<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/NCT04500535</url>
  </required_header>
  <id_info>
    <org_study_id>CA209-7HX</org_study_id>
    <nct_id>NCT04500535</nct_id>
  </id_info>
  <brief_title>A Study of Participants With Advanced Non-Small Cell Lung Cancer Treated With Nivolumab in France After at Least One Prior Chemotherapy-based Treatment by Lung Initiative on Sequence Therapy</brief_title>
  <acronym>LIST</acronym>
  <official_title>A Multi-Center, Longitudinal, Prospective, Observational, Multi-Cohort Study of Patients With Advanced Non-Small Cell Lung Cancer Treated With Nivolumab in France After at Least One Prior Chemotherapy-based Treatment (LIST, Lung Initiative on Sequence Therapy)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bristol-Myers Squibb</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this trial is to describe the following, for each cohort, in real world&#xD;
      conditions in France:&#xD;
&#xD;
        -  The characteristics and treatment sequence of patients treated with nivolumab&#xD;
&#xD;
        -  The effectiveness of nivolumab treatment&#xD;
&#xD;
        -  The safety profile of nivolumab&#xD;
&#xD;
        -  Treatment patterns (e.g. duration of treatment, subsequent treatments) of nivolumab&#xD;
&#xD;
        -  The patient-reported outcomes (PRO) in patients treated with nivolumab, at baseline and&#xD;
           during follow up using the EuroQoL-5D-3L&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 28, 2020</start_date>
  <completion_date type="Anticipated">September 15, 2025</completion_date>
  <primary_completion_date type="Anticipated">September 15, 2025</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>Time to treatment failure (TTF)</measure>
    <time_frame>Up to 3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>Up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>Up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to next therapy (TTNT)</measure>
    <time_frame>Up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best overall response rate (BORR)</measure>
    <time_frame>Up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of participant demographics characteristics: Age</measure>
    <time_frame>Index date (treatment initiation date for each individual patient</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of participant demographics characteristics: Sex</measure>
    <time_frame>Index date (treatment initiation date for each individual patient)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of clinical characteristics: Smoking status</measure>
    <time_frame>Index date (treatment initiation date for each individual patient)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of clinical characteristics: ECOG at initial diagnosis and at nivolumab initiation</measure>
    <time_frame>Index date (treatment initiation date for each individual patient)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of clinical characteristics: Histology</measure>
    <time_frame>Index date (treatment initiation date for each individual patient)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of clinical characteristics: TNM classification</measure>
    <time_frame>Index date (treatment initiation date for each individual patient)</time_frame>
    <description>TNM=Tumor Nodes Metastases</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of clinical characteristics: Location of metastases</measure>
    <time_frame>Index date (treatment initiation date for each individual patient)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of clinical characteristics: EGFR mutation</measure>
    <time_frame>Index date (treatment initiation date for each individual patient)</time_frame>
    <description>EGRF=Epidural Growth Factor Receptor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of clinical characteristics: ALK translocation</measure>
    <time_frame>Index date (treatment initiation date for each individual patient)</time_frame>
    <description>ALK= Anaplastic Lymphoma Kinase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of clinical characteristics: HER2 mutation</measure>
    <time_frame>Index date (treatment initiation date for each individual patient)</time_frame>
    <description>HER2=Human Epidermal Growth Factor Receptor 2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of clinical characteristics: BRAF mutation</measure>
    <time_frame>Index date (treatment initiation date for each individual patient)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of clinical characteristics: KRAS mutation</measure>
    <time_frame>Index date (treatment initiation date for each individual patient)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of clinical characteristics: ROS1 mutation</measure>
    <time_frame>Index date (treatment initiation date for each individual patient)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of clinical characteristics: MET mutation</measure>
    <time_frame>Index date (treatment initiation date for each individual patient)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of clinical characteristics: PD-L1 expression</measure>
    <time_frame>Index date (treatment initiation date for each individual patient)</time_frame>
    <description>PD-L1=Programmed Death Ligand 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of clinical characteristics: PD-L1 expression on tumor or stromal cells</measure>
    <time_frame>Index date (treatment initiation date for each individual patient)</time_frame>
    <description>PD-L1=Programmed Death Ligand 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Adverse Drug Reactions</measure>
    <time_frame>36 months after nivolumab treatment initiation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Seriousness criteria</measure>
    <time_frame>36 months after nivolumab treatment initiation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Intensity/ Grade</measure>
    <time_frame>36 months after nivolumab treatment initiation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of AE duration</measure>
    <time_frame>Follow-up period (Week 4 to Week 156)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Action taken regarding the BMS treatment</measure>
    <time_frame>Follow-up period (Week 4 to Week 156)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Incidence rate</measure>
    <time_frame>Follow-up period (Week 4 to Week 156)</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">698</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <description>Immuno-oncology (IO)-naïve patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <description>IO-experienced patients for whom last IO discontinuation was not primarily related to IO-toxicity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3</arm_group_label>
    <description>IO-experienced patients for whom last IO discontinuation was primarily due to IO-toxicity</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The target population will be constituted using multistage sampling, in which physicians&#xD;
        (pulmonologists and/or oncologists) from eligible hospitals are to identify and recruit the&#xD;
        participants. Eligible hospitals will be selected among PMSI sites (national hospital&#xD;
        discharge database) and only hospitals with a minimum of 40 patients treated for lung&#xD;
        cancer and with chemotherapy in 2018 will be considered to ensure sufficient enrollment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please&#xD;
        visit www.BMSStudyConnect.com&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathologically confirmed diagnosis of advanced NSCLC&#xD;
&#xD;
          -  Whose physician has already decided to initiate a treatment with nivolumab for the&#xD;
             treatment of advanced NSCLC according to the European label&#xD;
&#xD;
          -  Previously treated with at least one prior chemotherapy- containing regimen&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants taking part in an interventional study for lung cancer treatment for&#xD;
             which nivolumab is one of the investigational drugs&#xD;
&#xD;
          -  Participants with a diagnosis of another primary cancer within the past five years&#xD;
&#xD;
          -  Participants receiving IO within 12 weeks prior to nivolumab first infusion in the&#xD;
             context of the present study&#xD;
&#xD;
        Other protocol-defined inclusion/exclusion criteria apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</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 - 0001</name>
      <address>
        <city>Paris Cedex 5</city>
        <zip>75248</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</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>May 2023</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>May 19, 2023</last_update_submitted>
  <last_update_submitted_qc>May 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Non Small Cell Lung Cancer</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>
  </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/NCT04500535
org study id: CA209-7HX
nct id: NCT04500535
lead sponsor: 
has dmc: Yes
is fda regulated device: No
The purpose of this trial is to describe the following, for each cohort, in real world
      conditions in France:

