A Randomized Phase 2/3 Study of 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
Status: Recruiting
Location: See all (262) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
The purpose of this study is to compare the clinical benefit of the combination of 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alaska
Alaska Oncology and Hematology
RECRUITING
Anchorage
Arkansas
Highlands Oncology Group
RECRUITING
Springdale
Arizona
Mayo Clinic in Arizona - Phoenix
RECRUITING
Phoenix
Local Institution - 0120
NOT_YET_RECRUITING
Tucson
California
Local Institution - 0444
NOT_YET_RECRUITING
Los Angeles
USC/Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
Florida
Local Institution - 0152
NOT_YET_RECRUITING
Fort Lauderdale
Mayo Clinic in Florida
RECRUITING
Jacksonville
Local Institution - 0430
WITHDRAWN
St. Petersburg
Idaho
St. Luke's Cancer Institute: Boise
RECRUITING
Boise
Kentucky
Baptist Health Lexington
RECRUITING
Lexington
University of Kentucky Chandler Medical Center
RECRUITING
Lexington
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Maine
Local Institution - 0127
NOT_YET_RECRUITING
Scarborough
Michigan
Local Institution - 0418
NOT_YET_RECRUITING
Ann Arbor
Local Institution - 0405
NOT_YET_RECRUITING
Detroit
Local Institution - 0420
NOT_YET_RECRUITING
Traverse City
Minnesota
Mayo Clinic in Rochester, Minnesota
RECRUITING
Rochester
Nebraska
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
RECRUITING
Omaha
New Hampshire
Local Institution - 0467
NOT_YET_RECRUITING
Lebanon
New York
Local Institution - 0179
NOT_YET_RECRUITING
Hawthorne
Local Institution - 0128
NOT_YET_RECRUITING
Rochester
Ohio
Local Institution - 0163
NOT_YET_RECRUITING
Cleveland
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
Oregon
Kaiser Permanente Interstate Medical Office Central
RECRUITING
Portland
Providence Portland Medical Center
RECRUITING
Portland
Texas
Local Institution - 0433
NOT_YET_RECRUITING
Dallas
Local Institution - 0374
NOT_YET_RECRUITING
El Paso
University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Local Institution - 0377
WITHDRAWN
The Woodlands
Utah
Huntsman Cancer Institute
RECRUITING
Salt Lake City
Virginia
Local Institution - 0131
WITHDRAWN
Fairfax
Local Institution - 0186
NOT_YET_RECRUITING
Richmond
Washington
Fred Hutchinson Cancer Center
RECRUITING
Seattle
Other Locations
Argentina
Local Institution - 0446
NOT_YET_RECRUITING
Buenos Aires
Local Institution - 0447
NOT_YET_RECRUITING
Buenos Aires
Local Institution - 0465
NOT_YET_RECRUITING
Ciudad Autónoma De Buenos Aires
Local Institution - 0463
NOT_YET_RECRUITING
Rosario
Australia
Grampians Health
RECRUITING
Ballarat Central
Sunshine Coast University Hospital
RECRUITING
Birtinya
Lyell McEwin Hospital
RECRUITING
Elizabeth Vale
Local Institution - 0368
NOT_YET_RECRUITING
Garran
Local Institution - 0431
NOT_YET_RECRUITING
Hobart
Local Institution - 0432
NOT_YET_RECRUITING
Liverpool
Local Institution - 0373
NOT_YET_RECRUITING
Woolloongabba
Austria
Ordensklinikum Linz GmbH Elisabethinen
RECRUITING
Linz
Landeskrankenhaus Rankweil
