<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/NCT04471428</url>
  </required_header>
  <id_info>
    <org_study_id>GO41892</org_study_id>
    <nct_id>NCT04471428</nct_id>
  </id_info>
  <brief_title>Study of Atezolizumab in Combination With Cabozantinib Versus Docetaxel in Patients With Metastatic Non-Small Cell Lung Cancer Previously Treated With an Anti-PD-L1/PD-1 Antibody and Platinum-Containing Chemotherapy</brief_title>
  <acronym>CONTACT-01</acronym>
  <official_title>A Phase III, Multicenter, Randomized, Open-Label, Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Atezolizumab Given in Combination With Cabozantinib Versus Docetaxel Monotherapy in Patients With Metastatic Non-Small Lung Cancer Previously Treated With an Anti-PD-L1/PD-1 Antibody and Platinum-Containing Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Exelixis</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Hoffmann-La Roche</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 is a Phase III, multicenter, randomized, open-label study designed to evaluate the&#xD;
      efficacy, safety, and pharmacokinetics of atezolizumab given in combination with cabozantinib&#xD;
      compared with docetaxel monotherapy in patients with metastatic NSCLC, with no sensitizing&#xD;
      EGFR mutation or ALK translocation, who have progressed following treatment with&#xD;
      platinum-containing chemotherapy and anti-PD-L1/PD-1 antibody, administered concurrently or&#xD;
      sequentially.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Anticipated">February 28, 2024</completion_date>
  <primary_completion_date type="Actual">September 28, 2022</primary_completion_date>
  <phase>Phase 3</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to approximately 43 months</time_frame>
    <description>Overall survival (OS) after randomization, defined as the time from randomization to death from any cause.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PFS, as Determined by Investigator</measure>
    <time_frame>Up to approximately 43 months</time_frame>
    <description>PFS after randomization, defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator according to RECIST v1.1, or death from any cause (whichever occurs first).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Confirmed Objective Response Rate (ORR), as Determined by Investigator</measure>
    <time_frame>Up to approximately 43 months</time_frame>
    <description>Confirmed objective response rate (ORR), defined as the proportion of participants with a complete or partial response on two consecutive occasions &gt;=4 weeks apart, as determined by the investigator according to RECIST v1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response (DOR), as Determined by Investigator</measure>
    <time_frame>Up to approximately 43 months</time_frame>
    <description>Duration of response (DOR) for participants with confirmed ORR, defined as the time from the first occurrence of a documented objective response to disease progression, as determined by the investigator according to RECIST v1.1, or death from any cause (whichever occurs first).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Confirmed Deterioration in Patient-Reported Physical Functioning (PF)</measure>
    <time_frame>Up to approximately 43 months</time_frame>
    <description>Time to confirmed deterioration in patient-reported physical functioning (PF) as measured by the corresponding scores from the European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life-Core 30 (QLQ-C30).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Confirmed Deterioration in Patient-Reported Global Health Status (GHS)</measure>
    <time_frame>Up to approximately 43 months</time_frame>
    <description>Time to confirmed deterioration in patient-reported Global Health Status (GHS) as measured by the corresponding scores from the European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life-Core 30 (QLQ-C30).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PFS Rates Assessed by Investigator</measure>
    <time_frame>6 months and 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS Rates</measure>
    <time_frame>1 and 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Adverse Events</measure>
    <time_frame>Up to approximately 43 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum Serum Concentration (Cmin) of Atezolizumab</measure>
    <time_frame>Predose and postdose on Day 1 of Cycle 1; and Predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (each cycle is 21 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Serum Concentration (Cmax) of Atezolizumab</measure>
    <time_frame>Predose and postdose on Day 1 of Cycle 1; and Predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (each cycle is 21 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum Serum Concentration (Cmin) of Cabozantinib</measure>
    <time_frame>Predose on Day 1 of Cycles 1, 2, 3, 4, and 5 (each cycle is 21 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Serum Concentration (Cmax) of Cabozantinib</measure>
    <time_frame>Predose on Day 1 of Cycles 1, 2, 3, 4, and 5 (each cycle is 21 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Anti-Drug Antibodies (ADAs) to Atezolizumab</measure>
    <time_frame>Predose on Day 1 of Cycle 1 (each cycle is 21 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of ADAs to Atezolizumab After Treatment</measure>
    <time_frame>Predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 (each cycle is 21 days)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">366</enrollment>
  <condition>Carcinoma, Non-Small-Cell Lung</condition>
  <arm_group>
