A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Ch
The purpose of this study is to compare the clinical benefit of the combination of Navlimetostat (BMS-986504) (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer participants with homo
| Condition(s) | Metastatic Non-small Cell Lung Cancer With MTAP Deletion |
|---|---|
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Study type | Interventional |
| Summary | The purpose of this study is to compare the clinical benefit of the combination of Navlimetostat (BMS-986504) (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer participants with homozygous MTAP deletion |
| Who can participate | Inclusion Criteria * Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease. * Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss. * Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Participants must have at least 1 measurable lesion as per RECIST v1.1. Exclusion Criteria * Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy. * Part |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Bristol-Myers Squibb |
| Locations | Anchorage, Alaska, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Springdale, Arkansas, United States; Los Alamitos, California, United States; Los Angeles, California, United States (+305 more sites) |
| Start date | 2026-01-02 |
| NCT ID | NCT07063745 |
| Official listing | https://clinicaltrials.gov/study/NCT07063745 |