RECRUITING
Rankweil
Local Institution - 0207
NOT_YET_RECRUITING
Vienna
Belgium
UZ Brussel
RECRUITING
Brussels
Antwerp University Hospital
RECRUITING
Edegem
Local Institution - 0226
NOT_YET_RECRUITING
Hasselt
Local Institution - 0340
NOT_YET_RECRUITING
Liège
AZ Delta vzw
RECRUITING
Roeselare
Local Institution - 0225
NOT_YET_RECRUITING
Yvoir
Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
RECRUITING
Barretos
NAIC - Instituto do Câncer
RECRUITING
Bauru
Local Institution - 0085
NOT_YET_RECRUITING
Blumenau
Local Institution - 0094
NOT_YET_RECRUITING
Campinas
Liga Norte Riograndense Contra o Câncer
RECRUITING
Natal
Local Institution - 0346
NOT_YET_RECRUITING
Porto Alegre
Local Institution - 0091
NOT_YET_RECRUITING
Rio De Janeiro
Local Institution - 0355
NOT_YET_RECRUITING
São Caetano Do Sul
Fundação Faculdade Regional de Medicina de São José do Rio Preto
RECRUITING
São José Do Rio Preto
A. C. Camargo Cancer Center
RECRUITING
São Paulo
Local Institution - 0078
NOT_YET_RECRUITING
São Paulo
CEDOES
RECRUITING
Vitória
Bulgaria
Specialized Hospital for Active Treatment of Oncology - Haskovo
RECRUITING
Haskovo
Local Institution - 0315
NOT_YET_RECRUITING
Panagyurishte
Complex Oncology Center - Ruse EOOD
RECRUITING
Rousse
Local Institution - 0459
NOT_YET_RECRUITING
Sofia
Local Institution - 0460
NOT_YET_RECRUITING
Sofia
Trakia Hospital
RECRUITING
Stara Zagora
China
Local Institution - 0049
NOT_YET_RECRUITING
Beijing
Local Institution - 0074
NOT_YET_RECRUITING
Beijing
Local Institution - 0286
NOT_YET_RECRUITING
Beijing
Local Institution - 0050
NOT_YET_RECRUITING
Changsha
Local Institution - 0387
NOT_YET_RECRUITING
Changsha
Sichuan Cancer hospital
RECRUITING
Chengdu
West China Hospital Sichuan University
RECRUITING
Chengdu
Local Institution - 0046
NOT_YET_RECRUITING
Fuzhou
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Local Institution - 0061
NOT_YET_RECRUITING
Guangzhou
The First Affiliated Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
Local Institution - 0408
NOT_YET_RECRUITING
Guiyang
Local Institution - 0069
NOT_YET_RECRUITING
Hangzhou
Local Institution - 0280
NOT_YET_RECRUITING
Hangzhou
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Local Institution - 0106
NOT_YET_RECRUITING
Harbin
Local Institution - 0072
NOT_YET_RECRUITING
Hefei
Local Institution - 0051
NOT_YET_RECRUITING
Jinan
LinYi Cancer Hospital
RECRUITING
Linyi
The First affiliated hospital of Nanchang University (Xianghu campus)
RECRUITING
Nanchang
Local Institution - 0279
NOT_YET_RECRUITING
Nanjing
Local Institution - 0352
NOT_YET_RECRUITING
Nanjing
Nanjing First Hospital
RECRUITING
Nanjing
Guangxi Medical University Affiliated Cancer Hospital
RECRUITING
Nanning
Local Institution - 0068
NOT_YET_RECRUITING
Qingdao
Local Institution - 0278
NOT_YET_RECRUITING
Shanghai
Zhongshan Hospital,Fudan University
RECRUITING
Shanghai
Liaoning Cancer Hospital
RECRUITING
Shenyang
Local Institution - 0104
NOT_YET_RECRUITING
Shenyang
Local Institution - 0284
NOT_YET_RECRUITING
Shenyang
Local Institution - 0281
NOT_YET_RECRUITING
Shenzhen
