Phase 2
Completed N=1
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
Source: ClinicalTrials.gov NCT05005273 ↗Enrolled (actual)
1
Serious AEs
100.0%
Results posted
Feb 2024
Primary outcomePrimary: Progression Free Survival by BICR
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival by BICR |
— | — |
| SECONDARY Progression Free Survival by Investigator |
2.3 | — |
| SECONDARY Overall Response Rate (ORR) by BICR |
— | — |
| SECONDARY Overall Response Rate (ORR) by Investigator |
— | — |
| SECONDARY Duration of Response (DOR) by Investigator |
NA | — |
| SECONDARY Overall Survival (OS) |
2.3 | — |
| SECONDARY Number of Participants Who Had AEs, SAEs, AEs Leading to Discontinuation and Deaths. |
0; 0; 1; 0; 0; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT05005273). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.