<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/NCT04501497</url>
  </required_header>
  <id_info>
    <org_study_id>J-TAIL-2</org_study_id>
    <nct_id>NCT04501497</nct_id>
  </id_info>
  <brief_title>Prospective Multicenter Observational Study of Atezolizumab Combination Therapy in Lung Cancer (J-TAIL-2)</brief_title>
  <official_title>Prospective Multicenter Observational Study of Atezolizumab Combination Therapy in Patients With Unresectable, Advanced and Recurrent Non-small Cell Lung Cancer or Extensive Disease Small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chugai Pharmaceutical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Japan Lung Cancer Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chugai Pharmaceutical</source>
  <oversight_info>
    <has_dmc>No</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 multi-center observational study of atezolizumab combination therapy in patients&#xD;
      with unresectable, advanced and recurrent non-small cell lung cancer(NSCLC) or extensive&#xD;
      disease small cell lung cancer(ED-SCLC). 800 patients in NSCLC cohort and 400 patients in&#xD;
      ED-SCLC cohort will be enrolled in this trial to assess the efficacy and safety of this&#xD;
      combination.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary endpoint: 12 months OS, Secondary endpoints: Overall Survival(OS), 6 months survival&#xD;
      rate(6mo OS), 12 months survival rate(12mo OS), Progression-Free Survival(PFS), Time to&#xD;
      treatment failure (TTF), Objective Response Rate(ORR), Disease Control Rate(DCR), Duration of&#xD;
      Response(DOR) ,Safety and Comprehensive geriatric assessment(G8)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 21, 2020</start_date>
  <completion_date type="Anticipated">August 16, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 16, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>12 months survival rate</measure>
    <time_frame>Baseline up to 12 Months</time_frame>
    <description>Percentage of participants alive 12 months after initiation of treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>Up to death (up to 3 years)</time_frame>
    <description>OS was defined as the time from the first day of study treatment to death due to any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6 moths survival rate</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Percentage of participants alive 6 months after initiation of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>18 moths survival rate</measure>
    <time_frame>Up to 18 months</time_frame>
    <description>Percentage of participants alive 18 months after initiation of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival(PFS)</measure>
    <time_frame>Up to disease progression or death whichever occurs first (up to 3 years)</time_frame>
    <description>PFS based on disease status as evaluated by the investigator in accordance with Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (v1.1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to treatment failure (TTF)</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>TTF was defined as the time from the first day of study treatment to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-treatment transfer rate</measure>
    <time_frame>Up to post-treatment is started (up to 3 years)</time_frame>
    <description>Rate of patients who received drug therapy for primary disease after study treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate(ORR)</measure>
    <time_frame>Up to disease progression or death whichever occurs first (up to 3 years)</time_frame>
    <description>Percentage of participants with objective response as assessed by the investigator according to RECIST v1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response(DOR)</measure>
    <time_frame>From date of first objective response up to disease progression or death whichever occurs first (up to 3 years)</time_frame>
    <description>Duration of Response as Assessed by the Investigator According to RECIST v1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate(DCR)</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Percentage of patients with controled disease as Assessed by the investigator according to RECIST v1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with adverse events(Adverse Reactions)</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>The incidence of worst-grade adverse events on study as graded by NCI-CTCAE v5.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comprehensive geriatric assessment (G8)</measure>
    <time_frame>At baseline</time_frame>
    <description>The G-8 screening tool was developed to identify elderly cancer patients who would benefit from comprehensive geriatric assessment</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1200</enrollment>
  <condition>Non-small Cell Lung Cancer</condition>
  <condition>Extensive Disease Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>NSCLC cohort (N=800)</arm_group_label>
    <description>Patients with locally advanced or metastatic non-small cell lung cancer who are planning to provide Atezolizumab combination thearapy as the most ppropriate medical care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ED-SCLC cohort (N=400)</arm_group_label>
    <description>Patients with extensive disease small cell lung cancer who are planning to provide Atezolizumab combination thearapy as the most ppropriate medical care</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are planning to provide Atezolizumab combination therapy as the most&#xD;
        appropriate medical care for patients and who meet the Eligibility criteria at&#xD;
        registration.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        &lt; non-small cell lung cancer cohort&gt;&#xD;
&#xD;
          1. Patients 20 years of age or older at the time of signed consent.&#xD;
&#xD;
          2. Patients with unresectable, advanced and recurrent non-small cell lung cancer.&#xD;
&#xD;
          3. Patients who are scheduled to start atezolizumab combination therapy in clinical&#xD;
             practice, based on the atezolizumab package insert and the Optimal Use Promotion&#xD;
             Guideline.&#xD;
&#xD;
          4. Patients who signed informed consent form before enrolling the study. The consent from&#xD;
             a legally acceptable representative is required for the patients with uncertain&#xD;
             capacity of judgments.&#xD;
&#xD;
        &lt;extensive disease small cell lung cancer cohort&gt;&#xD;
&#xD;
          1. Patients 20 years of age or older at the time of signed consent.&#xD;
&#xD;
          2. Patients with extensive disease small cell lung cancer.&#xD;
&#xD;
          3. Patients who are scheduled to start atezolizumab combination therapy in clinical&#xD;
             practice, based on the atezolizumab package insert and the Optimal Use Promotion&#xD;
             Guideline.&#xD;
&#xD;
