<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/NCT03285763</url>
  </required_header>
  <id_info>
    <org_study_id>MO39171</org_study_id>
    <secondary_id>2017-001409-34</secondary_id>
    <nct_id>NCT03285763</nct_id>
  </id_info>
  <brief_title>A Study of Atezolizumab (Tecentriq) to Investigate Long-term Safety and Efficacy in Previously-treated Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)</brief_title>
  <acronym>TAIL</acronym>
  <official_title>A Phase III/IV, Single Arm, Multicenter Study of Atezolizumab (Tecentriq) to Investigate Long-term Safety and Efficacy in Previously-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (TAIL)</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>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase III/IV, single-arm, multicenter study of the long-term safety and efficacy of&#xD;
      atezolizumab treatment in participants with Stage IIIb or Stage IV NSCLC who have progressed&#xD;
      after standard systemic chemotherapy (including if given in combination with anti-programmed&#xD;
      cell death protein 1 [anti-PD-1] therapy, after anti-PD-1 as monotherapy, or after tyrosine&#xD;
      kinase inhibitor [TKI] therapy). The study will consist of a Screening Period, a Treatment&#xD;
      Period, a Treatment Discontinuation Visit, and a Follow-Up Period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 25, 2017</start_date>
  <completion_date type="Actual">April 7, 2022</completion_date>
  <primary_completion_date type="Actual">April 7, 2022</primary_completion_date>
  <phase>Phase 4</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>Percentage of Participants with Adverse Events</measure>
    <time_frame>Baseline up to 4 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Alive 2 Years After Initiation of Treatment</measure>
    <time_frame>Baseline up to Year 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Baseline up to death (up to 4 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival Based on Disease Status as Evaluated By the Investigator in Accordance With Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (v.1.1)</measure>
    <time_frame>Baseline up to disease progression or death whichever occurs first (up to 4 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire</measure>
    <time_frame>Day 1 of first 3 cycles (21-day cycle), then every 6 weeks for 48 weeks; thereafter every 9 weeks until disease progression or until treatment discontinuation (up to 4 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Supplemental Lung Cancer Module (EORTC QLQ-LC13)</measure>
    <time_frame>Day 1 of first 3 cycles (21-day cycle), then every 6 weeks for 48 weeks; thereafter every 9 weeks until disease progression or until treatment discontinuation (up to 4 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival Based on Disease Status as Evaluated By the Investigator in Accordance With Modified RECIST</measure>
    <time_frame>Baseline up to disease progression or death whichever occurs first (up to 4 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Alive 3 Years After Initiation of Treatment</measure>
    <time_frame>Baseline up to Year 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Objective Reponse as Assessed by the Investigator According to RECIST v1.1</measure>
    <time_frame>Baseline up to disease progression or death whichever occurs first (up to 4 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Objective Reponse as Assessed by the Investigator According to Modified RECIST</measure>
    <time_frame>Baseline up to disease progression or death whichever occurs first (up to 4 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response as Assessed by the Investigator According to RECIST v.1.1</measure>
    <time_frame>From date of first objective response up to disease progression or death whichever occurs first (up to 4 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response as Assessed by the Investigator According to Modified RECIST</measure>
    <time_frame>From date of first objective response up to disease progression or death whichever occurs first (up to 4 years)</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">619</enrollment>
  <condition>Carcinoma, Non-Small-Cell Lung</condition>
  <arm_group>
    <arm_group_label>Atezolizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with Stage IIIb or State IV NSCLC who have progressed after standard systemic chemotherapy will receive atezolizumab until Investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atezolizumab</intervention_name>
    <description>Participants will receive 1200 milligrams (mg) of atezolizumab administered by intravenous infusion on Day 1 of every 3-week cycle until Investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first).</description>
    <arm_group_label>Atezolizumab</arm_group_label>
    <other_name>RO5541267</other_name>
    <other_name>Tecentriq</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically documented Stage IIIb or Stage IV NSCLC that has&#xD;