    <arm_group_label>Atezolizumab + Cabozantinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive atezolizumab on Day 1 of each 21-day cycle and cabozantinib orally once daily on days 1-21 of each cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Docetaxel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive docetaxel on Day 1 of each 21-day cycle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cabozantinib</intervention_name>
    <description>Cabozantinib will be administered orally, once daily at a dose of 40 mg on Days 1-21 of each cycle.</description>
    <arm_group_label>Atezolizumab + Cabozantinib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atezolizumab</intervention_name>
    <description>Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.</description>
    <arm_group_label>Atezolizumab + Cabozantinib</arm_group_label>
    <other_name>Tecentriq</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel</intervention_name>
    <description>Docetaxel will be administered by IV infusion at a starting dose of 75mg/m2 on Day 1 of each 21-day cycle.</description>
    <arm_group_label>Docetaxel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically confirmed metastatic NSCLC&#xD;
&#xD;
          -  Documented radiographic disease progression during or following treatment with&#xD;
             platinum-containing chemotherapy and anti-PD-L1/PD-1 antibody, administered&#xD;
             concurrently or sequentially for metastatic NSCLC&#xD;
&#xD;
          -  Measurable disease per RECIST v1.1 outside CNS as assessed by investigator&#xD;
&#xD;
          -  Known PD-L1 status or availability of tumor tissue for central PD-L1 testing&#xD;
&#xD;
          -  ECOG Performance Status score of 0 or 1&#xD;
&#xD;
          -  Recovery to baseline or Grade &lt;=1 NCI CTCAE v5.0 from toxicities related to any prior&#xD;
             treatments, unless adverse events are clinically nonsignificant and/or stable on&#xD;
             supportive therapy in the opinion of the investigator&#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&#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&#xD;
&#xD;
          -  For women of childbearing potential: agreement to remain abstinent (refrain from&#xD;
             heterosexual intercourse) or use contraception, and agreement to refrain from donating&#xD;
             eggs,&#xD;
&#xD;
          -  For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use&#xD;
             contraceptive methods, and agreement to refrain from donating sperm.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior therapy with the following agents for NSCLC: Cabozantinib, Docetaxel,&#xD;
             Combination of an anti-PD-L1/PD-1 antibody concurrently with a vascular endothelial&#xD;
             growth factor (VEGF)R targeting tyrosine kinase inhibitor (TKI)&#xD;
&#xD;
          -  Treatment with investigational therapy within 28 days prior to initiation of study&#xD;
             treatment&#xD;
&#xD;
          -  Documentation of known sensitizing mutation in the EGFR gene or ALK fusion oncogene&#xD;
&#xD;
          -  Patients with known ROS1 rearrangements, BRAF V600E mutations, or other actionable&#xD;
             oncogenes with approved therapies if available&#xD;
&#xD;
          -  Symptomatic, untreated, or actively progressing CNS metastases&#xD;
&#xD;
          -  History of leptomeningeal disease&#xD;
&#xD;
          -  Uncontrolled tumor-related pain&#xD;
&#xD;
          -  Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent&#xD;
             drainage procedures (more frequently than once monthly)&#xD;
&#xD;
          -  Severe hepatic impairment&#xD;
&#xD;
          -  Uncontrolled or symptomatic hypercalcemia&#xD;
&#xD;
          -  Any other active malignancy at the time of initiation of study treatment or diagnosis&#xD;
             of another malignancy within 3 years prior to initiation of study treatment that&#xD;
             requires active treatment, except for locally curable cancers that have been&#xD;
             apparently cured, such as basal or squamous cell skin cancer, incidental prostate&#xD;
             cancer, or carcinoma in situ of the prostate, cervix, or breast&#xD;
&#xD;
          -  Stroke, transient ischemic attack, myocardial infarction or other symptomatic ischemic&#xD;
             events within 6 months of initiation of study treatment&#xD;
&#xD;
          -  Significant vascular disease within 6 months of initiation of study treatment&#xD;
&#xD;
          -  Significant cardiovascular disease within 3 months prior to initiation of study&#xD;
             treatment, unstable arrhythmia, or unstable angina&#xD;
&#xD;
          -  Active tuberculosis&#xD;
&#xD;
          -  Severe infection within 4 weeks prior to initiation of study treatment, including, but&#xD;
             not limited to, hospitalization for complications of infection, bacteremia, or severe&#xD;
             pneumonia, or any active infection that, in the opinion on the investigator, could&#xD;
             impact patient safety&#xD;
&#xD;
          -  Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation&#xD;
             of study treatment&#xD;
&#xD;
          -  Current treatment with anti-viral therapy for HBV&#xD;
&#xD;
          -  Major surgical procedure, other than for diagnosis within 4 weeks prior to initiation&#xD;
             of study treatment, or anticipation of need for a major surgical procedure during the&#xD;
             study&#xD;
&#xD;
          -  Pregnant or lactating females, or intention of becoming pregnant during the treatment&#xD;
             with atezolizumab in combination with cabozantinib in the experimental arm or during&#xD;
             the treatment with docetaxel in the control arm, or within 5 months after the final&#xD;
