A Study to Compare the Combination of Navlimetostat (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
NCT07063745 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 590
Last updated 2026-05-18
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
Conditions
- Metastatic Non-small Cell Lung Cancer With MTAP Deletion
Interventions
- DRUG
-
BMS-986504
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- OTHER
-
Placebo
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Pemetrexed
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Specified dose on specified days
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-02
- Primary Completion
- 2031-08-12
- Completion
- 2031-08-12
- FDA Drug
- Yes
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
Study Locations
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