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 · NCT07063745 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 26 US states.
- Local Institution - 0119 - Anchorage, Alaska, United States
- Mayo Clinic in Arizona - Phoenix - Phoenix, Arizona, United States
- University of Arizona Cancer Center - Tucson, Arizona, United States
- Highlands Oncology Group - Springdale, Arkansas, United States
- Local Institution - 0497 - Los Alamitos, California, United States
- USC/Norris Comprehensive Cancer Center - Los Angeles, California, United States
- Local Institution - 0444 - Los Angeles, California, United States
- Local Institution - 0606 - Newark, Delaware, United States
- Helios Clinical Research - Fort Lauderdale - Fort Lauderdale, Florida, United States
- Mayo Clinic in Florida - Jacksonville, Florida, United States
- Local Institution - 0430 - St. Petersburg, Florida, United States
- Local Institution - 0523 - Tampa, Florida, United States
- St. Luke's Cancer Institute: Boise - Boise, Idaho, United States
- Local Institution - 0605 - Decatur, Illinois, United States
- Baptist Health Lexington - Lexington, Kentucky, United States
- University of Kentucky Chandler Medical Center - Lexington, Kentucky, United States
- Local Institution - 0127 - Scarborough, Maine, United States
- Dana-Farber Cancer Institute - Boston, Massachusetts, United States
- Local Institution - 0418 - Ann Arbor, Michigan, United States
- Local Institution - 0405 - Detroit, Michigan, United States
- Local Institution - 0420 - Traverse City, Michigan, United States
- Mayo Clinic in Rochester, Minnesota - Rochester, Minnesota, United States
- Oncology Hematology West P.C. dba Nebraska Cancer Specialists - Omaha, Nebraska, United States
- Local Institution - 0467 - Lebanon, New Hampshire, United States
- Local Institution - 0600 - Manchester, New Hampshire, United States
- WMCHealth Advanced Physician Services - Hawthorne, New York, United States
- Local Institution - 0128 - Rochester, New York, United States
- Local Institution - 0518 - Schenectady, New York, United States
- Local Institution - 0514 - Winston-Salem, North Carolina, United States
- Local Institution - 0163 - Cleveland, Ohio, United States
- The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center - Columbus, Ohio, United States
- Providence Portland Medical Center - Portland, Oregon, United States
- Kaiser Permanente Interstate Medical Office Central - Portland, Oregon, United States
- Local Institution - 0559 - Hershey, Pennsylvania, United States
- Local Institution - 0608 - Greenville, South Carolina, United States
- Local Institution - 0515 - Knoxville, Tennessee, United States
- Local Institution - 0433 - Dallas, Texas, United States
- Local Institution - 0374 - El Paso, Texas, United States
- University of Texas MD Anderson Cancer Center - Houston, Texas, United States
- Local Institution - 0377 - The Woodlands, Texas, United States
- Huntsman Cancer Institute - Salt Lake City, Utah, United States
- Local Institution - 0131 - Fairfax, Virginia, United States
- Virginia Commonwealth University - Richmond, Virginia, United States
- Fred Hutchinson Cancer Center - Seattle, Washington, United States
- Adana Medical Park Seyhan Hastanesi - Adana, Turkey (Türkiye)
- Local Institution - 0317 - Adana, Turkey (Türkiye)
- Liv Hospital Ankara - Ankara, Turkey (Türkiye)
- Local Institution - 0593 - Ankara, Turkey (Türkiye)
- Local Institution - 0350 - Antalya, Turkey (Türkiye)
- Local Institution - 0566 - Antofagasta, Chile
- Local Institution - 0230 - Arnhem, Netherlands
- Local Institution - 0198 - Berlin, Germany
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola - Bologna, Italy
- UZ Brussel - Brussels, Belgium
- Centrul de Diagnostic si Tratament Provita - Bucharest, Romania
- Local Institution - 0288 - Budapest, Hungary
- Centro Oncologico Korben - Buenos Aires, Argentina
- Local Institution - 0472 - Buenos Aires, Argentina
- Uludag Universitesi - Bursa, Turkey (Türkiye)
- Centrum Onkologii im. Prof. Franciszka Lukaszczyka - Bydgoszcz, Poland
Showing 60 of 320 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →