to approximately 3 years)</time_frame>
        <posting_date>02/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-Free Survival (PFS)</title>
        <description>Progression-free survival (PFS) is defined as the time from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined by the investigator according to RECIST v1.1.</description>
        <time_frame>Baseline up to approximately 3 years</time_frame>
        <posting_date>02/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PFS Rate at 6 and 12 Months</title>
        <description>PFS rate at 6 and 12 months is defined as the percentage of participants who have not experienced disease progression or death from any cause at 6 and 12 months, as determined by the investigator according to RECIST v1.1.</description>
        <time_frame>Baseline to 6 months and 12 months</time_frame>
        <population>The FAS population included all enrolled participants who received any amount of at least one dose of any study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Atezolizumab Plus Bevacizumab</title>
            <description>Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.</description>
          </group>
        </group_list>
        <measure>
          <title>PFS Rate at 6 and 12 Months</title>
          <description>PFS rate at 6 and 12 months is defined as the percentage of participants who have not experienced disease progression or death from any cause at 6 and 12 months, as determined by the investigator according to RECIST v1.1.</description>
          <population>The FAS population included all enrolled participants who received any amount of at least one dose of any study treatment.</population>
          <units>Percentage of participants</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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.36" lower_limit="2.84" upper_limit="34.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">NA = not estimable; could not be calculated due to too few events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>OS Rate at 1 and 2 Years</title>
        <description>OS rate at 1 and 2 years is defined as the percentage of participants who have not experienced death from any cause at 1 and 2 years.</description>
        <time_frame>Baseline to 1 and 2 Years</time_frame>
        <posting_date>02/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Adverse Events</title>
        <description>Percentage of participants with adverse events.</description>
        <time_frame>Baseline up to approximately 2 years</time_frame>
        <population>The safety population is defined as all enrolled participants who received any amount of at least one dose of any study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Atezolizumab Plus Bevacizumab</title>
            <description>Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Adverse Events</title>
          <description>Percentage of participants with adverse events.</description>
          <population>The safety population is defined as all enrolled participants who received any amount of at least one dose of any study 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="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Serious and Non-Serious Immune-Mediated Adverse Events (irAEs)</title>
        <description>Percentage of serious and non-serious immune-mediated adverse events related to atezolizumab treatment.</description>
        <time_frame>Baseline up to approximately 2 years</time_frame>
        <population>The safety population is defined as all enrolled participants who received any amount of at least one dose of any study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Atezolizumab Plus Bevacizumab</title>
            <description>Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Serious and Non-Serious Immune-Mediated Adverse Events (irAEs)</title>
          <description>Percentage of serious and non-serious immune-mediated adverse events related to atezolizumab treatment.</description>
          <population>The safety population is defined as all enrolled participants who received any amount of at least one dose of any study 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="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Response Rate (ORR) According to iRECIST</title>
        <description>Objective response rate (ORR) is defined as the proportion of participants with a complete response (CR) or partial response (PR) on two consecutive occasions ≥4 weeks apart, as determined by the investigator according to Modified RECIST v1.1 (iRECIST).</description>
        <time_frame>Baseline up to approximately 3 years</time_frame>
        <posting_date>02/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Control Rate (DCR) According to iRECIST</title>
        <description>Disease control rate (DCR) is defined as the proportion of participants who have a best overall response of CR or PR or stable disease (SD), as determined by the investigator according to modified RECIST v1.1 (iRECIST).</description>
        <time_frame>Baseline up to approximately 3 years</time_frame>
        <posting_date>02/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Objective Response (DOR) According to iRECIST</title>
        <description>Duration of objective response (DOR) is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause whichever occurs first, as determined by the investigator according to modified RECIST v1.1 (iRECIST).</description>
        <time_frame>Baseline up to approximately 3 years</time_frame>
        <posting_date>02/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-Free Survival (PFS) According to iRECIST</title>
        <description>Progression-free survival (PFS) is defined as the time from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined by the investigator according to modified RECIST v1.1 (iRECIST).</description>