        -  The characteristics and treatment sequence of patients treated with nivolumab

        -  The effectiveness of nivolumab treatment

        -  The safety profile of nivolumab

        -  Treatment patterns (e.g. duration of treatment, subsequent treatments) of nivolumab

        -  The patient-reported outcomes (PRO) in patients treated with nivolumab, at baseline and
           during follow up using the EuroQoL-5D-3L
observational model: Cohort
time perspective: Prospective
measure: Time to treatment failure (TTF)
time frame: Up to 3 years
measure: Overall survival (OS)
time frame: Up to 3 years
measure: Progression-free survival (PFS)
time frame: Up to 3 years
measure: Time to next therapy (TTNT)
time frame: Up to 3 years
measure: Best overall response rate (BORR)
time frame: Up to 3 years
measure: Distribution of participant demographics characteristics: Age
time frame: Index date (treatment initiation date for each individual patient
measure: Distribution of participant demographics characteristics: Sex
time frame: Index date (treatment initiation date for each individual patient)
measure: Distribution of clinical characteristics: Smoking status
time frame: Index date (treatment initiation date for each individual patient)
measure: Distribution of clinical characteristics: ECOG at initial diagnosis and at nivolumab initiation
time frame: Index date (treatment initiation date for each individual patient)
measure: Distribution of clinical characteristics: Histology
time frame: Index date (treatment initiation date for each individual patient)
measure: Distribution of clinical characteristics: TNM classification
time frame: Index date (treatment initiation date for each individual patient)
description: TNM=Tumor Nodes Metastases
measure: Distribution of clinical characteristics: Location of metastases
time frame: Index date (treatment initiation date for each individual patient)
measure: Distribution of clinical characteristics: EGFR mutation
time frame: Index date (treatment initiation date for each individual patient)
description: EGRF=Epidural Growth Factor Receptor
measure: Distribution of clinical characteristics: ALK translocation
time frame: Index date (treatment initiation date for each individual patient)
description: ALK= Anaplastic Lymphoma Kinase
measure: Distribution of clinical characteristics: HER2 mutation
time frame: Index date (treatment initiation date for each individual patient)
description: HER2=Human Epidermal Growth Factor Receptor 2
measure: Distribution of clinical characteristics: BRAF mutation
time frame: Index date (treatment initiation date for each individual patient)
measure: Distribution of clinical characteristics: KRAS mutation
time frame: Index date (treatment initiation date for each individual patient)
measure: Distribution of clinical characteristics: ROS1 mutation
time frame: Index date (treatment initiation date for each individual patient)
measure: Distribution of clinical characteristics: MET mutation
time frame: Index date (treatment initiation date for each individual patient)
measure: Distribution of clinical characteristics: PD-L1 expression
time frame: Index date (treatment initiation date for each individual patient)
description: PD-L1=Programmed Death Ligand 1
measure: Distribution of clinical characteristics: PD-L1 expression on tumor or stromal cells
time frame: Index date (treatment initiation date for each individual patient)
description: PD-L1=Programmed Death Ligand 1
measure: Incidence of Adverse Drug Reactions
time frame: 36 months after nivolumab treatment initiation
measure: Incidence of Seriousness criteria
time frame: 36 months after nivolumab treatment initiation
measure: Incidence of Intensity/ Grade
time frame: 36 months after nivolumab treatment initiation
measure: Incidence of AE duration
time frame: Follow-up period (Week 4 to Week 156)
measure: Incidence of Action taken regarding the BMS treatment
time frame: Follow-up period (Week 4 to Week 156)
measure: Incidence of Incidence rate
time frame: Follow-up period (Week 4 to Week 156)
arm group label: Cohort 1
description: Immuno-oncology (IO)-naïve patients
arm group label: Cohort 2
description: IO-experienced patients for whom last IO discontinuation was not primarily related to IO-toxicity
arm group label: Cohort 3
description: IO-experienced patients for whom last IO discontinuation was primarily due to IO-toxicity
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
facility: 
country: France
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