<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/NCT03804554</url>
  </required_header>
  <id_info>
    <org_study_id>CA209-8MH</org_study_id>
    <nct_id>NCT03804554</nct_id>
  </id_info>
  <brief_title>A Study of Participants in Australia Who Have Non-small Cell Lung Cancer Being Treated With Nivolumab</brief_title>
  <official_title>Nivolumab in the Treatment of Patients With Non-small Cell Lung Cancer: The Australian Experience</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to capture and describe the patient and disease characteristics and the&#xD;
      outcomes of adult patients with previously-treated advanced NSCLC who have been treated with&#xD;
      Nivolumab&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 3, 2018</start_date>
  <completion_date type="Actual">August 12, 2021</completion_date>
  <primary_completion_date type="Actual">August 12, 2021</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>Time to treatment failure (TTF)</measure>
    <time_frame>Approximately 27 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Best overall response (BOR)</measure>
    <time_frame>Approximately 27 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival rate (PFSR)</measure>
    <time_frame>Approximately 27 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival rate (OSR)</measure>
    <time_frame>Approximately 27 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of AE's</measure>
    <time_frame>Approximately 27 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of SAE's</measure>
    <time_frame>Approximately 27 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reasons for ceasing treatment</measure>
    <time_frame>Approximately 27 months</time_frame>
    <description>Any of the following: progressive disease, toxicity, patient wishes/preference, doctor decision, death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of patients with brain metastases</measure>
    <time_frame>Approximately 27 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of re-treatment</measure>
    <time_frame>Approximately 27 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">503</enrollment>
  <condition>Non-Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Patients taking nivolumab</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-Interventional</intervention_name>
    <description>Non-Interventional</description>
    <arm_group_label>Patients taking nivolumab</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Previously-treated advanced NSCLC patients commencing treatment with nivolumab between May&#xD;
        2015 and August 2017 under the Australian Patient Access Program&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Adult male or female (≥18 years of age) patients with NSCLC&#xD;
&#xD;
          -  Treated with nivolumab on the Australian PAP&#xD;
&#xD;
          -  Initiated Nivolumab between May 2015 and August 2017&#xD;
&#xD;
          -  Attending clinician agreeable to provide patient data&#xD;
&#xD;
          -  Local institutional ethics requirements satisfied&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Insufficient data available&#xD;
&#xD;
        Other protocol defined inclusion/exclusion criteria could apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Heidelburg</city>
        <state>Victoria</state>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</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>http://www.fda.gov/safety/medwatch/safetyinformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>November 12, 2018</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</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 27, 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/NCT03804554
org study id: CA209-8MH
nct id: NCT03804554
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is to capture and describe the patient and disease characteristics and the
      outcomes of adult patients with previously-treated advanced NSCLC who have been treated with
      Nivolumab
observational model: Cohort
time perspective: Retrospective
measure: Time to treatment failure (TTF)
time frame: Approximately 27 months
measure: Best overall response (BOR)
time frame: Approximately 27 months
measure: Progression free survival rate (PFSR)
time frame: Approximately 27 months
measure: Overall survival rate (OSR)
time frame: Approximately 27 months
measure: Incidence of AE's
time frame: Approximately 27 months
measure: Incidence of SAE's
time frame: Approximately 27 months
measure: Reasons for ceasing treatment
time frame: Approximately 27 months
description: Any of the following: progressive disease, toxicity, patient wishes/preference, doctor decision, death
measure: Incidence of patients with brain metastases
time frame: Approximately 27 months
measure: Incidence of re-treatment
time frame: Approximately 27 months
arm group label: Patients taking nivolumab
intervention type: Other
intervention name: Non-Interventional
description: Non-Interventional
arm group label: Patients taking nivolumab
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
facility: 
country: Australia
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: http://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