        <time_frame>Baseline up to approximately 3 years</time_frame>
        <posting_date>02/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-Free Survival (PFS) Rate at 12 Months According to iRECIST</title>
        <description>Progression-free survival (PFS) rate is defined as the time from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first at 12 months, as determined by the investigator according to modified RECIST v1.1 (iRECIST).</description>
        <time_frame>Baseline up to approximately 12 months</time_frame>
        <posting_date>02/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Deterioation (TTD) Using EORTC</title>
        <description>Time to deterioration (TTD) using European Organization for Research and treatment of Cancer (EORTC) Quality-of-life Questionnaire Core 30 (QLQ C30) and its Lung Cancer Module (QLQ LC13) is defined as the time from baseline to the first time the patient's score shows a ≥10 points increase above baseline in any of the following EORTC-transformed symptom subscale scores (whichever occurs first): cough, dyspnea (single item), dyspnea (multi-item subscale), chest pain, or arm/shoulder pain, whichever occurs first.</description>
        <time_frame>Baselsine up to approximately 1 year</time_frame>
        <posting_date>02/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Health-Related Quality of Life (HRQoL), Lung Cancer Related Symptoms and Health Status</title>
        <description>Change from baseline in HRQoL, lung cancer related symptoms, and health status will be measured using the European Organization for Research and treatment of Cancer (EORTC) Quality-of-life Questionnaire Core 30 (QLQ C30) and its Lung Cancer Module (QLQ LC13).</description>
        <time_frame>Baseline up to approximately 1 year</time_frame>
        <posting_date>02/2024</posting_date>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to approximately 2 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Atezolizumab Plus Bevacizumab</title>
          <description>Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.1</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="17" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Left ventricular dysfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 24.1</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="23" subjects_at_risk="23"/>
              </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="7" subjects_affected="5" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="10" subjects_affected="6" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Blood thyroid stimulating hormone increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="10" subjects_affected="5" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Urinary occult blood positive</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Thyroxine free decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>White blood cells urine positive</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="5" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Hypertriglyceridaemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="23"/>
              </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="3" subjects_affected="2" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" events="10" subjects_affected="7" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="23"/>
              </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>
      <restrictive_agreement>The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Communications</name_or_title>
      <organization>Hoffmann-La Roche</organization>
      <phone>800-821-8590</phone>
      <email>genentech@druginfo.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/NCT04426825
org study id: ML41256
nct id: NCT04426825
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This is an open-label, single-arm, phase II, multicenter study designed to evaluated the
      efficacy and safety of atezolizumab in combination with bevacizumab in PD-L1-selected
      patients with Stage IIIB-IV Non-Squamous NSCLC harbored EGFR mutation after EGFR TKI therapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response Rate (ORR)
time frame: Baseline up to approximately 10 months
description: Objective response rate (ORR) is defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions >=4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
measure: Duration of Objective Response (DOR)
time frame: Baseline up to approximately 3 years
description: Duration of objective response (DOR) is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause whichever occurs first, as determined by the investigator according to RECIST v1.1.
measure: Time to Response (TTR)
time frame: Baseline up to approximately 3 years
description: Time to response (TTR) is defined as the time from the start of the treatment to the first objective tumor response observed for participants who achieved CR or PR, as determined by the investigator according to RECIST v1.1.
measure: Disease Control Rate (DCR)
time frame: Baseline up to approximately 3 years
description: Disease control rate (DCR) is defined as the proportion of participants who have a best overall response of CR or PR or stable disease (SD), as determined by the investigator according to RECIST v1.1.
measure: Overall Survival (OS)
time frame: Baseline until death due to any cause (up to approximately 3 years)
description: Overall survival (OS) after enrollment is defined as the time from enrollment to death from any cause.
measure: Progression-Free Survival (PFS)
time frame: Baseline up to approximately 3 years
description: Progression-free survival (PFS) is defined as the time from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined by the investigator according to RECIST v1.1.