             progressed following standard systemic chemotherapy (including if given in combination&#xD;
             with anti-PD-1 therapy, after anti-PD-1 as monotherapy, or after TKI therapy).&#xD;
             Participants with a previously detected sensitizing epidermal growth factor receptor&#xD;
             (EGFR) mutation or echinoderm microtubule-associated protein-like 4-anaplastic&#xD;
             lymphoma kinase (ALK) fusion oncogene must have received targeted therapy (TKI)&#xD;
             followed by at least one line of standard systemic chemotherapy prior to receiving&#xD;
             atezolizumab. Overall, participants should not have received more than two lines of&#xD;
             standard systemic chemotherapy. Participants who have discontinued first-line or&#xD;
             second-line therapy due to intolerance are also eligible&#xD;
&#xD;
          -  The last dose of prior systemic anticancer therapy or targeted therapy must have been&#xD;
             administered more than or equal to (≥) 21 days prior to randomization.&#xD;
&#xD;
          -  The last dose of prior anti-PD-1 therapy must have been administered. Nivolumab must&#xD;
             have been discontinued &gt;= 14 days and pembrolizumab &gt;= 21 days prior to study&#xD;
             treatment initiation, providing that these treatments were not administered in a&#xD;
             clinical trial setting.&#xD;
&#xD;
          -  Measurable disease, as defined by Response Evaluation Criteria for Solid Tumors,&#xD;
             Version 1.1 (RECIST v1.1)&#xD;
&#xD;
          -  Participants with asymptomatic central nervous system (CNS) metastases (treated or&#xD;
             untreated), as determined by computed tomography (CT) or magnetic resonance imaging&#xD;
             evaluation during screening and prior radiographic evaluation, are eligible&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2&#xD;
&#xD;
          -  Life expectancy ≥ 12 weeks&#xD;
&#xD;
          -  Adequate hematologic and end-organ function&#xD;
&#xD;
          -  For women of childbearing potential: agreement to remain abstinent (refrain from&#xD;
             heterosexual intercourse) or use contraceptive methods that result in a failure rate&#xD;
             of less than (&lt;) 1 percent (%) per year during the treatment period and for at least 5&#xD;
             months after the last dose of atezolizumab&#xD;
&#xD;
          -  Participants must have recovered (i.e., improvement to Grade 1 or better) from all&#xD;
             acute toxicities from previous therapy, excluding alopecia and toxicities related to&#xD;
             prior anti-PD-1-therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Symptomatic CNS metastases&#xD;
&#xD;
          -  Spinal cord compression not definitively treated with surgery and/or radiation or&#xD;
             previously diagnosed and treated spinal cord compression without evidence that disease&#xD;
             has been clinically stable for ≥ 2 weeks prior to study treatment initiation&#xD;
&#xD;
          -  Leptomeningeal disease&#xD;
&#xD;
          -  Uncontrolled pericardial effusion or ascites requiring recurrent drainage procedures&#xD;
&#xD;
          -  Pregnant or lactating, or intending to become pregnant during the study&#xD;
&#xD;
          -  Evidence of significant uncontrolled concomitant disease that could affect compliance&#xD;
             with the protocol, including significant liver disease (such as cirrhosis,&#xD;
             uncontrolled major seizure disorder, or superior vena cava syndrome)&#xD;
&#xD;
          -  Significant cardiovascular disease, such as New York Heart Association cardiac disease&#xD;
             ≥ Class III, myocardial infarction within 3 months, unstable arrhythmias, or unstable&#xD;
             angina&#xD;
&#xD;
          -  Significant renal disorder requiring dialysis or indication for renal transplant&#xD;
&#xD;
          -  Treatment with any other investigational agent or participation in another clinical&#xD;
             trial with therapeutic intent within 28 days prior to study treatment initiation&#xD;
&#xD;
          -  Major surgical procedure within 4 weeks prior to study treatment initiation or&#xD;
             anticipation of need for a major surgical procedure during the course of the study&#xD;
             other than for diagnosis&#xD;
&#xD;
          -  Inability to understand the local language(s) for which the EORTC QLQ-LC13 and&#xD;
             EQ-5D-5L questionnaires are available&#xD;
&#xD;
          -  History of severe allergic, anaphylactic, or other hypersensitivity reactions to&#xD;
             chimeric or humanized antibodies or fusion proteins&#xD;
&#xD;
          -  Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster&#xD;
             ovary cells or any component of the atezolizumab formulation&#xD;
&#xD;
          -  History of autoimmune disease are allowed if controlled and on stable treatment (i.e.,&#xD;
