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

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Metastatic Non-small Cell Lung Cancer With MTAP Deletion

In brief

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

Key facts

Study ID

NCT07063745

Run by

Bristol-Myers Squibb

People needed

590

Starts

2026-01-02

Expected to finish

2031-08-12

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Instituto Alexander Fleming — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina (enrolling)
• The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (enrolling)
• Renovatio Clinical - El Paso — El Paso, Texas, United States (enrolling)
• Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)
• Hospital Británico de Buenos Aires — CABA, Buenos Aires, Argentina (enrolling)
• Alaska Oncology and Hematology — Anchorage, Alaska, United States (enrolling)
• WMCHealth Advanced Physician Services — Hawthorne, New York, United States (enrolling)
• Kaiser Permanente Interstate Medical Office Central — Portland, Oregon, United States (enrolling)
• Mayo Clinic in Arizona - Phoenix — Phoenix, Arizona, United States (enrolling)
• Virginia Commonwealth University — Richmond, Virginia, United States (enrolling)
• St. Luke's Cancer Institute: Boise — Boise, Idaho, United States (enrolling)
• University of Arizona Cancer Center — Tucson, Arizona, United States (enrolling)
• Baptist Health Lexington — Lexington, Kentucky, United States (enrolling)
• University of Kentucky Chandler Medical Center — Lexington, Kentucky, United States (enrolling)
• Highlands Oncology Group — Springdale, Arkansas, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Helios Clinical Research - Fort Lauderdale — Fort Lauderdale, Florida, United States (enrolling)
• Mayo Clinic in Florida — Jacksonville, Florida, United States (enrolling)
• Providence Portland Medical Center — Portland, Oregon, United States (enrolling)
• Mayo Clinic in Rochester, Minnesota — Rochester, Minnesota, United States (enrolling)
• Oncology Hematology West P.C. dba Nebraska Cancer Specialists — Omaha, Nebraska, United States (enrolling)
• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
• Huntsman Cancer Institute — Salt Lake City, Utah, United States (enrolling)
• Centro Oncologico Korben — Buenos Aires, Argentina (enrolling)

Full record on ClinicalTrials.gov

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