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

Not Applicable

Not yet recruiting

• Conditions: Metastatic Non-small Cell Lung Cancer With MTAP Deletion
• Interventions: Drug: BMS-986504; Drug: Pembrolizumab; Other: Placebo; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Nab-paclitaxel

• Registration Number: NCT07063745
• Lead Sponsor: Bristol-Myers Squibb

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-03
• Study First Submitted QC: 2025-07-03
• Study First Posted: 2025-07-14
• Last Update Submitted: 2025-07-23
• Last Update Posted: 2025-07-28
• Study Start: 2025-10-06
• Primary Completion: 2031-08-12
• Study Completion: 2031-08-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 590

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: BMS-986504 + Pembrolizumab + Chemotherapy	BMS-986504	-
Arm A: BMS-986504 + Pembrolizumab + Chemotherapy	Pembrolizumab	-
Arm A: BMS-986504 + Pembrolizumab + Chemotherapy	Cisplatin	-
Arm A: BMS-986504 + Pembrolizumab + Chemotherapy	Carboplatin	-
Arm A: BMS-986504 + Pembrolizumab + Chemotherapy	Pemetrexed	-
Arm A: BMS-986504 + Pembrolizumab + Chemotherapy	Paclitaxel	-
Arm A: BMS-986504 + Pembrolizumab + Chemotherapy	Nab-paclitaxel	-
Arm B: BMS-986504 + Pembrolizumab + Chemotherapy	BMS-986504	-
Arm B: BMS-986504 + Pembrolizumab + Chemotherapy	Pembrolizumab	-
Arm B: BMS-986504 + Pembrolizumab + Chemotherapy	Cisplatin	-
Arm B: BMS-986504 + Pembrolizumab + Chemotherapy	Carboplatin	-
Arm B: BMS-986504 + Pembrolizumab + Chemotherapy	Pemetrexed	-
Arm B: BMS-986504 + Pembrolizumab + Chemotherapy	Paclitaxel	-
Arm B: BMS-986504 + Pembrolizumab + Chemotherapy	Nab-paclitaxel	-
Arm C: Placebo + Pembrolizumab + Chemotherapy	Pembrolizumab	-
Arm C: Placebo + Pembrolizumab + Chemotherapy	Placebo	-
Arm C: Placebo + Pembrolizumab + Chemotherapy	Cisplatin	-
Arm C: Placebo + Pembrolizumab + Chemotherapy	Carboplatin	-
Arm C: Placebo + Pembrolizumab + Chemotherapy	Pemetrexed	-
Arm C: Placebo + Pembrolizumab + Chemotherapy	Paclitaxel	-
Arm C: Placebo + Pembrolizumab + Chemotherapy	Nab-paclitaxel	-
Arm D: Placebo + Pembrolizumab + Chemotherapy	Pembrolizumab	-
Arm D: Placebo + Pembrolizumab + Chemotherapy	Placebo	-
Arm D: Placebo + Pembrolizumab + Chemotherapy	Cisplatin	-
Arm D: Placebo + Pembrolizumab + Chemotherapy	Carboplatin	-
Arm D: Placebo + Pembrolizumab + Chemotherapy	Pemetrexed	-
Arm D: Placebo + Pembrolizumab + Chemotherapy	Paclitaxel	-
Arm D: Placebo + Pembrolizumab + Chemotherapy	Nab-paclitaxel	-
Arm E: BMS-986504 + Pembrolizumab + Chemotherapy	BMS-986504	-
Arm E: BMS-986504 + Pembrolizumab + Chemotherapy	Pembrolizumab	-
Arm E: BMS-986504 + Pembrolizumab + Chemotherapy	Cisplatin	-
Arm E: BMS-986504 + Pembrolizumab + Chemotherapy	Carboplatin	-
Arm E: BMS-986504 + Pembrolizumab + Chemotherapy	Pemetrexed	-
Arm E: BMS-986504 + Pembrolizumab + Chemotherapy	Paclitaxel	-
Arm E: BMS-986504 + Pembrolizumab + Chemotherapy	Nab-paclitaxel	-
Arm F: Placebo + Pembrolizumab + Chemotherapy	Pembrolizumab	-
Arm F: Placebo + Pembrolizumab + Chemotherapy	Placebo	-
Arm F: Placebo + Pembrolizumab + Chemotherapy	Cisplatin	-
Arm F: Placebo + Pembrolizumab + Chemotherapy	Carboplatin	-
Arm F: Placebo + Pembrolizumab + Chemotherapy	Pemetrexed	-
Arm F: Placebo + Pembrolizumab + Chemotherapy	Paclitaxel	-
Arm F: Placebo + Pembrolizumab + Chemotherapy	Nab-paclitaxel	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	Up to 2 years
Overall Survival (OS)	Up to 5 years	Phase 3

Secondary Outcome Measures

Name	Time	Method
Objective response (OR) (confirmed complete response (CR) or partial response (PR))	Up to 2 years	Phase 2
Disease control (best overall response (BOR) of confirmed CR, confirmed PR, or stable disease (SD))	Up to 2 years	Phase 2
Time to objective response (TTOR) (CR or PR)	Up to 2 years	Phase 2
Duration of response (DOR) (CR or PR)	Up to 2 years	Phase 2
OR (confirmed CR or PR)	Up to 5 years	Phase 3
Disease control (BOR of confirmed CR, confirmed PR, or SD)	Up to 5 years	Phase 3
DOR (CR or PR)	Up to 5 years	Phase 3
PFS	Up to 5 years

Trial Locations

Locations (215)

Local Institution - 0388; 🇺🇸 Phoenix, Arizona, United States

Local Institution - 0389; 🇺🇸 Jacksonville, Florida, United States

Local Institution - 0182; 🇺🇸 Rochester, Minnesota, United States

Local Institution - 0348; 🇺🇸 Portland, Oregon, United States

Local Institution - 0374; 🇺🇸 El Paso, Texas, United States

Local Institution - 0377; 🇺🇸 The Woodlands, Texas, United States

Local Institution - 0072; 🇨🇳 Hefei, Anhui, China

Local Institution - 0074; 🇨🇳 Beijing, Beijing, China

Local Institution - 0049; 🇨🇳 Beijing, Beijing, China

Local Institution - 0286; 🇨🇳 Beijing, Beijing, China

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