Local Institution - 0353
NOT_YET_RECRUITING
Shijiazhuang
Local Institution - 0283
NOT_YET_RECRUITING
Taiyuan
Hubei Cancer Hospital
RECRUITING
Wuhan
Wuhan Union Hospital Cancer Center
RECRUITING
Wuhan
Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army
RECRUITING
Xi'an
Local Institution - 0100
NOT_YET_RECRUITING
Xiamen
Local Institution - 0047
NOT_YET_RECRUITING
Zhengzhou
Local Institution - 0107
NOT_YET_RECRUITING
Zhengzhou
Colombia
Local Institution - 0305
NOT_YET_RECRUITING
Bogotá
Local Institution - 0330
NOT_YET_RECRUITING
Medellín
Local Institution - 0306
NOT_YET_RECRUITING
Montería
Denmark
Local Institution - 0356
NOT_YET_RECRUITING
Copenhagen
France
Chu Jean Minjoz
RECRUITING
Besançon
CHRU de Brest
RECRUITING
Brest
Hospices Civils de Lyon - Hopital Louis Pradel
RECRUITING
Bron
Centre François Baclesse
RECRUITING
Caen
Chu Gabriel Montpied
RECRUITING
Clermont-ferrand
Local Institution - 0213
NOT_YET_RECRUITING
Créteil
Local Institution - 0212
NOT_YET_RECRUITING
Dijon
Institut Paoli-Calmettes
RECRUITING
Marseille
Local Institution - 0220
NOT_YET_RECRUITING
Montpellier
Groupe hospitalier Paris saint Joseph
RECRUITING
Paris
Institut Curie
RECRUITING
Paris
CHU Bordeaux Haut-Leveque
RECRUITING
Pessac
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
RECRUITING
Rennes
Local Institution - 0215
NOT_YET_RECRUITING
Saint-herblain
CHU de Toulouse - Hopital Larrey
RECRUITING
Toulouse
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
RECRUITING
Tours
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
RECRUITING
Vandœuvre-lès-nancy
Germany
Local Institution - 0198
NOT_YET_RECRUITING
Berlin
Local Institution - 0551
NOT_YET_RECRUITING
Bonn
Local Institution - 0461
NOT_YET_RECRUITING
Göppingen
LungenClinic Grosshansdorf
RECRUITING
Großhansdorf
Lungenfachklinik Immenhausen
RECRUITING
Immenhausen
Klinik Löwenstein
RECRUITING
Löwenstein
Local Institution - 0202
NOT_YET_RECRUITING
München
Pius Hospital Oldenburg
RECRUITING
Oldenburg
Krankenhaus Barmherzige Brüder Regensburg
RECRUITING
Regensburg
Robert Bosch Krankenhaus GmbH
RECRUITING
Stuttgart
Bundeswehrkrankenhaus Ulm
RECRUITING
Ulm
Greece
Alexandra General Hospital of Athens
RECRUITING
Athens
Errikos Dunant Hospital Center
RECRUITING
Athens
Thoracic General Hospital of Athens I Sotiria
RECRUITING
Athens
University General Hospital of Larissa
RECRUITING
Larissa
University Hospital of Patras
RECRUITING
Pátrai
Local Institution - 0006
NOT_YET_RECRUITING
Thessaloniki
Hong Kong Special Administrative Region
Queen Mary Hospital
RECRUITING
Hksar
Local Institution - 0323
NOT_YET_RECRUITING
Shatin
Hungary
Local Institution - 0288
NOT_YET_RECRUITING
Budapest
Farkasgyepui Tudogyogyintezet
RECRUITING
Farkasgyepű
Local Institution - 0291
NOT_YET_RECRUITING
Gyöngyös
Local Institution - 0290
NOT_YET_RECRUITING
Gyula
India
Local Institution - 0263
NOT_YET_RECRUITING
Bangalore
Local Institution - 0344
NOT_YET_RECRUITING
Bengaluru
Local Institution - 0265
NOT_YET_RECRUITING
Hyderabad
Local Institution - 0266
NOT_YET_RECRUITING
Mumbai
Local Institution - 0345
