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Clinical Trials in the UK / NCT07063745
Recruiting Phase 2/Phase 3

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

NCT07063745 · tracked via the Priya Life Science UK tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 2/Phase 3
Started
2026-01-02
Last updated
2026-09-14

Condition(s) studied

Metastatic Non-small Cell Lung Cancer With MTAP Deletion

Investigational drug(s) / intervention(s)

BMS-986504PembrolizumabPlaceboCisplatinCarboplatinPemetrexedPaclitaxelNab-paclitaxel

BMS-986504: Specified dose on specified days

Pembrolizumab: Specified dose on specified days

Placebo: Specified dose on specified days

Cisplatin: Specified dose on specified days

Carboplatin: Specified dose on specified days

Pemetrexed: Specified dose on specified days

Paclitaxel: Specified dose on specified days

Nab-paclitaxel: Specified dose on specified days

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
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 * 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.

Primary outcome measure(s)

Trial sites (321)

FacilityCityRegionStatus
Local Institution - 0119 Anchorage Alaska Completed
Mayo Clinic in Arizona - Phoenix Phoenix Arizona Recruiting
University of Arizona Cancer Center Tucson Arizona Recruiting
Highlands Oncology Group Springdale Arkansas Recruiting
Local Institution - 0497 Los Alamitos California Not Yet Recruiting
USC/Norris Comprehensive Cancer Center Los Angeles California Recruiting
Local Institution - 0444 Los Angeles California Withdrawn
Local Institution - 0606 Newark Delaware Withdrawn
Helios Clinical Research - Fort Lauderdale Fort Lauderdale Florida Recruiting
Mayo Clinic in Florida Jacksonville Florida Recruiting
Local Institution - 0430 St. Petersburg Florida Withdrawn
Local Institution - 0523 Tampa Florida Not Yet Recruiting
St. Luke's Cancer Institute: Boise Boise Idaho Recruiting
Local Institution - 0605 Decatur Illinois Not Yet Recruiting
Baptist Health Lexington Lexington Kentucky Recruiting
University of Kentucky Chandler Medical Center Lexington Kentucky Recruiting
Local Institution - 0127 Scarborough Maine Not Yet Recruiting
Dana-Farber Cancer Institute Boston Massachusetts Recruiting
Local Institution - 0418 Ann Arbor Michigan Not Yet Recruiting
Local Institution - 0405 Detroit Michigan Not Yet Recruiting
Local Institution - 0420 Traverse City Michigan Not Yet Recruiting
Mayo Clinic in Rochester, Minnesota Rochester Minnesota Recruiting
Oncology Hematology West P.C. dba Nebraska Cancer Specialists Omaha Nebraska Recruiting
Local Institution - 0467 Lebanon New Hampshire Not Yet Recruiting
Local Institution - 0600 Manchester New Hampshire Not Yet Recruiting
WMCHealth Advanced Physician Services Hawthorne New York Recruiting
Local Institution - 0128 Rochester New York Not Yet Recruiting
Local Institution - 0518 Schenectady New York Not Yet Recruiting
Local Institution - 0514 Winston-Salem North Carolina Not Yet Recruiting
Local Institution - 0163 Cleveland Ohio Withdrawn
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center Columbus Ohio Recruiting
Providence Portland Medical Center Portland Oregon Recruiting
Kaiser Permanente Interstate Medical Office Central Portland Oregon Recruiting
Local Institution - 0559 Hershey Pennsylvania Withdrawn
Local Institution - 0608 Greenville South Carolina Not Yet Recruiting
Local Institution - 0515 Knoxville Tennessee Withdrawn
Local Institution - 0433 Dallas Texas Not Yet Recruiting
Local Institution - 0374 El Paso Texas Completed
University of Texas MD Anderson Cancer Center Houston Texas Recruiting
Local Institution - 0377 The Woodlands Texas Withdrawn

+ 281 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07063745 on ClinicalTrials.gov ↗ ← All trials in the UK