             same treatment, same dose) for the last 12 weeks&#xD;
&#xD;
          -  Prior allogeneic stem cell or solid organ transplantation&#xD;
&#xD;
          -  History of idiopathic pulmonary fibrosis, including pneumonitis, drug-induced&#xD;
             pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic&#xD;
             organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan&#xD;
&#xD;
          -  Active tuberculosis&#xD;
&#xD;
          -  Administration of a live, attenuated vaccine within 4 weeks prior to study treatment&#xD;
             initiation&#xD;
&#xD;
          -  Prior treatment with cluster of differentiation 137 (CD137) agonists or immune&#xD;
             checkpoint blockade therapies other than anti-PD-1 therapy, including anti-programmed&#xD;
             death-ligand 1 therapeutic antibodies&#xD;
&#xD;
          -  Treatment with systemic immunostimulatory agents (including, but not limited to,&#xD;
             interferons or interleukin-2) within 4 weeks or five half-lives of the drug, whichever&#xD;
             is longer, prior to initiation of study treatment&#xD;
&#xD;
          -  Specifically for participants without autoimmune disease: treatment with systemic&#xD;
             corticosteroids or other systemic immunosuppressive medications (including but not&#xD;
             limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate,&#xD;
             thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to study&#xD;
             treatment initiation, or anticipated requirement for systemic immunosuppressive&#xD;
             medications during the trial. For participants with CNS metastases, use of prednisone&#xD;
             at a stable dose (or dose equivalent) of &lt;= 20 mg/day is acceptable.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Aleman</name>
      <address>
        <city>Caba</city>
        <zip>C1118AAT</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Oncologico Riojano Integral (CORI)</name>
      <address>
        <city>La Rioja</city>
        <zip>F5300COE</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CETUS Hospital Dia Oncologia</name>
      <address>
        <city>Uberaba</city>
        <state>MG</state>
        <zip>38082-049</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital das Clinicas - UFRGS</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90035-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Pesquisas Oncologicas - CEPON</name>
      <address>
        <city>Florianopolis</city>
        <state>SC</state>
        <zip>88034-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Alemao Oswaldo Cruz</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>01323-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Hospital</name>
      <address>
        <city>Beijing City</city>
        <zip>100006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100853</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>First Affiliated Hospital of Soochow University</name>
      <address>
        <city>Suzhou</city>
        <zip>215006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henan Cancer Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <zip>450008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Organizacion Sanitas Internacional</name>
      <address>
        <city>Bogota, D.C.</city>
        <zip>111321</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica CIMCA</name>
      <address>
        <city>San José</city>
        <zip>10103</zip>
        <country>Costa Rica</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sjællands Universitetshospital, Næstved; Onkologisk Afdeling</name>
      <address>
        <city>Naestved</city>
        <zip>4700</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odense Universitetshospital, Onkologisk Afdeling R</name>
      <address>
        <city>Odense C</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vejle Sygehus; Onkologisk Afdeling</name>
      <address>
        <city>Vejle</city>
        <zip>7100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine</name>
      <address>
        <city>Athens</city>
        <zip>115 22</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uoa Sotiria Hospital; Oncology</name>
      <address>
        <city>Athens</city>
        <zip>115 27</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Agioi Anargyroi; 3Rd Dept. of Medical Oncology</name>
      <address>
        <city>Athens</city>
        <zip>145 64</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ General Hosp Heraklion; Medical Oncology</name>
      <address>
        <city>Heraklion</city>
        <zip>711 10</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Patras Medical Oncology</name>
      <address>
        <city>Patras</city>
        <zip>265 04</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diavalkaniko Hospital</name>
      <address>
        <city>Thessaloniki</city>
        <zip>570 01</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncomedica</name>
      <address>
        <city>Guatemala</city>
        <zip>01010</zip>
        <country>Guatemala</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ist. Ricovero e Cura a Carattere Scientifico-Centro Rif. Oncologico della Basilica</name>
      <address>
        <city>Rionero In Vulture (PZ)</city>
        <state>Basilicata</state>
        <zip>85028</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Campus Universitario S.Venuta; Centro Oncologico T.Campanella</name>
      <address>
        <city>Catanzaro</city>
        <state>Calabria</state>
        <zip>88100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica</name>
      <address>
        <city>Bologna</city>
        <state>Emilia-Romagna</state>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcispedale Santa Maria Nuova; Medicina Nucleare</name>
      <address>
        <city>Reggio Emilia</city>
        <state>Emilia-Romagna</state>
        <zip>42100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche</name>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>00161</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ. Ospedaliera San Giovanni - Addolorata</name>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>00184</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniche Gavazzeni S.p.A.; Dip. di Oncologia Pneumologica ed Urologica</name>
      <address>
        <city>Bergamo</city>
        <state>Lombardia</state>
        <zip>24125</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica</name>
      <address>
        <city>Brescia</city>
        <state>Lombardia</state>
        <zip>25123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedali Riuniti Di Ancona; Oncology</name>
      <address>
        <city>Ancona</city>
        <state>Marche</state>
        <zip>60121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Oncologico A.Businco; Div. Oncologia Medica II</name>
      <address>
        <city>Cagliari</city>
        <state>Sardegna</state>
        <zip>09121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Cannizzaro, Oncologia</name>
      <address>
        <city>Catania</city>
        <state>Sicilia</state>
        <zip>95126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia</name>
      <address>
        <city>Firenze</city>
        <state>Toscana</state>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare</name>
      <address>
        <city>Pisa</city>
        <state>Toscana</state>
        <zip>56124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Regionale Umberto Parini; S.C. Oncologia</name>
      <address>
        <city>Aosta</city>
        <state>Valle D'Aosta</state>
        <zip>11100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ULSS2 Marca Trevigiana; UOC Oncologia Medica - Distretto di Treviso</name>
      <address>
        <city>Treviso</city>
        <state>Veneto</state>
        <zip>31100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riga East Clinical University Hospital Latvian Oncology Centre</name>
      <address>
        <city>Riga</city>
        <zip>LV-1079</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pauls Stradins Clinical University Hospital</name>
      <address>
        <city>Rīga</city>
        <zip>LV-1002</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hotel Dieu de France; Oncology</name>
      <address>
        <city>Beirut</city>
        <zip>2063 1111</zip>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bellevue Medical Center</name>
      <address>
        <city>El-Metn</city>
        <zip>2241</zip>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute Kanser Negara (IKN)</name>
      <address>
        <city>Putrajaya</city>
        <state>FED. Territory OF Kuala Lumpur</state>
        <zip>62250</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Pulau Pinang; Jabatan Respiratori</name>
      <address>
        <city>Georgetown</city>
        <state>Penang</state>
        <zip>10450</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Malaya Medical Centre; Clinical Oncology Unit,</name>
      <address>
        <city>Kuala Lumpur</city>
        <zip>59100</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Umum Sarawak; Oncology and Radiotherapy</name>
      <address>
        <city>Kuching</city>
        <zip>93586</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Miriam Cancer Hospital</name>
      <address>
        <city>Tanjung Bungah</city>
        <zip>11200</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Pharma Professional Research</name>
      <address>
        <city>Cdmx</city>
        <state>Mexico CITY (federal District)</state>
        <zip>03100</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncologico Potosino</name>
      <address>
        <city>San Luis Potosí</city>
        <state>SAN LUIS Potosi</state>
        <zip>78209</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigacion Clinica Merida</name>
      <address>
        <city>Mérida</city>
