Trials / Recruiting
RecruitingNCT07063745
A Study to Compare the Combination of BMS-986504 With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion
A Randomized Phase 2/3 Study of BMS-986504 in Combination With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion
- Status
- Recruiting
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 590 (estimated)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare the clinical benefit of the combination of 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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BMS-986504 | Specified dose on specified days |
| DRUG | Pembrolizumab | Specified dose on specified days |
| OTHER | Placebo | Specified dose on specified days |
| DRUG | Cisplatin | Specified dose on specified days |
| DRUG | Carboplatin | Specified dose on specified days |
| DRUG | Pemetrexed | Specified dose on specified days |
| DRUG | Paclitaxel | Specified dose on specified days |
| DRUG | Nab-paclitaxel | Specified dose on specified days |
Timeline
- Start date
- 2026-01-02
- Primary completion
- 2031-08-12
- Completion
- 2031-08-12
- First posted
- 2025-07-14
- Last updated
- 2026-04-07
Locations
264 sites across 33 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, China, Colombia, Czechia, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Poland, Romania, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07063745. Inclusion in this directory is not an endorsement.