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Not Yet Recruiting

An Investigational Immuno-therapy Study of Nivolumab Given After Surgery in Non-Small Cell Lung Cancer (NSCLC) Participants With Minimal Residual Disease - CA209-9TN

Updated: 23 September, 2019   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
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Trial Details

  • Phase 2

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 10

    Location(s)

  • Not Yet Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Arm A
Other: Observation Drug: Paclitaxel Drug: Carboplatin Drug: Cisplatin Drug: Pemetrexed Drug: Docetaxel Drug: Gemcitabine Drug: Vinorelbine Biological: Nivolumab
Active Comparator: Arm B
Other: Observation Drug: Paclitaxel Drug: Carboplatin Drug: Cisplatin Drug: Pemetrexed Drug: Docetaxel Drug: Gemcitabine Drug: Vinorelbine

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria prior to Surgery: - Suspected or histologically confirmed Stage IIA to IIIB NSCLC with disease that is considered resectable - Must be deemed eligible for complete resection and must agree to undergo standard of care surgery for complete resection of NSCLC - Treatment naive (no previous systemic treatment) Inclusion Criteria prior to Treatment Randomization: - Must have undergone complete surgical resection of their Stage IIA to IIIB NSCLC - Must have adequately recovered from surgery at the time of randomization - Minimal residual disease (MRD) positive results as detected by ctDNA Exclusion Criteria prior to Surgery: - Participants with known EGFR mutations which are sensitive to available targeted inhibitor therapy (Prior to treatment randomization in select sites) - Active, known or suspected autoimmune disease - Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization Exclusion Criteria prior to Treatment Randomization: - Must continue to meet Exclusion Criteria prior to Surgery - Must have no evidence of metastatic disease after surgery - Received a live/attenuated vaccine within 30 days of first treatment Other protocol defined inclusion/exclusion criteria could apply

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Side Effects (Adverse Events) and other reportable events are defined here
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Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com