        <state>Yucatan</state>
        <zip>97125</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Oncologico Internacional</name>
      <address>
        <city>Mexico D.F.</city>
        <zip>04700</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oaxaca Site Management Organization</name>
      <address>
        <city>Oaxaca</city>
        <zip>68000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique le Littoral</name>
      <address>
        <city>Casablanca</city>
        <zip>20100</zip>
        <country>Morocco</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Hassan II</name>
      <address>
        <city>FES</city>
        <zip>30000</zip>
        <country>Morocco</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut National D'oncologie Sidi Med Benabdellah</name>
      <address>
        <city>Rabat</city>
        <zip>6213</zip>
        <country>Morocco</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meander Medisch Centrum</name>
      <address>
        <city>Amersfoort</city>
        <zip>3813 TZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ziekenhuis Rijnstate</name>
      <address>
        <city>Arnhem</city>
        <zip>6815 AD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amphia Ziekenhuis; Afdeling Longziekten</name>
      <address>
        <city>Breda</city>
        <zip>4818 CK</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tergooiziekenhuizen, loc. Hilversum</name>
      <address>
        <city>Hilversum</city>
        <zip>1213 HX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMC Radboud Nijmegen</name>
      <address>
        <city>Nijmegen</city>
        <zip>6500 HB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Isala</name>
      <address>
        <city>Zwolle</city>
        <zip>8025 AB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hemato Oncologico Panama</name>
      <address>
        <city>Panama</city>
        <zip>0832</zip>
        <country>Panama</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Regional de Enfermedades Neoplásicas del Sur; Centro de Inv. de Medicina Oncológica</name>
      <address>
        <city>Arequipa</city>
        <zip>5154</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional</name>
      <address>
        <city>Lima</city>
        <zip>Lima 41</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Perpetual Help System DALTA Medical Center</name>
      <address>
        <city>Las Pinas</city>
        <zip>1740</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Medical City Hospital; Cancer Research Room</name>
      <address>
        <city>Pasig</city>
        <zip>1605</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Avenue Medical Center</name>
      <address>
        <city>Quezon City</city>
        <zip>1100</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Narodowy Instytut Onkologii Oddzial Gliwice; II Klinika Radioterapii i Chemioterapii</name>
      <address>
        <city>Gliwice</city>
        <zip>44-101</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie</name>
      <address>
        <city>Olsztyn</city>
        <zip>10-357</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii</name>
      <address>
        <city>Otwock</city>
        <zip>05-400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Kliniczny; Przemienienia Panskiego;Uniwersytetu Medyczny im.; Karola Marcinkowskiego w Pozna</name>
      <address>
        <city>Poznan</city>
        <zip>60-569</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers</name>
      <address>
        <city>Warszawa</city>
        <zip>02-781</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Clinic Golnik</name>
      <address>
        <city>Golnik</city>
        <zip>4204</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Univ. Central de Asturias; Servicio de Oncologia</name>
      <address>
        <city>Oviedo</city>
        <state>Asturias</state>
        <zip>33011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Marques de Valdecilla; Servicio de Oncologia</name>
      <address>
        <city>Santander</city>
        <state>Cantabria</state>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Provincial de Castellon; Servicio de Oncologia</name>
      <address>
        <city>Castellon de La Plana</city>
        <state>Castellon</state>
        <zip>12002</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Reina Sofia; Servicio de Oncologia</name>
      <address>
        <city>Córdoba</city>
        <state>Cordoba</state>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Donostia; Servicio de Oncologia Medica</name>
      <address>
        <city>San Sebastian</city>
        <state>Guipuzcoa</state>
        <zip>20080</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Son Espases; Servicio de Oncologia</name>
      <address>
        <city>Palma De Mallorca</city>
        <state>Islas Baleares</state>
        <zip>07014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario Insular-Materno Infantil; Servicio de Oncologia</name>
      <address>
        <city>Las Palmas de Gran Canaria</city>
        <state>LAS Palmas</state>
        <zip>35016</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Puerta de Hierro; Servicio de Oncologia</name>
      <address>
        <city>Majadahonda</city>
        <state>Madrid</state>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Quiron de Madrid; Servicio de Oncologia</name>
      <address>
        <city>Pozuelo de Alarcon</city>
        <state>Madrid</state>
        <zip>28223</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Infanta Sofia; Servico de Oncologia</name>
      <address>
        <city>San Sebastian de Los Reyes</city>
        <state>Madrid</state>
        <zip>28702</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Navarra; Servicio de Oncologia</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Canarias;servicio de Oncologia</name>
      <address>
        <city>La Laguna</city>
        <state>Tenerife</state>
        <zip>38320</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Univ. de Alicante; Servicio de Oncologia</name>
      <address>
        <city>Alicante</city>
        <zip>3010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital del Mar; Servicio de Oncologia</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínic i Provincial; Servicio de Hematología y Oncología</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia</name>
      <address>
        <city>Barcelona</city>
        <zip>08041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari de Girona Dr Josep Trueta; Departamento de Oncologia Medica</name>
      <address>
        <city>Girona</city>
        <zip>17007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de las Nieves; Servicio de Oncologia</name>
      <address>
        <city>Granada</city>
        <zip>18014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia</name>
      <address>
        <city>Jaen</city>
        <zip>23007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Lucus Augusti; Servicio de Oncologia</name>
      <address>
        <city>Lugo</city>
        <zip>27003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Ramon y Cajal; Servicio de Oncologia</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre; Servicio de Oncologia</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </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 Universitario Virgen del Rocio; Servicio de Oncologia</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Valencia; Servicio de oncologia</name>
      <address>
        <city>Valencia</city>
        <zip>46014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario la Fe; Servicio de Oncologia</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sahlgrenska Universitetssjukhuset, Lungmedicinkliniken</name>
      <address>
        <city>Goeteborg</city>
        <zip>41345</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska Universitetssjukhuset, Solna; Kliniska prövningsenheten Z:4:01</name>
      <address>
        <city>Stockholm</city>
        <zip>171 76</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uppsala University Hospital; Department of Oncology</name>
      <address>
        <city>Uppsala</city>
        <zip>751 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tawam Hospital</name>
      <address>
        <city>Al Ain</city>
        <zip>15258</zip>
        <country>United Arab Emirates</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal United Hospital</name>
      <address>
        <city>Bath</city>
        <zip>BA1 3NG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Birmingham Heartlands Hospital ; Department of Respiratory Medicine (Rm 30)</name>
      <address>
        <city>Birmingham</city>
        <zip>B9 5SS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Castle Hill Hospital; The Queen's Centre for Oncology &amp; Haematology</name>
      <address>
        <city>Hull</city>
        <zip>HU16 5JQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Forth Valley Royal Hospital ; Oncology Department</name>
      <address>
        <city>Larbert</city>
        <zip>FK5 4QE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chelsea &amp; Westminster Hospital</name>
      <address>
        <city>London</city>
        <zip>SW10 9NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Vernon Cancer Centre</name>
      <address>
        <city>Northwood</city>
        <zip>HA6 2RN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Cross Hospital</name>
      <address>
        <city>Wolverhampton</city>
        <zip>WV10 0QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Brazil</country>
    <country>China</country>
    <country>Colombia</country>
    <country>Costa Rica</country>
    <country>Denmark</country>
    <country>Greece</country>
    <country>Guatemala</country>
    <country>Italy</country>
    <country>Latvia</country>
    <country>Lebanon</country>
    <country>Malaysia</country>
    <country>Mexico</country>