          4. Patients who signed informed consent form before enrolling the study. The consent from&#xD;
             a legally acceptable representative is required for the patients with uncertain&#xD;
             capacity of judgments.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        &lt; non-small cell lung cancer cohort&gt; (1) Patients who are unsuitable for enrolment into the&#xD;
        study by the investigator's judgment.&#xD;
&#xD;
        &lt;extensive disease small cell lung cancer cohort&gt;&#xD;
&#xD;
        (1) Patients who are unsuitable for enrolment into the study by the investigator's&#xD;
        judgment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Akihiko GENMA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nippon Medical School Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>J-TAIL-2 study exective office</last_name>
    <phone>+81-3-5804-5045</phone>
    <email>prj-jtail2@eps.co.jp</email>
  </overall_contact>
  <location>
    <facility>
      <name>Akashi Medical Center</name>
      <address>
        <city>Akashi</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hyogo Cancer Center</name>
      <address>
        <city>Akashi</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hyogo Prefectural Amagasaki General Medical Center</name>
      <address>
        <city>Amagasaki</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Asahikawa Medical University Hospital</name>
      <address>
        <city>Asahikawa</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Asahikawa Medical Center</name>
      <address>
        <city>Asahikawa</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Juntendo University Hospital</name>
      <address>
        <city>Bunkyō-Ku</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nippon Medical School Hospital</name>
      <address>
        <city>Bunkyō-Ku</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical And Dental University, Medical Hospital</name>
      <address>
        <city>Bunkyō-Ku</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chiba University Hospital</name>
      <address>
        <city>Chiba</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital</name>
      <address>
        <city>Chuo Ku</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fujisawa City Hospital</name>
      <address>
        <city>Fujisawa</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fukui Prefectural Hospital</name>
      <address>
        <city>Fukui</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fukuoka University Hospital</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kyushu University Hospital</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kyushu Cancer Center</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kyushu Medical Center</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fukushima Medical University Hospital</name>
      <address>
        <city>Fukushima</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Gifu Prefectural General Medical Center</name>
      <address>
        <city>Gifu</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Okinawa National Hospital</name>
      <address>
        <city>Ginowan</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hamamatsu University Hospital</name>
      <address>
        <city>Hamamatsu</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Himeji Medical Center</name>
      <address>
        <city>Himeji</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kansai Medical University Hospital</name>
      <address>
        <city>Hirakata</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hirosaki University Hospital</name>
      <address>
        <city>Hirosaki</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hiroshima City Hiroshima Citizens Hospital</name>
      <address>
        <city>Hiroshima</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hiroshima Prefectural Hospital</name>
      <address>
        <city>Hiroshima</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hiroshima University Hospital</name>
      <address>
        <city>Hiroshima</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Aso Iizuka Hospital</name>
      <address>
        <city>Iizuka</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nippon Medical School Chiba Hokusoh Hospital</name>
      <address>
        <city>Inzai</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tokai University Hospital</name>
      <address>
        <city>Isehara</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Japanese Red Cross Ise Hospital</name>
      <address>
        <city>Ise</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teikyo University Hospital</name>
      <address>
        <city>Itabashi-Ku</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Itami City Hospital</name>
      <address>
        <city>Itami</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Iwakuni Clinical Center</name>
      <address>
        <city>Iwakuni</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Shimane University Hospital</name>
      <address>
        <city>Izumo</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Juntendo University Shizuoka Hospital</name>
      <address>
        <city>Izunokuni</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kagawa University Hospital</name>
      <address>
        <city>Kagawa</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kagoshima University Hospital</name>
      <address>
        <city>Kagoshima</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kameda Medical Center</name>
      <address>
        <city>Kamogawa</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ishikawa Prefectural Central Hospital</name>
      <address>
        <city>Kanazawa</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kanazawa University Hospital</name>
      <address>
        <city>Kanazawa</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ibaraki Prefectural Central Hospital</name>
      <address>
        <city>Kasama</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kasukabe Medical Center</name>
      <address>
        <city>Kasukabe</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kishiwada City Hospital</name>
      <address>
        <city>Kishiwada</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital of the University of Occupational and Envioronmental Health</name>
      <address>
        <city>Kitakyushu</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Japan Community Health care Organization Kyushu Hospital</name>
      <address>
        <city>Kitakyushu</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kitakyushu Municipal Medical Center</name>
      <address>
        <city>Kitakyushu</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Japan Anti-Tuberculosis Association Fukujuji Hospital</name>
      <address>
        <city>Kiyose</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Tokyo National Hospital</name>
      <address>
