<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/NCT03273790</url>
  </required_header>
  <id_info>
    <org_study_id>CA209-9CR</org_study_id>
    <nct_id>NCT03273790</nct_id>
  </id_info>
  <brief_title>A Retrospective Study of the Effectiveness and Safety of Nivolumab in Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients in Japan</brief_title>
  <official_title>Effectiveness and Safety of Nivolumab in Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients - Retrospective Study of Japanese Real-World Data Through Clinical Chart Review</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ono Pharmaceutical Co. Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Bristol-Myers Squibb</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Retrospective Study of the Effectiveness and Safety of Nivolumab in Advanced/Metastatic&#xD;
      Non-Small Cell Lung Cancer (NSCLC) Patients in Japan&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Description of clinical usage of nivolumab in previously treated NSCLC patients</measure>
    <time_frame>Approximately 9 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Approximately 9 months</time_frame>
    <description>Measured from time of initial diagnosis and treatment with nivolumab until date of death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>Approximately 9 months</time_frame>
    <description>Time since index date (initial diagnosis and treatment with nivolumab) to either the first disease progression date or last known tumor assessment date, or death due to any cause, whichever occurs first</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients receiving bi-weekly nivolumab</measure>
    <time_frame>Approximately 9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients receiving monotherapy or combination therapy</measure>
    <time_frame>Approximately 9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients receiving nivolumab as second or later line of therapy</measure>
    <time_frame>Approximately 9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median treatment duration and range by line and histology</measure>
    <time_frame>Approximately 9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of permanent and temporary discontinuations</measure>
    <time_frame>Approximately 9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reasons for discontinuation of nivolumab</measure>
    <time_frame>Approximately 9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reasons for re-challenge of nivolumab</measure>
    <time_frame>Approximately 9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR) as assessed by investigator</measure>
    <time_frame>Approximately 9 months</time_frame>
    <description>ORR is defined as the number of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the total number of participants who received treatment</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">939</enrollment>
  <condition>Non-Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>NSCLC patients</arm_group_label>
    <description>Initiated Nivolumab treatment at least once from 01 Apr. 2016 through 31 Dec. 2016</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Previously treated advanced/metastatic NSCLC patients treated with nivolumab in Japan.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Previously treated advanced/metastatic NSCLC patients treated with nivolumab at least&#xD;
             once from 01-Apr-2016 through 31-Dec-2016&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients who meets the inclusion criteria will be included in the analysis to describe&#xD;
        real-world clinical usage of nivolumab. However, patients treated with nivolumab falling in&#xD;
        following criteria will be excluded for analysis for the other primary endpoint; overall&#xD;
        effectiveness:&#xD;
&#xD;
          -  History of participation in any clinical trials prior- or post-nivolumab treatment&#xD;
&#xD;
          -  Patients who are a part of a Post-marketing surveillance study&#xD;
&#xD;
        Other protocol defined inclusion/exclusion criteria could apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Minato-ku</city>
        <state>Tokyo</state>
        <zip>1050001</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>BMS Clinical Trial Information</description>
  </link>
  <link>
    <url>https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>January 20, 2022</last_update_submitted>
  <last_update_submitted_qc>January 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 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>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <!-- 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/NCT03273790
org study id: CA209-9CR
nct id: NCT03273790
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated device: No
A Retrospective Study of the Effectiveness and Safety of Nivolumab in Advanced/Metastatic
      Non-Small Cell Lung Cancer (NSCLC) Patients in Japan
observational model: Cohort
time perspective: Retrospective
measure: Description of clinical usage of nivolumab in previously treated NSCLC patients
time frame: Approximately 9 months
measure: Overall Survival (OS)
time frame: Approximately 9 months
description: Measured from time of initial diagnosis and treatment with nivolumab until date of death
measure: Progression Free Survival (PFS)
time frame: Approximately 9 months
description: Time since index date (initial diagnosis and treatment with nivolumab) to either the first disease progression date or last known tumor assessment date, or death due to any cause, whichever occurs first
measure: Percentage of patients receiving bi-weekly nivolumab
time frame: Approximately 9 months
measure: Percentage of patients receiving monotherapy or combination therapy
time frame: Approximately 9 months
measure: Percentage of patients receiving nivolumab as second or later line of therapy
time frame: Approximately 9 months
measure: Median treatment duration and range by line and histology
time frame: Approximately 9 months
measure: Rate of permanent and temporary discontinuations
time frame: Approximately 9 months
measure: Reasons for discontinuation of nivolumab
time frame: Approximately 9 months
measure: Reasons for re-challenge of nivolumab
time frame: Approximately 9 months
measure: Objective Response Rate (ORR) as assessed by investigator
time frame: Approximately 9 months
description: ORR is defined as the number of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the total number of participants who received treatment
arm group label: NSCLC patients
description: Initiated Nivolumab treatment at least once from 01 Apr. 2016 through 31 Dec. 2016
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
facility: 
country: Japan
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung