<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/NCT03770299</url>
  </required_header>
  <id_info>
    <org_study_id>CA209-9TN</org_study_id>
    <secondary_id>2018-003719-23</secondary_id>
    <nct_id>NCT03770299</nct_id>
  </id_info>
  <brief_title>An Investigational Immuno-therapy Study of Nivolumab Given After Surgery in Non-Small Cell Lung Cancer (NSCLC) Participants With Minimal Residual Disease</brief_title>
  <acronym>CheckMate 9TN</acronym>
  <official_title>A Phase 2 Multi-Center Randomized Trial to Assess Early Intervention With Adjuvant Nivolumab in Non-Small Cell Lung Cancer Participants With ctDNA-detected Minimal Residual Disease After Surgical Resection</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>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if nivolumab added to the standard of care therapy&#xD;
      (SOC) given after surgery is more effective than SOC alone in prolonging disease free&#xD;
      survival in NSCLC participants with minimal residual disease detected after surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Business objectives have changed&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 15, 2021</start_date>
  <completion_date type="Anticipated">March 14, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 14, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disease-free survival (DFS)</measure>
    <time_frame>Approximately 24 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Circulating tumor DNA (ctDNA) response rate</measure>
    <time_frame>Approximately 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ctDNA duration of response (DOR)</measure>
    <time_frame>Approximately 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ctDNA time to response (TTR)</measure>
    <time_frame>Approximately 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events (AEs)</measure>
    <time_frame>Approximately 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of serious adverse events (SAEs)</measure>
    <time_frame>Approximately 36 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Non-Small Cell Lung Cancer</condition>
  <condition>Non-Small-Cell Lung Carcinoma</condition>
  <condition>Circulating Tumor DNA</condition>
  <arm_group>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nivolumab + SOC (chemotherapy in eligible participants or observation)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SOC (chemotherapy in eligible participants or observation)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Arm A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vinorelbine</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pemetrexed</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observation</intervention_name>
    <description>Observation by the investigator</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria prior to Surgery:&#xD;
&#xD;
          -  Suspected or histologically confirmed Stage IIA to IIIB NSCLC with disease that is&#xD;
             considered resectable&#xD;
&#xD;
          -  Must be deemed eligible for complete resection and must agree to undergo standard of&#xD;
             care surgery for complete resection of NSCLC&#xD;
&#xD;
          -  Treatment naive (no previous systemic treatment)&#xD;
&#xD;
        Inclusion Criteria prior to Treatment Randomization:&#xD;
&#xD;
          -  Must have undergone complete surgical resection of their Stage IIA to IIIB NSCLC&#xD;
&#xD;
          -  Must have adequately recovered from surgery at the time of randomization&#xD;
&#xD;
          -  Minimal residual disease (MRD) positive results as detected by ctDNA&#xD;
&#xD;
        Exclusion Criteria prior to Surgery:&#xD;
&#xD;
          -  Participants with known EGFR mutations which are sensitive to available targeted&#xD;
             inhibitor therapy (Prior to treatment randomization in select sites)&#xD;
&#xD;
          -  Active, known or suspected autoimmune disease&#xD;
&#xD;
          -  Participants with a condition requiring systemic treatment with either corticosteroids&#xD;
             (&gt; 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14&#xD;
             days of randomization&#xD;
&#xD;
        Exclusion Criteria prior to Treatment Randomization:&#xD;
&#xD;
          -  Must continue to meet Exclusion Criteria prior to Surgery&#xD;
&#xD;
          -  Must have no evidence of metastatic disease after surgery&#xD;
&#xD;
          -  Received a live/attenuated vaccine within 30 days of first treatment&#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>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <removed_countries>
    <country>Germany</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </removed_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.bmsstudyconnect.com/s/US/English/USenHome</url>
    <description>BMS Clinical Trial Patient Recruiting</description>
  </link>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>Investigator Inquiry Form</description>
  </link>
  <link>
    <url>https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>March 9, 2022</last_update_submitted>
  <last_update_submitted_qc>March 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 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>
    <mesh_term>Neoplasm, Residual</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Vinorelbine</mesh_term>
    <mesh_term>Docetaxel</mesh_term>
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Gemcitabine</mesh_term>
    <mesh_term>Nivolumab</mesh_term>
    <mesh_term>Pemetrexed</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual patient level data from this study may be shared with qualified researchers, upon request, following the timelines and process detailed on https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html</ipd_description>
  </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/NCT03770299
org study id: CA209-9TN
secondary id: 2018-003719-23
nct id: NCT03770299
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to determine if nivolumab added to the standard of care therapy
      (SOC) given after surgery is more effective than SOC alone in prolonging disease free
      survival in NSCLC participants with minimal residual disease detected after surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Disease-free survival (DFS)
time frame: Approximately 24 months
measure: Circulating tumor DNA (ctDNA) response rate
time frame: Approximately 36 months
measure: ctDNA duration of response (DOR)
time frame: Approximately 36 months
measure: ctDNA time to response (TTR)
time frame: Approximately 36 months
measure: Incidence of adverse events (AEs)
time frame: Approximately 36 months
measure: Incidence of serious adverse events (SAEs)
time frame: Approximately 36 months
arm group label: Arm A
arm group type: Experimental
description: Nivolumab + SOC (chemotherapy in eligible participants or observation)
arm group label: Arm B
arm group type: Active Comparator
description: SOC (chemotherapy in eligible participants or observation)
intervention type: Biological
intervention name: Nivolumab
description: Specified dose on specified days
arm group label: Arm A
intervention type: Drug
intervention name: Vinorelbine
description: Specified dose on specified days
arm group label: Arm A
arm group label: Arm B
intervention type: Drug
intervention name: Gemcitabine
description: Specified dose on specified days
arm group label: Arm A
arm group label: Arm B
intervention type: Drug
intervention name: Docetaxel
description: Specified dose on specified days
arm group label: Arm A
arm group label: Arm B
intervention type: Drug
intervention name: Pemetrexed
description: Specified dose on specified days
arm group label: Arm A
arm group label: Arm B
intervention type: Drug
intervention name: Cisplatin
description: Specified dose on specified days
arm group label: Arm A
arm group label: Arm B
intervention type: Drug
intervention name: Carboplatin
description: Specified dose on specified days
arm group label: Arm A
arm group label: Arm B
intervention type: Drug
intervention name: Paclitaxel
description: Specified dose on specified days
arm group label: Arm A
arm group label: Arm B
intervention type: Other
intervention name: Observation
description: Observation by the investigator
arm group label: Arm A
arm group label: Arm B
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
country: Germany
country: Switzerland
country: United Kingdom
country: United States
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: https://www.bmsstudyconnect.com/s/US/English/USenHome
description: BMS Clinical Trial Patient Recruiting
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: Investigator Inquiry Form
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
mesh term: Neoplasm, Residual
mesh term: Paclitaxel
mesh term: Vinorelbine
mesh term: Docetaxel
mesh term: Carboplatin
mesh term: Gemcitabine
mesh term: Nivolumab
mesh term: Pemetrexed
sharing ipd: Yes
ipd description: Individual patient level data from this study may be shared with qualified researchers, upon request, following the timelines and process detailed on https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html