        <city>Kiyose</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kobe City Medical Center General Hospital</name>
      <address>
        <city>Kobe</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kobe Minimally Invasive Cancer Center</name>
      <address>
        <city>Kobe</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kobe University Hospital</name>
      <address>
        <city>Kobe</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Dokkyo Medical University Saitama Medical Center</name>
      <address>
        <city>Koshigaya</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Cancer Institute Hospital of Japanese Foundation For Cancer Research</name>
      <address>
        <city>Koto-Ku</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kurashiki Central Hospital</name>
      <address>
        <city>Kurashiki</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kure Medical Center and Chugoku Cancer</name>
      <address>
        <city>Kure</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kurume University Hospital</name>
      <address>
        <city>Kurume</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kyoto City Hospital</name>
      <address>
        <city>Kyoto</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kyoto University Hospital</name>
      <address>
        <city>Kyoto</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kyoto-Katsura Hospital</name>
      <address>
        <city>Kyoto</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kyoto Medical Center</name>
      <address>
        <city>Kyoto</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University Hospital, Kyoto Prefectural University of Medicine</name>
      <address>
        <city>Kyoto</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Shinshu University Hospital</name>
      <address>
        <city>Matsumoto</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Matsusaka Municipal Hospital</name>
      <address>
        <city>Matsusaka</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Shikoku Cancer Center</name>
      <address>
        <city>Matsuyama</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Tokyo Medical Center</name>
      <address>
        <city>Meguro-Ku</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Jikei University Hospital</name>
      <address>
        <city>Minato-Ku</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tokyo Saiseikai Central Hospital</name>
      <address>
        <city>Minato-Ku</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kyorin University Hospital</name>
      <address>
        <city>Mitaka</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Miyazaki Prefectural Miyazaki Hospital</name>
      <address>
        <city>Miyazaki</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nagahama City Hospital</name>
      <address>
        <city>Nagahama</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Aichi Medical University Hospital</name>
      <address>
        <city>Nagakute</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nagasaki University Hospital</name>
      <address>
        <city>Nagasaki</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Aichi Cancer Center</name>
      <address>
        <city>Nagoya</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Japanese Red Cross Nagoya Daini Hospital</name>
      <address>
        <city>Nagoya</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nagoya City University Hospital</name>
      <address>
        <city>Nagoya</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nagoya Ekisaikai Hospital</name>
      <address>
        <city>Nagoya</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nagoya University Hospital</name>
      <address>
        <city>Nagoya</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Nagoya Medical Center</name>
      <address>
        <city>Nagoya</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Miyagi Cancer Center</name>
      <address>
        <city>Natori</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Niigata Cancer Center Hospital</name>
      <address>
        <city>Niigata</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Niigata University Medical and Dental Hospital</name>
      <address>
        <city>Niigata</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Hospital of Hyogo College of Medicine</name>
      <address>
        <city>Nishinomiya</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Obihiro Kosei Hospital</name>
      <address>
        <city>Obihiro</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Japanese Red Cross Okayama Hospital</name>
      <address>
        <city>Okayama</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kawasaki Medical School General Medical Center</name>
      <address>
        <city>Okayama</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Okayama Rosai Hospital</name>
      <address>
        <city>Okayama</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Okayama University Hospital</name>
      <address>
        <city>Okayama</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Osaka City General Hospital</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Osaka General Medical Center</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Osaka International Cancer Institute</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Osaka Saiseikai Nakatsu Hospital</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Osaki Citizen Hospital</name>
      <address>
        <city>Osaki</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kitasato University Hospital</name>
      <address>
        <city>Sagamihara</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Saga University Hospital</name>
      <address>
        <city>Saga</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Jichi Medical University Saitama Medical Center</name>
      <address>
        <city>Saitama</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Saitama medical university International medical Center</name>
      <address>
        <city>Saitama</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Saitama Prefectural Cancer Center</name>
      <address>
        <city>Saitama</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Saitama Red Cross Hospital</name>
      <address>
        <city>Saitama</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kinki-Chuo Chest Medical Center</name>
      <address>
        <city>Sakai</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hokkaido University Hospital</name>
      <address>
        <city>Sapporo</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Hokkaido Cancer Center</name>
      <address>
        <city>Sapporo</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sapporo Medical University Hospital</name>
      <address>
        <city>Sapporo</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Teine Keijinkai Hospital</name>
      <address>