NOT_YET_RECRUITING
Mumbai
Local Institution - 0267
NOT_YET_RECRUITING
New Delhi
Local Institution - 0264
NOT_YET_RECRUITING
Varanasi
Israel
Local Institution - 0016
NOT_YET_RECRUITING
Afula
Local Institution - 0014
NOT_YET_RECRUITING
Haifa
Local Institution - 0013
NOT_YET_RECRUITING
Jerusalem
Local Institution - 0017
WITHDRAWN
Jerusalem
Local Institution - 0010
NOT_YET_RECRUITING
Kfar Saba
Local Institution - 0011
NOT_YET_RECRUITING
Ramat Gan
Italy
Cro-Irccs
RECRUITING
Aviano
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
RECRUITING
Bologna
Local Institution - 0039
NOT_YET_RECRUITING
Milan
Ospedale San Raffaele
RECRUITING
Milan
AOU della Campania Luigi Vanvitelli
RECRUITING
Naples
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
RECRUITING
Orbassano
AO Santa Maria della Misericordia
RECRUITING
Perugia
Ospedale Santa Maria delle Croci
RECRUITING
Ravenna
Local Institution - 0468
NOT_YET_RECRUITING
Verona
Japan
Local Institution - 0234
NOT_YET_RECRUITING
Bunkyo-ku
Local Institution - 0246
NOT_YET_RECRUITING
Fukuoka
Local Institution - 0245
NOT_YET_RECRUITING
Hidaka
Local Institution - 0336
NOT_YET_RECRUITING
Himeji
Local Institution - 0240
NOT_YET_RECRUITING
Hirakata
Local Institution - 0236
NOT_YET_RECRUITING
Kashiwa
Local Institution - 0257
NOT_YET_RECRUITING
Kawasaki
Local Institution - 0247
NOT_YET_RECRUITING
Kobe
Local Institution - 0237
NOT_YET_RECRUITING
Matsusaka
Local Institution - 0243
NOT_YET_RECRUITING
Nagoya
Local Institution - 0241
NOT_YET_RECRUITING
Nankoku
Local Institution - 0244
NOT_YET_RECRUITING
Okayama
Local Institution - 0239
NOT_YET_RECRUITING
Osaka
Local Institution - 0334
NOT_YET_RECRUITING
Otashi
Local Institution - 0233
NOT_YET_RECRUITING
Sapporo
Local Institution - 0232
NOT_YET_RECRUITING
Sendai
Local Institution - 0235
NOT_YET_RECRUITING
Shimotsuga
Local Institution - 0335
NOT_YET_RECRUITING
Shiwa-gun Yahaba-cho
Local Institution - 0242
NOT_YET_RECRUITING
Ube
Local Institution - 0238
NOT_YET_RECRUITING
Yokohama
Malaysia
Local Institution - 0413
NOT_YET_RECRUITING
Kuala Lumpur
Local Institution - 0390
NOT_YET_RECRUITING
Kuching
Mexico
Local Institution - 0327
NOT_YET_RECRUITING
Chihuahua City
Local Institution - 0296
NOT_YET_RECRUITING
Guadalajara
Local Institution - 0326
NOT_YET_RECRUITING
Guadalajara
Local Institution - 0293
NOT_YET_RECRUITING
Mexico City
Local Institution - 0294
WITHDRAWN
Mexico City
Local Institution - 0298
NOT_YET_RECRUITING
Monterrey
Local Institution - 0297
NOT_YET_RECRUITING
Oaxaca City
Local Institution - 0331
NOT_YET_RECRUITING
Puebla City
Local Institution - 0328
NOT_YET_RECRUITING
Querétaro
Netherlands
Local Institution - 0230
WITHDRAWN
Arnhem
University Medical Center Groningen
RECRUITING
Groningen
Local Institution - 0445
NOT_YET_RECRUITING
Veldhoven
Norway
Local Institution - 0096
NOT_YET_RECRUITING
Drammen
Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka
RECRUITING
Bydgoszcz
Local Institution - 0259
WITHDRAWN
Krakow
Centrum Medyczne Pratia Poznań
RECRUITING
Poznan
Szpital Specjalistyczny w Prabutach Spolka z o.o.
