RecruitingInterventionalPhase 2/Phase 3

A Randomized Phase 2/3 Study of Navlimetostat (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

NCT ID: NCT07063745Sponsor: Bristol-Myers SquibbLast updated: 2026-06-05

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

Arms & 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
DrugNab-paclitaxel
Specified dose on specified days

Outcome measures

Primary

Progression-free survival (PFS) by RECIST v1.1
Phase 2
Time frame: Up to 2 years
PFS by RECIST v1.1 per BICR
Phase 3
Time frame: Up to 5 years
Overall Survival (OS)
Phase 3
Time frame: Up to 5 years

Secondary

Objective response (OR) (confirmed complete response (CR) or partial response (PR))
Time frame: Up to 2 years
Disease control (best overall response (BOR) of confirmed CR, confirmed PR, or stable disease (SD))
Time frame: Up to 2 years
Duration of response (DOR) (CR or PR)
Time frame: Up to 2 years
Time to objective response (TTOR) (CR or PR)
Time frame: Up to 2 years
Number of participants with treatment-related and all-cause adverse events (AEs)
Time frame: Up to 90 days from the last dose
Number of participants with serious adverse events (SAEs) including fatal AEs
Time frame: Up to 90 days from the last dose
Number of participants with adverse events leading to dose interruption, dose reduction, and study treatment discontinuation
Time frame: Up to 90 days from the last dose
Number of participants with laboratory abnormalities
Time frame: Up to 90 days from the last dose
OR (confirmed CR or PR)
Time frame: Up to 5 years
Disease control (BOR of confirmed CR, confirmed PR, or SD)
Time frame: Up to 5 years
DOR (CR or PR)
Time frame: Up to 5 years
PFS by RECIST v1.1 per Investigator
Time frame: Up to 5 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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 * Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy. * Participants must not have symptomatic brain metastases or spinal cord compression. * Participants must not have any prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for metastatic non-small cell lung cancer (mNSCLC). Note: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated. * Participants must not have any known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing. * Other protocol-defined Inclusion/Exclusion criteria apply.

Study locations (42)

Alaska Oncology and Hematology

Anchorage, Alaska, 99508

Recruiting

Steven Liu, Site 0119 · Contact

907-257-9851

Mayo Clinic in Arizona - Phoenix

Phoenix, Arizona, 85054

Recruiting

Vinicius Ernani, Site 0388 · Contact

480-342-4800

University of Arizona Cancer Center

Tucson, Arizona, 85724

Recruiting

Ricklie Julian, Site 0120 · Contact

850-557-2723

Highlands Oncology Group

Springdale, Arkansas, 72762

Recruiting

Eric Schaefer, Site 0135 · Contact

479-872-8130

Local Institution - 0497

Los Alamitos, California, 90720

Not Yet Recruiting

Site 0497 · Contact

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033

Recruiting

Robert Hsu, Site 0407 · Contact

323-865-3000

Local Institution - 0444

Los Angeles, California, 90067

Withdrawn

Local Institution - 0606

Newark, Delaware, 19713

Not Yet Recruiting

Site 0606 · Contact

Helios Clinical Research - Fort Lauderdale

Fort Lauderdale, Florida, 33316

Recruiting

Edgardo Santos, Site 0152 · Contact

239-938-9315

Mayo Clinic in Florida

Jacksonville, Florida, 32224

Recruiting

Shenduo Li, Site 0389 · Contact

904-953-0315

Local Institution - 0430

St. Petersburg, Florida, 33709

Withdrawn

St. Luke's Cancer Institute: Boise

Boise, Idaho, 83712

Recruiting

Sri Harsha Tella, Site 0124 · Contact

Local Institution - 0605

Decatur, Illinois, 62526

Not Yet Recruiting

Site 0605 · Contact

Baptist Health Lexington

Lexington, Kentucky, 40503

Recruiting

Firas Badin, Site 0333 · Contact

859-260-6100

University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536

Recruiting

John Villano, Site 0125 · Contact

859-323-6522

Local Institution - 0127

Scarborough, Maine, 04074

Not Yet Recruiting

Site 0127 · Contact

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting

Pasi Janne, Site 0158 · Contact

617-632-6036

Local Institution - 0418

Ann Arbor, Michigan, 48109

Not Yet Recruiting

Site 0418 · Contact

Local Institution - 0405

Detroit, Michigan, 48201

Not Yet Recruiting

Site 0405 · Contact

Local Institution - 0420

Traverse City, Michigan, 49684

Not Yet Recruiting

Site 0420 · Contact

Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota, 55905

Recruiting

Konstantinos Leventakos, Site 0182 · Contact

507-284-2511

Oncology Hematology West P.C. dba Nebraska Cancer Specialists

Omaha, Nebraska, 68130

Recruiting

Geetha Palaniappan, Site 0160 · Contact

402-593-3141

Local Institution - 0467

Lebanon, New Hampshire, 03756

Not Yet Recruiting

Site 0467 · Contact

Local Institution - 0600

Manchester, New Hampshire, 03103

Not Yet Recruiting

Site 0600 · Contact

WMCHealth Advanced Physician Services

Hawthorne, New York, 10532

Recruiting

Marjorie Zauderer, Site 0179 · Contact

914-493-8375

Local Institution - 0128

Rochester, New York, 14642

Not Yet Recruiting

Site 0128 · Contact

Local Institution - 0518

Schenectady, New York, 12308

Not Yet Recruiting

Site 0518 · Contact

Local Institution - 0514

Winston-Salem, North Carolina, 27157

Not Yet Recruiting

Site 0514 · Contact

Local Institution - 0163

Cleveland, Ohio, 44195

Withdrawn

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

Recruiting

Timothy Burns, Site 0129 · Contact

412-864-7859

Providence Portland Medical Center

Portland, Oregon, 97213

Recruiting

Rachel Sanborn, Site 0164 · Contact

503-215-5696

Kaiser Permanente Interstate Medical Office Central

Portland, Oregon, 97227

Recruiting

Sandeep Mashru, Site 0348 · Contact

503-249-3315

Local Institution - 0608

Greenville, South Carolina, 29607

Not Yet Recruiting

Site 0608 · Contact

Local Institution - 0515

Knoxville, Tennessee, 37920

Not Yet Recruiting

Site 0515 · Contact

Local Institution - 0433

Dallas, Texas, 75390

Not Yet Recruiting

Site 0433 · Contact

Renovatio Clinical - El Paso

El Paso, Texas, 79915

Recruiting

Mary Crow, Site 0374 · Contact

713-703-2398

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting

Natalie Vokes, Site 0132 · Contact

000-000-0000

Local Institution - 0377

The Woodlands, Texas, 77380

Withdrawn

Huntsman Cancer Institute

Salt Lake City, Utah, 84112

Recruiting

Matthew Gumbleton, Site 0354 · Contact

801-587-4557

Local Institution - 0131

Fairfax, Virginia, 22031

Withdrawn

Virginia Commonwealth University

Richmond, Virginia, 23219

Recruiting

Renato Martins, Site 0186 · Contact

804-828-7999

Fred Hutchinson Cancer Center

Seattle, Washington, 98109

Recruiting

Lei Deng, Site 0145 · Contact

206-606-4801