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
Bristol-Myers Squibb
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
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 * Nonsqu…
Interventions
- DrugBMS-986504
Specified dose on specified days
- DrugPembrolizumab
Specified dose on specified days
- OtherPlacebo
Specified dose on specified days
- DrugCisplatin
Specified dose on specified days
- DrugCarboplatin
Specified dose on specified days
- DrugPemetrexed
Specified dose on specified days
- DrugPaclitaxel
Specified dose on specified days
Locations (277)
- Alaska Oncology and HematologyAnchorage, Alaska
- Mayo Clinic in Arizona - PhoenixPhoenix, Arizona
- Local Institution - 0120Tucson, Arizona
- Highlands Oncology GroupSpringdale, Arkansas
- Local Institution - 0497Los Alamitos, California
- USC/Norris Comprehensive Cancer CenterLos Angeles, California