measure: PFS Rate at 6 and 12 Months
time frame: Baseline to 6 months and 12 months
description: PFS rate at 6 and 12 months is defined as the percentage of participants who have not experienced disease progression or death from any cause at 6 and 12 months, as determined by the investigator according to RECIST v1.1.
measure: OS Rate at 1 and 2 Years
time frame: Baseline to 1 and 2 Years
description: OS rate at 1 and 2 years is defined as the percentage of participants who have not experienced death from any cause at 1 and 2 years.
measure: Percentage of Participants With Adverse Events
time frame: Baseline up to approximately 2 years
description: Percentage of participants with adverse events.
measure: Percentage of Participants With Serious and Non-Serious Immune-Mediated Adverse Events (irAEs)
time frame: Baseline up to approximately 2 years
description: Percentage of serious and non-serious immune-mediated adverse events related to atezolizumab treatment.
measure: Objective Response Rate (ORR) According to iRECIST
time frame: Baseline up to approximately 3 years
description: Objective response rate (ORR) is defined as the proportion of participants with a complete response (CR) or partial response (PR) on two consecutive occasions ≥4 weeks apart, as determined by the investigator according to Modified RECIST v1.1 (iRECIST).
measure: Disease Control Rate (DCR) According to iRECIST
time frame: Baseline up to approximately 3 years
description: Disease control rate (DCR) is defined as the proportion of participants who have a best overall response of CR or PR or stable disease (SD), as determined by the investigator according to modified RECIST v1.1 (iRECIST).
measure: Duration of Objective Response (DOR) According to iRECIST
time frame: Baseline up to approximately 3 years
description: Duration of objective response (DOR) is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause whichever occurs first, as determined by the investigator according to modified RECIST v1.1 (iRECIST).
measure: Progression-Free Survival (PFS) According to iRECIST
time frame: Baseline up to approximately 3 years
description: Progression-free survival (PFS) is defined as the time from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined by the investigator according to modified RECIST v1.1 (iRECIST).
measure: Progression-Free Survival (PFS) Rate at 12 Months According to iRECIST
time frame: Baseline up to approximately 12 months
description: Progression-free survival (PFS) rate is defined as the time from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first at 12 months, as determined by the investigator according to modified RECIST v1.1 (iRECIST).
measure: Time to Deterioation (TTD) Using EORTC
time frame: Baselsine up to approximately 1 year
description: Time to deterioration (TTD) using European Organization for Research and treatment of Cancer (EORTC) Quality-of-life Questionnaire Core 30 (QLQ C30) and its Lung Cancer Module (QLQ LC13) is defined as the time from baseline to the first time the patient's score shows a ≥10 points increase above baseline in any of the following EORTC-transformed symptom subscale scores (whichever occurs first): cough, dyspnea (single item), dyspnea (multi-item subscale), chest pain, or arm/shoulder pain, whichever occurs first.
measure: Change From Baseline in Health-Related Quality of Life (HRQoL), Lung Cancer Related Symptoms and Health Status
time frame: Baseline up to approximately 1 year
description: Change from baseline in HRQoL, lung cancer related symptoms, and health status will be measured using the European Organization for Research and treatment of Cancer (EORTC) Quality-of-life Questionnaire Core 30 (QLQ C30) and its Lung Cancer Module (QLQ LC13).
arm group label: Atezolizumab plus Bevacizumab
arm group type: Experimental
description: Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.
intervention type: Drug
intervention name: Atezolizumab
description: Atezolizumab will be administered at a dose of 1200 mg intravenously on Day 1 of each 21-day cycle.
arm group label: Atezolizumab plus Bevacizumab
other name: Tecentriq
intervention type: Drug
intervention name: Bevacizumab
description: Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.
arm group label: Atezolizumab plus Bevacizumab
other name: Avastin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
facility: 
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facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Bevacizumab
mesh term: Atezolizumab
sharing ipd: Yes
ipd description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 