CA240-0029: BMS-986504 + Pembrolizumab + Chemo in 1L Metastatic NSCLC with Homozygous MTAP Deletion
Research type
Research Study
Full title
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
IRAS ID
1009225
Contact name
GSMCT Representative
Contact email
Sponsor organisation
Bristol-Myers Squibb Services Unlimited Company
ISRCTN Number
-
Research summary
This study is evaluating the safety and effectiveness of a new drug, BMS-986504, in combination with pembrolizumab and chemotherapy versus a placebo combined with pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer (NSCLC) patients who have a specific genetic mutation in the tumour called homozygous MTAP deletion. The study aims to determine whether BMS-986504 can benefit patients who have not previously received systemic anti-cancer therapy for metastatic lung cancer by assessing how the drug works, its effects on the body, and its overall safety. Homozygous MTAP deletion occurs in about 13% of NSCLC patients, making it a relatively rare mutation.
This study will include adults aged 18 years or older who have been diagnosed with first-line metastatic NSCLC with homozygous MTAP deletion. Participants will be randomly divided into four treatment groups in Phase 2: Arm A (BMS-986504 Dose Level 1 plus pembrolizumab and chemotherapy), Arm B (BMS-986504 Dose Level 2 plus pembrolizumab and chemotherapy), Arm C (Dose Level 1 Matching Placebo plus pembrolizumab and chemotherapy), and Arm D (Dose Level 2 Matching Placebo plus pembrolizumab and chemotherapy). In Phase 3, participants will be divided into Arm E (selected dose of BMS-986504 plus pembrolizumab and chemotherapy) and Arm F (matching placebo plus pembrolizumab and chemotherapy).
About 590 participants will take part in this study worldwide, including participants in the UK. The study will take place at multiple locations.
Participants will complete up to three study periods: a screening period (up to 28 days), a treatment period (21-day cycles) as long as they are benefiting from treatment and do not have unacceptable side effects, and a follow-up period, which includes a safety visit 28 days after the last dose of BMS-986504, 90 days after the last pembrolizumab dose and survival follow-ups every 3 months.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
25/LO/0563
Date of REC Opinion
26 Sep 2025
REC opinion
Further Information Favourable Opinion