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
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether adding navlimetostat (BMS-986504) to pembrolizumab and chemotherapy works better than adding a placebo (a treatment with no active drug). It is for people starting treatment for non-small cell lung cancer that has spread and has both copies of the MTAP gene missing or has MTAP loss.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have non-small cell lung cancer that has spread (stage IV or cancer that has come back), with no prior whole-body cancer treatment for the spread.
- Have a diagnosis confirmed by a tissue test, with both copies of the MTAP gene missing or MTAP loss.
- Be fully active or able to do light work, even if hard physical activity is limited.
- Have at least one cancer spot that can be measured.
Who can't join
- For people with the nonsquamous type of lung cancer: have a gene change with an available standard treatment used as the first treatment.
- Have cancer that has spread to the brain and causes symptoms, or pressure on the spinal cord.
- Have already had whole-body treatment for lung cancer that has spread, such as chemotherapy, immune therapy, or targeted therapy. One cycle of standard treatment may be allowed before study group assignment if treatment is needed right away.
- Have a known or suspected problem with the stomach or intestines that could prevent absorbing medicine or swallowing it without chewing or crushing.
- Other study rules also apply.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (44)
AK
- Local Institution - 0119 · Anchorage, AK 99508More trials in Anchorage
AR
- Highlands Oncology Group · Springdale, AR 72762Eric Schaefer, Site 0135 · Study contact · 479-872-8130More trials in Springdale
AZ
- Mayo Clinic in Arizona - Phoenix · Phoenix, AZ 85054Vinicius Ernani, Site 0388 · Study contact · 480-342-4800More trials in Phoenix
- University of Arizona Cancer Center · Tucson, AZ 85724Ricklie Julian, Site 0120 · Study contact · 850-557-2723More trials in Tucson
CA
- Local Institution - 0497 · Los Alamitos, CA 90720Site 0497 · Study contactMore trials in Los Alamitos
- USC/Norris Comprehensive Cancer Center · Los Angeles, CA 90033Robert Hsu, Site 0407 · Study contact · 323-865-3000More trials in Los Angeles
- Local Institution - 0444 · Los Angeles, CA 90067More trials in Los Angeles
DE
- Local Institution - 0606 · Newark, DE 19713More trials in Newark
FL
- Helios Clinical Research - Fort Lauderdale · Fort Lauderdale, FL 33316Edgardo Santos, Site 0152 · Study contact · 239-938-9315More trials in Fort Lauderdale
- Mayo Clinic in Florida · Jacksonville, FL 32224Shenduo Li, Site 0389 · Study contact · 904-953-0315More trials in Jacksonville
- Local Institution - 0430 · St. Petersburg, FL 33709More trials in St. Petersburg
- Local Institution - 0523 · Tampa, FL 33612Site 0523 · Study contactMore trials in Tampa
ID
- St. Luke's Cancer Institute: Boise · Boise, ID 83712Sri Harsha Tella, Site 0124 · Study contactMore trials in Boise
IL
- Local Institution - 0605 · Decatur, IL 62526Site 0605 · Study contactMore trials in Decatur
KY
- Baptist Health Lexington · Lexington, KY 40503Firas Badin, Site 0333 · Study contact · 859-260-6100More trials in Lexington
- University of Kentucky Chandler Medical Center · Lexington, KY 40536John Villano, Site 0125 · Study contact · 859-323-6522More trials in Lexington
MA
- Dana-Farber Cancer Institute · Boston, MA 02215Pasi Janne, Site 0158 · Study contact · 617-632-6036More trials in Boston
ME
- Local Institution - 0127 · Scarborough, ME 04074Site 0127 · Study contactMore trials in Scarborough
MI
- Local Institution - 0418 · Ann Arbor, MI 48109Site 0418 · Study contactMore trials in Ann Arbor
- Local Institution - 0405 · Detroit, MI 48201Site 0405 · Study contactMore trials in Detroit
- Local Institution - 0420 · Traverse City, MI 49684Site 0420 · Study contactMore trials in Traverse City
MN
- Mayo Clinic in Rochester, Minnesota · Rochester, MN 55905Konstantinos Leventakos, Site 0182 · Study contact · 507-284-2511More trials in Rochester
NC
- Local Institution - 0514 · Winston-Salem, NC 27157Site 0514 · Study contactMore trials in Winston-Salem
NE
- Oncology Hematology West P.C. dba Nebraska Cancer Specialists · Omaha, NE 68130Geetha Palaniappan, Site 0160 · Study contact · 402-593-3141More trials in Omaha
NH
- Local Institution - 0467 · Lebanon, NH 03756Site 0467 · Study contactMore trials in Lebanon
- Local Institution - 0600 · Manchester, NH 03103Site 0600 · Study contactMore trials in Manchester
NY
- WMCHealth Advanced Physician Services · Hawthorne, NY 10532Marjorie Zauderer, Site 0179 · Study contact · 914-493-8375More trials in Hawthorne
- Local Institution - 0128 · Rochester, NY 14642Site 0128 · Study contactMore trials in Rochester
- Local Institution - 0518 · Schenectady, NY 12308Site 0518 · Study contactMore trials in Schenectady
OH
- Local Institution - 0163 · Cleveland, OH 44195More trials in Cleveland
- The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center · Columbus, OH 43210Timothy Burns, Site 0129 · Study contact · 412-864-7859More trials in Columbus
OR
- Providence Portland Medical Center · Portland, OR 97213Rachel Sanborn, Site 0164 · Study contact · 503-215-5696More trials in Portland
- Kaiser Permanente Interstate Medical Office Central · Portland, OR 97227Sandeep Mashru, Site 0348 · Study contact · 503-249-3315More trials in Portland
PA
- Local Institution - 0559 · Hershey, PA 17033More trials in Hershey
SC
- Local Institution - 0608 · Greenville, SC 29607Site 0608 · Study contactMore trials in Greenville
TN
- Local Institution - 0515 · Knoxville, TN 37920More trials in Knoxville
TX
- Local Institution - 0433 · Dallas, TX 75390Site 0433 · Study contactMore trials in Dallas
- Local Institution - 0374 · El Paso, TX 79915More trials in El Paso
- University of Texas MD Anderson Cancer Center · Houston, TX 77030Natalie Vokes, Site 0132 · Study contact · 000-000-0000More trials in Houston
- Local Institution - 0377 · The Woodlands, TX 77380More trials in The Woodlands
UT
- Huntsman Cancer Institute · Salt Lake City, UT 84112Matthew Gumbleton, Site 0354 · Study contact · 801-587-4557More trials in Salt Lake City
VA
- Local Institution - 0131 · Fairfax, VA 22031More trials in Fairfax
- Virginia Commonwealth University · Richmond, VA 23219Renato Martins, Site 0186 · Study contact · 804-828-7999More trials in Richmond
WA
- Fred Hutchinson Cancer Center · Seattle, WA 98109Lei Deng, Site 0145 · Study contact · 206-606-4801More trials in Seattle