             dose of atezolizumab and/or 4 months after the final dose of cabozantinib, whichever&#xD;
             is later.&#xD;
&#xD;
          -  Ongoing Grade &gt;= 2 sensory or motor neuropathy&#xD;
&#xD;
          -  Active or history of autoimmune disease or immune deficiency, including, but not&#xD;
             limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus&#xD;
             erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid&#xD;
             antibody syndrome, granulomatosis with polyangiitis, Sjögren syndrome, Guillain-Barré&#xD;
             syndrome, or multiple sclerosis with the following exceptions: Patients with a history&#xD;
             of autoimmune-mediated hypothyroidism who are on thyroid replacement hormone are&#xD;
             eligible for the study. Patients with controlled Type 1 diabetes mellitus are eligible&#xD;
             for the study. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo&#xD;
             with dermatologic manifestations only are eligible for the study provided all of&#xD;
             following conditions are met: Rash must cover &lt; 10% of body surface area.&#xD;
&#xD;
          -  Pharmacologically uncompensated, symptomatic hypothyroidism&#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;
          -  Prior allogeneic stem cell or solid organ transplantation&#xD;
&#xD;
          -  Administration of a live, attenuated vaccine within 4 weeks prior to initiation of&#xD;
             study treatment or anticipation of need for such a vaccine during atezolizumab&#xD;
             treatment or within 5 months after the final dose of atezolizumab&#xD;
&#xD;
          -  Treatment with systemic immunostimulatory agents (including, but not limited to,&#xD;
             interferon and interleukin 2) within 4 weeks or 5 drug-elimination half-lives&#xD;
             (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, with the following exceptions: Patients who&#xD;
             received acute, low-dose systemic immunosuppressant medication or a one-time pulse&#xD;
             dose of systemic immunosuppressant medication are eligible for the study after Medical&#xD;
             Monitor confirmation has been obtained. Patients who received mineralocorticoids,&#xD;
             inhaled or low-dose systemic corticosteroids for COPD or asthma, or low-dose&#xD;
             corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for&#xD;
             the study.&#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 formulation&#xD;
&#xD;
          -  Known allergy or hypersensitivity to any component of the cabozantinib formulation&#xD;
&#xD;
          -  History of severe hypersensitivity to docetaxel or to other drugs formulated with&#xD;
             polysorbate 80&#xD;
&#xD;
          -  Concomitant anticoagulation with coumarin agents, direct thrombin inhibitor&#xD;
             dabigatran, direct factor Xa inhibitor betrixaban, or platelet inhibitors&#xD;
&#xD;
          -  History of risk factors for torsades de pointes&#xD;
&#xD;
          -  Corrected QT interval corrected through use of Fridericia's formula (QTcF) &gt; 480 ms&#xD;
             per ECG within 14 days before initiation of study treatment&#xD;
&#xD;
          -  Uncontrolled hypertension defined as systolic blood pressure &gt; 150 mm Hg or diastolic&#xD;
             BP &gt; 90 mm Hg despite optimal antihypertensive treatment&#xD;
&#xD;
          -  Tumors invading the GI-tract, active peptic ulcer disease, acute pancreatitis, acute&#xD;
             obstruction of the pancreatic or biliary duct, appendicitis, cholangitis,&#xD;
             cholecystitis, diverticulitis, gastric outlet obstruction, or inflammatory bowel&#xD;
             disease&#xD;
&#xD;
          -  Abdominal fistula, bowel obstruction, GI perforation, or intra-abdominal abscess&#xD;
             within 6 months before initiation of study treatment&#xD;
&#xD;
          -  Known cavitating pulmonary lesion(s) or known endobronchial disease manifestation&#xD;
&#xD;
          -  Lesions invading major pulmonary blood vessels&#xD;
&#xD;
          -  Clinically significant hematuria, hematemesis, hemoptysis of &gt; 0.5 teaspoon (2.5 mL)&#xD;
             of red blood, coagulopathy, or other history of significant bleeding within 3 months&#xD;
             before initiation of study treatment&#xD;
&#xD;
          -  Serious non-healing wound/ulcer/bone fracture&#xD;
&#xD;
          -  Malabsorption syndrome&#xD;
&#xD;
          -  Patients with rare hereditary problems of galactose intolerance, the Lapp lactase&#xD;
             deficiency, or glucose-galactose malabsorption are also excluded.&#xD;
&#xD;
          -  Requirement for hemodialysis or peritoneal dialysis&#xD;
&#xD;
          -  Inability to swallow tablets&#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>Stanford University</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente - San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sansum Clinic</name>
      <address>
        <city>Santa Barbara</city>
        <state>California</state>
        <zip>93105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Cancer Care Associates</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karmanos Cancer Center</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Oncology Hematology</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consultants in Medical Oncology and Hematology</name>
      <address>
        <city>Broomall</city>
        <state>Pennsylvania</state>
