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

Completed · Phase 2 · Has a placebo group

Conditions studied: Non-Small Cell Lung Cancer

In brief

The purpose of this study is to determine the safety and efficacy of BMS-986207 in combination with nivolumab and ipilimumab as first-line treatment for participants with stage IV non-small cell lung cancer (NSCLC).

Key facts

Study ID

NCT05005273

Run by

Bristol-Myers Squibb

People needed

1

Starts

2022-10-03

Expected to finish

2022-12-27

Last updated by the study team

2024-02-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution - 0051 — Fountain Valley, California, United States
• Local Institution - 0070 — Fort Myers, Florida, United States
• Local Institution - 0073 — Gainesville, Florida, United States
• Local Institution - 0036 — Orange City, Florida, United States
• Local Institution - 0045 — Pensacola, Florida, United States
• Local Institution — Port Saint Lucie, Florida, United States
• Local Institution - 0068 — St. Petersburg, Florida, United States
• Local Institution — Tallahassee, Florida, United States
• Local Institution — West Palm Beach, Florida, United States
• Local Institution - 0081 — Boise, Idaho, United States
• Local Institution - 0077 — Coeur d'Alene, Idaho, United States
• Local Institution - 0074 — Edgewood, Kentucky, United States
• Local Institution - 0002 — Ann Arbor, Michigan, United States
• Local Institution - 0049 — Brooklyn, New York, United States
• Local Institution - 0012 — Charleston, South Carolina, United States
• Local Institution - 0053 — Milwaukee, Wisconsin, United States
• Local Institution - 0009 — Pergamino, Buenos Aires, Argentina
• Local Institution - 0054 — Rosario, Santa Fe Province, Argentina
• Local Institution - 0062 — Buenos Aires, Argentina
• Local Institution - 0021 — Buenos Aires, Argentina
• Local Institution - 0011 — Buenos Aires, Argentina
• Local Institution - 0048 — Buenos Aires, Argentina
• Local Institution - 0057 — San Juan, Argentina
• Local Institution - 0063 — Orange, New South Wales, Australia
• Local Institution - 0080 — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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