    <country>Morocco</country>
    <country>Netherlands</country>
    <country>Panama</country>
    <country>Peru</country>
    <country>Philippines</country>
    <country>Poland</country>
    <country>Slovenia</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United Arab Emirates</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Algeria</country>
    <country>Egypt</country>
  </removed_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>May 25, 2022</last_update_submitted>
  <last_update_submitted_qc>May 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2022</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>Atezolizumab</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>March 15, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03285763
org study id: MO39171
secondary id: 2017-001409-34
nct id: NCT03285763
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a Phase III/IV, single-arm, multicenter study of the long-term safety and efficacy of
      atezolizumab treatment in participants with Stage IIIb or Stage IV NSCLC who have progressed
      after standard systemic chemotherapy (including if given in combination with anti-programmed
      cell death protein 1 [anti-PD-1] therapy, after anti-PD-1 as monotherapy, or after tyrosine
      kinase inhibitor [TKI] therapy). The study will consist of a Screening Period, a Treatment
      Period, a Treatment Discontinuation Visit, and a Follow-Up Period.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants with Adverse Events
time frame: Baseline up to 4 years
measure: Percentage of Participants Alive 2 Years After Initiation of Treatment
time frame: Baseline up to Year 2
measure: Overall Survival (OS)
time frame: Baseline up to death (up to 4 years)
measure: Progression-Free Survival Based on Disease Status as Evaluated By the Investigator in Accordance With Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (v.1.1)
time frame: Baseline up to disease progression or death whichever occurs first (up to 4 years)
measure: EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire
time frame: Day 1 of first 3 cycles (21-day cycle), then every 6 weeks for 48 weeks; thereafter every 9 weeks until disease progression or until treatment discontinuation (up to 4 years)
measure: European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Supplemental Lung Cancer Module (EORTC QLQ-LC13)
time frame: Day 1 of first 3 cycles (21-day cycle), then every 6 weeks for 48 weeks; thereafter every 9 weeks until disease progression or until treatment discontinuation (up to 4 years)
measure: Progression-Free Survival Based on Disease Status as Evaluated By the Investigator in Accordance With Modified RECIST
time frame: Baseline up to disease progression or death whichever occurs first (up to 4 years)
measure: Percentage of Participants Alive 3 Years After Initiation of Treatment
time frame: Baseline up to Year 3
measure: Percentage of Participants with Objective Reponse as Assessed by the Investigator According to RECIST v1.1
time frame: Baseline up to disease progression or death whichever occurs first (up to 4 years)
measure: Percentage of Participants with Objective Reponse as Assessed by the Investigator According to Modified RECIST
time frame: Baseline up to disease progression or death whichever occurs first (up to 4 years)
measure: Duration of Response as Assessed by the Investigator According to RECIST v.1.1
time frame: From date of first objective response up to disease progression or death whichever occurs first (up to 4 years)
measure: Duration of Response as Assessed by the Investigator According to Modified RECIST
time frame: From date of first objective response up to disease progression or death whichever occurs first (up to 4 years)
arm group label: Atezolizumab
arm group type: Experimental
description: Participants with Stage IIIb or State IV NSCLC who have progressed after standard systemic chemotherapy will receive atezolizumab until Investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first).
intervention type: Drug
intervention name: Atezolizumab
description: Participants will receive 1200 milligrams (mg) of atezolizumab administered by intravenous infusion on Day 1 of every 3-week cycle until Investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first).
arm group label: Atezolizumab
other name: RO5541267
other name: Tecentriq
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: Argentina
country: Brazil
country: China
country: Colombia
country: Costa Rica
country: Denmark
country: Greece
country: Guatemala
country: Italy
country: Latvia
country: Lebanon
country: Malaysia
country: Mexico
country: Morocco
country: Netherlands
country: Panama
country: Peru
country: Philippines
country: Poland
country: Slovenia
country: Spain
country: Sweden
country: United Arab Emirates
country: United Kingdom
country: Algeria
country: Egypt
responsible party type: Sponsor
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Atezolizumab
submitted: March 15, 2023