        <zip>19008</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charleston Oncology, P .A</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - Baylor Charles A. Sammons Cancer Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huntsman Cancer Institute at The University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Cancer Specialists (Fairfax) - USOR</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncology and Hematology Associates of Southwest Virginia, Inc.,-Blacksburg</name>
      <address>
        <city>Roanoke</city>
        <state>Virginia</state>
        <zip>24014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal North Shore Hospital; Oncology</name>
      <address>
        <city>St. Leonards</city>
        <state>New South Wales</state>
        <zip>2065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Townsville Hospital</name>
      <address>
        <city>Townsville</city>
        <state>Queensland</state>
        <zip>4810</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Flinders Medical Centre</name>
      <address>
        <city>Bedford Park</city>
        <state>South Australia</state>
        <zip>5042</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Hospital Olivia Newton John Cancer Centre</name>
      <address>
        <city>Heidelberg</city>
        <state>Victoria</state>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affinity Oncology</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordensklinikum Linz Elisabethinen</name>
      <address>
        <city>Linz</city>
        <zip>4020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lhk Feldkirch; Interne Medizin Abt.</name>
      <address>
        <city>Rankweil</city>
        <zip>6830</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Jules Bordet</name>
      <address>
        <city>Anderlecht</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires St-Luc</name>
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  <location>
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  <location>
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        <zip>80090</zip>
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  <location>
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        <zip>87042</zip>
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        <zip>13285</zip>
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        <zip>34298</zip>
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        <zip>75970</zip>
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        <zip>99437</zip>
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        <zip>45136</zip>
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        <zip>35392</zip>
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        <zip>30459</zip>
        <country>Germany</country>
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        <zip>51109</zip>
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  <location>
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      <name>Universitaetsklinikum Giessen und Marburg</name>
      <address>
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        <zip>35043</zip>
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  <location>
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        <zip>33098</zip>
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        <zip>115 22</zip>
        <country>Greece</country>
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  <location>
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      <name>Henri Dunant Hospital; Oncology Dept.</name>
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        <city>Athens</city>
        <zip>115 26</zip>
        <country>Greece</country>
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  <location>
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        <zip>115 27</zip>
        <country>Greece</country>
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        <zip>711 10</zip>
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        <zip>546 45</zip>
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      <name>AORN Ospedali dei Colli Ospedale Monaldi; UOC Pneumologia ad indirizzo Oncologico</name>
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        <city>Napoli</city>
        <state>Campania</state>
        <zip>80131</zip>
        <country>Italy</country>
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        <city>Bologna</city>
        <state>Emilia-Romagna</state>
        <zip>40138</zip>
        <country>Italy</country>
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        <state>Emilia-Romagna</state>
        <zip>43126</zip>
        <country>Italy</country>
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    <facility>
      <name>Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica</name>
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        <state>Emilia-Romagna</state>
        <zip>48100</zip>
        <country>Italy</country>
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        <city>Aviano</city>
        <state>Friuli-Venezia Giulia</state>
        <zip>33081</zip>
        <country>Italy</country>
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      <name>Policlinico Umberto I, Oncologia B</name>
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        <city>Roma</city>
        <state>Lazio</state>
        <zip>00161</zip>
        <country>Italy</country>
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      <name>Azienda Ospedaliera San Camillo Forlanini</name>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>151</zip>
        <country>Italy</country>
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  <location>
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      <name>IRCCS AOU San Martino - IST</name>
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        <city>Genova</city>
        <state>Liguria</state>
        <zip>16132</zip>
        <country>Italy</country>
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      <name>ASST Spedali Civili di Brescia</name>
      <address>
        <city>Brescia</city>
        <state>Lombardia</state>
        <zip>25123</zip>
        <country>Italy</country>
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    </facility>
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  <location>
    <facility>
      <name>Instituto Europeo di Oncologia</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20141</zip>
        <country>Italy</country>
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  <location>
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      <name>Istituto Clinico Humanitas</name>
      <address>
        <city>Rozzano (MI)</city>
        <state>Lombardia</state>
        <zip>20089</zip>
        <country>Italy</country>
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  <location>
    <facility>
      <name>Ospedale Vito Fazzi</name>
      <address>
        <city>Lecce</city>
        <state>Puglia</state>
        <zip>73100</zip>
        <country>Italy</country>
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  <location>
    <facility>
      <name>A.O.U Careggi</name>
      <address>
        <city>Florence</city>
        <state>Toscana</state>
        <zip>50124</zip>
        <country>Italy</country>
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  <location>
    <facility>
      <name>Hyogo Cancer Center</name>
      <address>
        <city>Hyogo</city>
        <zip>673-0021</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Sendai Kousei Hospital</name>
      <address>
        <city>Miyagi</city>
        <zip>980-0873</zip>
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        <zip>541-8567</zip>
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  <location>
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      <name>National Cancer Center Hospital</name>
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        <zip>104-0045</zip>
        <country>Japan</country>
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  <location>
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      <name>The Cancer Institute Hospital of JFCR</name>
      <address>
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        <zip>135-8550</zip>
        <country>Japan</country>
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  <location>
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      <name>Chungbuk National University Hospital</name>
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        <zip>28644</zip>
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        <zip>10408</zip>
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        <zip>16247</zip>
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        <zip>16499</zip>
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        <zip>51353</zip>
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      <name>Gachon University Gil Medical Center</name>
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        <zip>21565</zip>
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  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
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        <zip>463-707</zip>
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  <location>
    <facility>
      <name>Severance Hospital, Yonsei University Health System</name>
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        <zip>003-722</zip>
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      <name>Korea University Anam Hospital</name>
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        <zip>02841</zip>
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  <location>
    <facility>
      <name>Asan Medical Center</name>
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        <zip>05505</zip>
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  </location>
  <location>
    <facility>
      <name>Seoul St Mary's Hospital</name>
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        <zip>06591</zip>
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  <location>
    <facility>
      <name>Ulsan University Hosiptal</name>
      <address>
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        <zip>44033</zip>
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  </location>
  <location>
    <facility>
      <name>Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Ambulatorium Chemioterapii</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-796</zip>
        <country>Poland</country>
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  <location>
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      <name>SP ZOZ Wojewódzki Szpital Specjalistyczny nr 4; Oddzial Onkologii Klinicznej</name>
      <address>
        <city>Bytom</city>
        <zip>41-902</zip>
        <country>Poland</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter.</name>
      <address>
        <city>Gliwice</city>
        <zip>44-101</zip>
        <country>Poland</country>
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      <name>Szpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii</name>
      <address>
        <city>Koszalin</city>
        <zip>75-581</zip>
        <country>Poland</country>
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      <name>Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii</name>
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        <city>Otwock</city>
        <zip>05-400</zip>
        <country>Poland</country>
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      <name>Hospital Pulido Valente; Servico de Pneumologia</name>
      <address>
        <city>Lisboa</city>
        <zip>1796-001</zip>
        <country>Portugal</country>
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  <location>
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      <name>Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia</name>
      <address>
        <city>Porto</city>
        <zip>4099-001</zip>
        <country>Portugal</country>
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  <location>
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      <name>Hospital CUF Porto; Servico Pneumologia</name>
      <address>
        <city>Porto</city>
        <zip>4100-180</zip>
        <country>Portugal</country>
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  <location>
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      <name>IPO do Porto; Servico de Oncologia Medica</name>
      <address>
        <city>Porto</city>
        <zip>4200-072</zip>
        <country>Portugal</country>
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    <facility>
      <name>CHVNG/E_Unidade 1; Servico de Pneumologia</name>
      <address>
        <city>Vila Nova de Gaia</city>
        <zip>4434-502</zip>
        <country>Portugal</country>
      </address>
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  <location>
    <facility>
      <name>Regional Clinical Oncology Hospital</name>
      <address>
        <city>Yaroslavl</city>
        <state>Jaroslavl</state>
        <zip>150054</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy</name>
      <address>
        <city>Moscow</city>
        <state>Moskovskaja Oblast</state>
        <zip>143422</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)</name>
      <address>
        <city>Saint-Petersburg</city>
        <state>Sankt Petersburg</state>
        <zip>197758</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GBUZ Leningradskaya state clinical hospital</name>
      <address>
        <city>St. Petersburg</city>
        <state>Sankt Petersburg</state>
        <zip>194291</zip>
        <country>Russian Federation</country>
      </address>
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  <location>
    <facility>
      <name>Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia</name>
      <address>
        <city>A Coruña</city>
        <state>LA Coruña</state>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vall d?Hebron Institute of Oncology (VHIO), Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Catala d Oncologia Hospital Duran i Reynals</name>
      <address>
        <city>Barcelona</city>
        <zip>08908</zip>
        <country>Spain</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz; Servicio de Oncologia</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia</name>
      <address>
        <city>Sevilla</city>
        <zip>41014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia</name>
      <address>
        <city>Valencia</city>
        <zip>46015</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari i Politecnic La Fe; Oncologia</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Addenbrookes Hospital</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Beatson West of Scotland Cancer Centre</name>
      <address>
        <city>Glasgow</city>
        <zip>G12 0YN</zip>
        <country>United Kingdom</country>
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  </location>
  <location>
    <facility>
      <name>Huddersfield Royal Infirmary; The Learning Centre</name>
      <address>
        <city>Huddersfield</city>
        <zip>HD3 3EA</zip>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Barts &amp; London School of Med; Medical Oncology</name>
      <address>
        <city>London</city>
        <zip>EC1A 7BE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College London Hospital</name>
      <address>
        <city>London</city>
        <zip>N7 9NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Free Hospital</name>
      <address>
        <city>London</city>
        <zip>NW3 2QS</zip>
        <country>United Kingdom</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Chelsea &amp; Westminster Hospital</name>
      <address>
        <city>London</city>
        <zip>SW10 9TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://forpatients.roche.com/en/trials/cancer/lung-cancer/study-of-atezolizumab-in-combination-with-cabozantinib--77103.html</url>
    <description>Related Info</description>
  </link>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>May 29, 2023</last_update_submitted>
  <last_update_submitted_qc>May 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 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>Docetaxel</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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04471428
org study id: GO41892
nct id: NCT04471428
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase III, multicenter, randomized, open-label study designed to evaluate the
      efficacy, safety, and pharmacokinetics of atezolizumab given in combination with cabozantinib
      compared with docetaxel monotherapy in patients with metastatic NSCLC, with no sensitizing
      EGFR mutation or ALK translocation, who have progressed following treatment with
      platinum-containing chemotherapy and anti-PD-L1/PD-1 antibody, administered concurrently or
      sequentially.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Survival (OS)
time frame: Up to approximately 43 months
description: Overall survival (OS) after randomization, defined as the time from randomization to death from any cause.
