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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

Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 2


  • Gender(s)

  • 18+

    Age Range

  • 10


  • Not Yet Recruiting

Treatment Options

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

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

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

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