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
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Progression-free survival (PFS) by RECIST v1.1 — Up to 2 years
Phase 2 - PFS by RECIST v1.1 per BICR — Up to 5 years
Phase 3 - Overall Survival (OS) — Up to 5 years
Phase 3
Trial sites (321)
| Facility | City | Region | Status |
|---|---|---|---|
| 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| Local Institution - 0444 | Los Angeles | California | Withdrawn |
| Local Institution - 0606 | Newark | Delaware | Withdrawn |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| Local Institution - 0430 | St. Petersburg | Florida | Withdrawn |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.
On this site
📄 Keytruda (pembrolizumab) drug profile →More Bristol-Myers Squibb trials in Australia
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 Australia