measure: PFS, as Determined by Investigator
time frame: Up to approximately 43 months
description: PFS after randomization, defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator according to RECIST v1.1, or death from any cause (whichever occurs first).
measure: Confirmed Objective Response Rate (ORR), as Determined by Investigator
time frame: Up to approximately 43 months
description: Confirmed objective response rate (ORR), defined as the proportion of participants with a complete or partial response on two consecutive occasions >=4 weeks apart, as determined by the investigator according to RECIST v1.1.
measure: Duration of response (DOR), as Determined by Investigator
time frame: Up to approximately 43 months
description: Duration of response (DOR) for participants with confirmed ORR, defined as the time from the first occurrence of a documented objective response to disease progression, as determined by the investigator according to RECIST v1.1, or death from any cause (whichever occurs first).
measure: Time to Confirmed Deterioration in Patient-Reported Physical Functioning (PF)
time frame: Up to approximately 43 months
description: Time to confirmed deterioration in patient-reported physical functioning (PF) as measured by the corresponding scores from the European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life-Core 30 (QLQ-C30).
measure: Time to Confirmed Deterioration in Patient-Reported Global Health Status (GHS)
time frame: Up to approximately 43 months
description: Time to confirmed deterioration in patient-reported Global Health Status (GHS) as measured by the corresponding scores from the European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life-Core 30 (QLQ-C30).
measure: PFS Rates Assessed by Investigator
time frame: 6 months and 1 year
measure: OS Rates
time frame: 1 and 2 years
measure: Percentage of Participants With Adverse Events
time frame: Up to approximately 43 months
measure: Minimum Serum Concentration (Cmin) of Atezolizumab
time frame: Predose and postdose on Day 1 of Cycle 1; and Predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (each cycle is 21 days)
measure: Maximum Serum Concentration (Cmax) of Atezolizumab
time frame: Predose and postdose on Day 1 of Cycle 1; and Predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (each cycle is 21 days)
measure: Minimum Serum Concentration (Cmin) of Cabozantinib
time frame: Predose on Day 1 of Cycles 1, 2, 3, 4, and 5 (each cycle is 21 days)
measure: Maximum Serum Concentration (Cmax) of Cabozantinib
time frame: Predose on Day 1 of Cycles 1, 2, 3, 4, and 5 (each cycle is 21 days)
measure: Percentage of Participants with Anti-Drug Antibodies (ADAs) to Atezolizumab
time frame: Predose on Day 1 of Cycle 1 (each cycle is 21 days)
measure: Number of ADAs to Atezolizumab After Treatment
time frame: Predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 (each cycle is 21 days)
arm group label: Atezolizumab + Cabozantinib
arm group type: Experimental
description: Participants will receive atezolizumab on Day 1 of each 21-day cycle and cabozantinib orally once daily on days 1-21 of each cycle.
arm group label: Docetaxel
arm group type: Active Comparator
description: Participants will receive docetaxel on Day 1 of each 21-day cycle.
intervention type: Drug
intervention name: Cabozantinib
description: Cabozantinib will be administered orally, once daily at a dose of 40 mg on Days 1-21 of each cycle.
arm group label: Atezolizumab + Cabozantinib
intervention type: Drug
intervention name: Atezolizumab
description: Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.
arm group label: Atezolizumab + Cabozantinib
other name: Tecentriq
intervention type: Drug
intervention name: Docetaxel
description: Docetaxel will be administered by IV infusion at a starting dose of 75mg/m2 on Day 1 of each 21-day cycle.
arm group label: Docetaxel
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
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country: Australia
country: Austria
country: Belgium
country: France
country: Germany
country: Greece
country: Italy
country: Japan
country: Korea, Republic of
country: Poland
country: Portugal
country: Russian Federation
country: Spain
country: United Kingdom
country: United States
url: https://forpatients.roche.com/en/trials/cancer/lung-cancer/study-of-atezolizumab-in-combination-with-cabozantinib--77103.html
description: Related Info
responsible party type: Sponsor
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Docetaxel
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).