RECRUITING
Prabuty
Local Institution - 0261
WITHDRAWN
Warsaw
Local Institution - 0458
NOT_YET_RECRUITING
Wieliszew
Republic of Korea
Local Institution - 0272
NOT_YET_RECRUITING
Cheongju-si
National Cancer Center
RECRUITING
Goyang-si
Seoul National University Bundang Hospital
RECRUITING
Seongnam
Asan Medical Center
RECRUITING
Seoul
Local Institution - 0270
NOT_YET_RECRUITING
Seoul
Local Institution - 0471
NOT_YET_RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Romania
Centrul de Diagnostic si Tratament Provita
RECRUITING
Bucharest
Institutul Oncologic Bucuresti Prof. Dr. Alexandru Trestioreanu
RECRUITING
Bucharest
Institutul Oncologic Cluj
RECRUITING
Cluj-napoca
Institutul Oncologic Cluj
RECRUITING
Cluj-napoca
Centrul de Oncologie Sfântul Nectarie
RECRUITING
Craiova
SC Radiotherapy Center Cluj SRL
RECRUITING
Florești
Institutul Regional de Oncologie
RECRUITING
Iași
S.C. Centrul de Oncologie Euroclinic S.R.L.
RECRUITING
Iași
Radiology Therapeutic Center
RECRUITING
Otopeni
Spitalul Municipal Schuller Ploiești
RECRUITING
Ploieşti
Spain
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Local Institution - 0253
WITHDRAWN
Barcelona
Local Institution - 0248
NOT_YET_RECRUITING
Hospitalet
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Local Institution - 0118
NOT_YET_RECRUITING
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
RECRUITING
Majadahonda
H.R.U Málaga - Hospital General
RECRUITING
Málaga
Hospital Universitario Virgen Del Rocio
RECRUITING
Seville
Local Institution - 0255
NOT_YET_RECRUITING
Valencia
Sweden
Sahlgrenska Universitetssjukhuset
RECRUITING
Gothenburg
Taiwan
Chi Mei Hospital - Liouying Branch
RECRUITING
Tainan
National Cheng Kung University Hospital
RECRUITING
Tainan
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Medical University Hospital
RECRUITING
Taipei
Chang Gung Medical Foundation-Linkou Branch
RECRUITING
Taoyuan District
Thailand
Local Institution - 0411
NOT_YET_RECRUITING
Bangkok
Local Institution - 0412
NOT_YET_RECRUITING
Bangkok
Turkey
Local Institution - 0317
NOT_YET_RECRUITING
Adana
Local Institution - 0318
NOT_YET_RECRUITING
Adana
Local Institution - 0321
NOT_YET_RECRUITING
Ankara
Local Institution - 0350
NOT_YET_RECRUITING
Antalya
Local Institution - 0320
NOT_YET_RECRUITING
Bursa
Local Institution - 0319
NOT_YET_RECRUITING
Edirne
Local Institution - 0349
NOT_YET_RECRUITING
Izmir, Karsiyaka
United Kingdom
Leicester Royal Infirmary
RECRUITING
Leicester
Sarah Cannon Research Institute UK
RECRUITING
London
Contact Information
Primary
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain NCT # and Site #.
Time Frame
Start Date: 2026-01-02
Estimated Completion Date: 2031-08-12
Participants
Target number of participants: 590
Treatments
Active_comparator: Arm A: BMS-986504 + Pembrolizumab + Chemotherapy
Active_comparator: Arm B: BMS-986504 + Pembrolizumab + Chemotherapy
Placebo_comparator: Arm C: Placebo + Pembrolizumab + Chemotherapy
Placebo_comparator: Arm D: Placebo + Pembrolizumab + Chemotherapy
Active_comparator: Arm E: BMS-986504 + Pembrolizumab + Chemotherapy
Placebo_comparator: Arm F: Placebo + Pembrolizumab + Chemotherapy
Related Therapeutic Areas
Sponsors
Leads: Bristol-Myers Squibb