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Active, Not Recruiting

A Study to Assess BMS-986207 in Combination With Nivolumab and Ipilimumab as First-line Treatment for Participants With Stage IV Non-Small Cell Lung Cancer - CA020-016

Updated: 20 January, 2023   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
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

    Phase

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Arm A
Drug: Nivolumab Drug: BMS-986207 Drug: Ipilimumab
Experimental: Arm B
Drug: Nivolumab Other: Placebo Drug: Ipilimumab

Key Eligibility Criteria

Inclusion Criteria: - Histologically confirmed metastatic 1L Stage IV non-small cell lung cancer (NSCLC) of squamous or nonsquamous histology - No prior systemic anti-cancer treatment given as primary therapy for advanced or metastatic NSCLC - Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - A formalin-fixed, paraffin-embedded (FFPE) tumor tissue block or a minimum of 20 unstained slides of tumor tissue obtained during screening or prior to enrollment - Life expectancy of at least 3 months at the time of first dose Exclusion Criteria: - Participants with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or c-ros oncogene 1 (ROS-1) mutations which are sensitive to available targeted inhibitor therapy. Participants with nonsquamous histology and unknown EGFR, ALK, or ROS-1 status are also excluded - Participants with known B-rapidly accelerated fibrosarcoma proto-oncogene (BRAF) V600E mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown or indeterminate BRAF mutation status are eligible. - Untreated central nervous system metastases - Leptomeningeal metastases (carcinomatous meningitis) - Concurrent malignancy requiring treatment - Active, known, or suspected autoimmune disease - Interstitial lung disease - Uncontrolled or significant cardiovascular disease Other protocol-defined inclusion/exclusion criteria apply

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