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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
Sponsor: Bristol-Myers Squibb
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
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
590
Start Date
2026-01-02
Completion Date
2031-08-12
Last Updated
2026-10-23
Healthy Volunteers
No
Interventions
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
Locations (321)
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
Cancer Care Specialists of Illinois - Cancer Care Center of O'Fallon
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
UT Southwestern Medical Center Simmons Comprehensive Cancer Center
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
Hospital Británico de Buenos Aires
CABA, Buenos Aires, Argentina
Instituto Alexander Fleming
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0477
Río Cuarto, Córdoba Province, Argentina
Local Institution - 0568
Lujan de Cuyo, Mendoza Province, Argentina
Local Institution - 0627
Lujan de Cuyo, Mendoza Province, Argentina
Fundacion Estudios Clinicos
Rosario, Santa Fe Province, Argentina
Sanatorio Plaza
Rosario, Santa Fe Province, Argentina
Centro Oncologico Korben
Buenos Aires, Argentina
Local Institution - 0472
Buenos Aires, Argentina
Local Institution - 0432
Liverpool, New South Wales, Australia
GenesisCare St Leonards
St Leonards, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Grampians Health
Ballarat Central, Victoria, Australia
Local Institution - 0368
Garran, Australia
Ordensklinikum Linz GmbH Elisabethinen
Linz, Upper Austria, Austria
Landeskrankenhaus Rankweil
Rankweil, Austria
Klinik Floridsdorf
Vienna, Austria
Antwerp University Hospital
Edegem, Antwerpen, Belgium
Local Institution - 0225
Yvoir, Namur, Belgium
AZ Delta vzw
Roeselare, West-Vlaanderen, Belgium
UZ Brussel
Brussels, Belgium
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège, Belgium
Pronutrir
Fortaleza, Ceará, Brazil
CEDOES
Vitória, Espírito Santo, Brazil
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, Brazil
Unimed Porto Alegre
Porto Alegre, Rio Grande Do Sil, Brazil
Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul, Brazil
Instituto de Oncologia Saint Gallen
Santa Cruz do Sul, Rio Grande do Sul, Brazil
Clínica de Oncologia Reichow
Blumenau, Santa Catarina, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, Brazil
NAIC - Instituto do Câncer
Bauru, São Paulo, Brazil
Centro de Pesquisa Sao Lucas
Campinas, São Paulo, Brazil
Centro de Oncologia - CEON+ - Unidade São Caetano do Sul
São Caetano do Sul, São Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, Brazil
A. C. Camargo Cancer Center
São Paulo, São Paulo, Brazil
Instituto Nacional de Câncer - INCA
Rio de Janeiro, Brazil
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, Brazil
Local Institution - 0315
Panagyurishte, Pazardzhik, Bulgaria
Specialized Hospital for Active Treatment of Oncology - Haskovo
Haskovo, Bulgaria
Complex Oncology Center - Ruse EOOD
Rousse, Bulgaria
University Multidisciplinary Hospital for Active Treatment "St. Ekaterina"
Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna-ISUL" EAD
Sofia, Bulgaria
Trakia Hospital
Stara Zagora, Bulgaria
Local Institution - 0473
Providencia, Santiago Metropolitan, Chile
Local Institution - 0476
Recoleta, Santiago Metropolitan, Chile
Local Institution - 0566
Antofagasta, Chile
Local Institution - 0475
Santiago, Chile
Local Institution - 0072
Hefei, Anhui, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Local Institution - 0049
Beijing, Beijing Municipality, China
Local Institution - 0286
Beijing, Beijing Municipality, China
Local Institution - 0621
Beijing, Beijing Municipality, China
Local Institution - 0108
Chongqing, Chongqing Municipality, China