        <city>Sapporo</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sendai Kousei Hospital</name>
      <address>
        <city>Sendai</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tohoku Medical And Pharmaceutical University Hospital</name>
      <address>
        <city>Sendai</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tohoku University Hospital</name>
      <address>
        <city>Sendai</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Japanese Red Cross Medical Center</name>
      <address>
        <city>Shibuya-Ku</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Jichi Medical University Hospital</name>
      <address>
        <city>Shimotsuke</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Showa University Hospital</name>
      <address>
        <city>Shinagawa-Ku</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Center Hospital of the National Center for Global Health and Medicine</name>
      <address>
        <city>Shinjuku-Ku</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Keio University Hospital</name>
      <address>
        <city>Shinjuku-Ku</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical University Hospital</name>
      <address>
        <city>Shinjuku-Ku</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Iwate Medical University Hospital</name>
      <address>
        <city>Shiwa-gun</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Shizuoka Cancer Center</name>
      <address>
        <city>Shizuoka</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Shizuoka General Hospital</name>
      <address>
        <city>Shizuoka</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Osaka University Hospital</name>
      <address>
        <city>Suita</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Saiseikai Suita Hospital</name>
      <address>
        <city>Suita</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kagawa Prefectural Central Hospital</name>
      <address>
        <city>Takamatsu</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>JA Toyama Kouseiren Takaoka Hospital</name>
      <address>
        <city>Takaoka</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Takarazuka City Hospital</name>
      <address>
        <city>Takarazuka</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Osaka Medical and Pharmaceutical University Hospital</name>
      <address>
        <city>Takatsuki</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tenri Hospital</name>
      <address>
        <city>Tenri</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Dokkyo Medical University Hospital</name>
      <address>
        <city>Tochigi</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tokushima Prefectural Central Hospital</name>
      <address>
        <city>Tokushima</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tokushima University Hospital</name>
      <address>
        <city>Tokushima</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Toyama Prefectural Central Hospital</name>
      <address>
        <city>Toyama</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fujita Health University Hospital</name>
      <address>
        <city>Toyoake</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Osaka Toneyama Medical Center</name>
      <address>
        <city>Toyonaka</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>TOYOTA Memorial Hospital</name>
      <address>
        <city>Toyota</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tsukuba Medical Center Hospital</name>
      <address>
        <city>Tsukuba</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Tsukuba Hospital</name>
      <address>
        <city>Tsukuba</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ehime University Hospital</name>
      <address>
        <city>Tōon</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Yamaguchi-Ube Medical Center</name>
      <address>
        <city>Ube</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Juntendo University Urayasu Hospital</name>
      <address>
        <city>Urayasu</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Japanese Red Cross Wakayama Medical Center</name>
      <address>
        <city>Wakayama</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Wakayama Medical University Hospital</name>
      <address>
        <city>Wakayama</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kanagawa Cancer Center</name>
      <address>
        <city>Yokohama</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kanagawa Cardiovascular and Respiratory Center</name>
      <address>
        <city>Yokohama</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Yokohama City University Hospital</name>
      <address>
        <city>Yokohama</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Yokohama Municipal Citizen's Hospital</name>
      <address>
        <city>Yokohama</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Yokosuka Kyosai Hospital</name>
      <address>
        <city>Yokosuka</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tottori University Hospital</name>
      <address>
        <city>Yonago</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Oita University Hospital</name>
      <address>
        <city>Yufu</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ogaki Municipal Hospital</name>
      <address>
        <city>Ōgaki</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Oita Prefectural Hospital</name>
      <address>
        <city>Ōita</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kindai University Hospital</name>
      <address>
        <city>Ōsaka-sayama</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Gunma Prefectural Cancer Center</name>
      <address>
        <city>Ōta</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Shiga University of Medical Science Hospital</name>
      <address>
        <city>Ōtsu</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>August 2, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>June 23, 2021</last_update_submitted>
  <last_update_submitted_qc>June 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atezolizumab</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    <mesh_term>Small Cell Lung Carcinoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All IPD that underlie results in a publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>After the end of the study</ipd_time_frame>
  </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/NCT04501497
org study id: J-TAIL-2
nct id: NCT04501497
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a multi-center observational study of atezolizumab combination therapy in patients
      with unresectable, advanced and recurrent non-small cell lung cancer(NSCLC) or extensive
      disease small cell lung cancer(ED-SCLC). 800 patients in NSCLC cohort and 400 patients in
      ED-SCLC cohort will be enrolled in this trial to assess the efficacy and safety of this
      combination.
Primary endpoint: 12 months OS, Secondary endpoints: Overall Survival(OS), 6 months survival
      rate(6mo OS), 12 months survival rate(12mo OS), Progression-Free Survival(PFS), Time to
      treatment failure (TTF), Objective Response Rate(ORR), Disease Control Rate(DCR), Duration of
      Response(DOR) ,Safety and Comprehensive geriatric assessment(G8)
observational model: Cohort
time perspective: Prospective
measure: 12 months survival rate
time frame: Baseline up to 12 Months
description: Percentage of participants alive 12 months after initiation of treatment
measure: Overall Survival
time frame: Up to death (up to 3 years)
description: OS was defined as the time from the first day of study treatment to death due to any cause
measure: 6 moths survival rate
time frame: Up to 6 months
description: Percentage of participants alive 6 months after initiation of treatment
measure: 18 moths survival rate
time frame: Up to 18 months
description: Percentage of participants alive 18 months after initiation of treatment
measure: Progression-Free Survival(PFS)
time frame: Up to disease progression or death whichever occurs first (up to 3 years)
description: PFS based on disease status as evaluated by the investigator in accordance with Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (v1.1)
measure: Time to treatment failure (TTF)
time frame: Up to 3 years
description: TTF was defined as the time from the first day of study treatment to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death
measure: Post-treatment transfer rate
time frame: Up to post-treatment is started (up to 3 years)
description: Rate of patients who received drug therapy for primary disease after study treatment
measure: Objective Response Rate(ORR)
time frame: Up to disease progression or death whichever occurs first (up to 3 years)
description: Percentage of participants with objective response as assessed by the investigator according to RECIST v1.1
measure: Duration of Response(DOR)
time frame: From date of first objective response up to disease progression or death whichever occurs first (up to 3 years)
description: Duration of Response as Assessed by the Investigator According to RECIST v1.1
measure: Disease Control Rate(DCR)
time frame: Up to 3 years
description: Percentage of patients with controled disease as Assessed by the investigator according to RECIST v1.1
measure: Percentage of Participants with adverse events(Adverse Reactions)
time frame: Up to 3 years
description: The incidence of worst-grade adverse events on study as graded by NCI-CTCAE v5.0
measure: Comprehensive geriatric assessment (G8)
time frame: At baseline
description: The G-8 screening tool was developed to identify elderly cancer patients who would benefit from comprehensive geriatric assessment
arm group label: NSCLC cohort (N=800)
description: Patients with locally advanced or metastatic non-small cell lung cancer who are planning to provide Atezolizumab combination thearapy as the most ppropriate medical care
arm group label: ED-SCLC cohort (N=400)
description: Patients with extensive disease small cell lung cancer who are planning to provide Atezolizumab combination thearapy as the most ppropriate medical care
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
last name: Akihiko GENMA
role: Principal Investigator
affiliation: Nippon Medical School Hospital
last name: J-TAIL-2 study exective office
phone: +81-3-5804-5045
email: prj-jtail2@eps.co.jp
facility: 
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country: Japan
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Small Cell Lung Carcinoma
sharing ipd: Yes
ipd description: All IPD that underlie results in a publication
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: After the end of the study