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 (239) 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
Local Institution - 0388
NOT_YET_RECRUITING
Phoenix
Local Institution - 0120
NOT_YET_RECRUITING
Tucson
California
Local Institution - 0407
NOT_YET_RECRUITING
Los Angeles
Florida
Local Institution - 0152
NOT_YET_RECRUITING
Fort Lauderdale
Local Institution - 0389
NOT_YET_RECRUITING
Jacksonville
Local Institution - 0430
WITHDRAWN
St. Petersburg
Idaho
Local Institution - 0124
NOT_YET_RECRUITING
Boise
Kentucky
Local Institution - 0125
NOT_YET_RECRUITING
Lexington
Local Institution - 0333
NOT_YET_RECRUITING
Lexington
Massachusetts
Local Institution - 0158
NOT_YET_RECRUITING
Boston
Maine
Local Institution - 0127
NOT_YET_RECRUITING
Scarborough
Michigan
Local Institution - 0405
NOT_YET_RECRUITING
Detroit
Local Institution - 0420
NOT_YET_RECRUITING
Traverse City
Minnesota
Local Institution - 0182
NOT_YET_RECRUITING
Rochester
Nebraska
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
RECRUITING
Omaha
New York
Local Institution - 0179
NOT_YET_RECRUITING
Hawthorne
Local Institution - 0128
NOT_YET_RECRUITING
Rochester
Ohio
Local Institution - 0163
NOT_YET_RECRUITING
Cleveland
Local Institution - 0129
NOT_YET_RECRUITING
Columbus
Oregon
Local Institution - 0164
NOT_YET_RECRUITING
Portland
Local Institution - 0348
NOT_YET_RECRUITING
Portland
Texas
Local Institution - 0433
NOT_YET_RECRUITING
Dallas
Local Institution - 0374
NOT_YET_RECRUITING
El Paso
Local Institution - 0132
NOT_YET_RECRUITING
Houston
Local Institution - 0377
NOT_YET_RECRUITING
The Woodlands
Utah
Local Institution - 0354
NOT_YET_RECRUITING
Salt Lake City
Virginia
Local Institution - 0131
WITHDRAWN
Fairfax
Local Institution - 0186
NOT_YET_RECRUITING
Richmond
Washington
Local Institution - 0145
NOT_YET_RECRUITING
Seattle
Other Locations
Argentina
Local Institution - 0446
NOT_YET_RECRUITING
Buenos Aires
Local Institution - 0447
NOT_YET_RECRUITING
Buenos Aires
Australia
Local Institution - 0367
NOT_YET_RECRUITING
Ballarat Central
Local Institution - 0382
NOT_YET_RECRUITING
Birtinya
Local Institution - 0381
NOT_YET_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
Local Institution - 0207
NOT_YET_RECRUITING
Vienna
Belgium
Local Institution - 0342
NOT_YET_RECRUITING
Brussels
Local Institution - 0227
NOT_YET_RECRUITING
Edegem
Local Institution - 0226
NOT_YET_RECRUITING
Hasselt
Local Institution - 0340
NOT_YET_RECRUITING
Liège
Local Institution - 0277
NOT_YET_RECRUITING
Roeselare
Local Institution - 0225
NOT_YET_RECRUITING
Yvoir
Brazil
Local Institution - 0081
NOT_YET_RECRUITING
Barretos
Local Institution - 0076
NOT_YET_RECRUITING
Bauru
Local Institution - 0085
NOT_YET_RECRUITING
Blumenau
Local Institution - 0094
NOT_YET_RECRUITING
Campinas
Local Institution - 0079
NOT_YET_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
Local Institution - 0351
NOT_YET_RECRUITING
São José Do Rio Preto
Local Institution - 0078
NOT_YET_RECRUITING
São Paulo
Local Institution - 0095
NOT_YET_RECRUITING
São Paulo
Local Institution - 0088
NOT_YET_RECRUITING
Vitória
Bulgaria
Local Institution - 0309
NOT_YET_RECRUITING
Haskovo
Local Institution - 0315
NOT_YET_RECRUITING
Panagyurishte
Local Institution - 0308
NOT_YET_RECRUITING
Rousse
Local Institution - 0307
NOT_YET_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
Local Institution - 0102
NOT_YET_RECRUITING
Chengdu
Local Institution - 0109
NOT_YET_RECRUITING
Chengdu
Local Institution - 0046
NOT_YET_RECRUITING
Fuzhou
Local Institution - 0061
NOT_YET_RECRUITING
Guangzhou
Local Institution - 0099
NOT_YET_RECRUITING
Guangzhou
Local Institution - 0443
NOT_YET_RECRUITING
Guangzhou
Local Institution - 0408
NOT_YET_RECRUITING
Guiyang
Local Institution - 0054
NOT_YET_RECRUITING
Hangzhou
Local Institution - 0069
NOT_YET_RECRUITING
Hangzhou
Local Institution - 0280
NOT_YET_RECRUITING
Hangzhou
Local Institution - 0106
NOT_YET_RECRUITING
Harbin
Local Institution - 0072
NOT_YET_RECRUITING
Hefei
Local Institution - 0051
NOT_YET_RECRUITING
Jinan
Local Institution - 0066
NOT_YET_RECRUITING
Linyi
Local Institution - 0110
NOT_YET_RECRUITING
Nanchang
Local Institution - 0279
NOT_YET_RECRUITING
Nanjing
Local Institution - 0352
NOT_YET_RECRUITING
Nanjing
Local Institution - 0386
NOT_YET_RECRUITING
Nanjing
Local Institution - 0067
NOT_YET_RECRUITING
Nanning
Local Institution - 0068
NOT_YET_RECRUITING
Qingdao
Local Institution - 0278
NOT_YET_RECRUITING
Shanghai
Local Institution - 0343
NOT_YET_RECRUITING
Shanghai
Local Institution - 0103
NOT_YET_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
Local Institution - 0048
NOT_YET_RECRUITING
Wuhan
Local Institution - 0059
NOT_YET_RECRUITING
Wuhan
Local Institution - 0060
NOT_YET_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
Local Institution - 0341
NOT_YET_RECRUITING
Besançon
Local Institution - 0221
NOT_YET_RECRUITING
Brest
Local Institution - 0217
NOT_YET_RECRUITING
Caen
Local Institution - 0223
NOT_YET_RECRUITING
Clermont-ferrand
Local Institution - 0213
NOT_YET_RECRUITING
Créteil
Local Institution - 0212
NOT_YET_RECRUITING
Dijon
Local Institution - 0224
NOT_YET_RECRUITING
Marseille
Local Institution - 0220
NOT_YET_RECRUITING
Montpellier
Local Institution - 0218
NOT_YET_RECRUITING
Paris
Local Institution - 0429
NOT_YET_RECRUITING
Paris
Local Institution - 0219
NOT_YET_RECRUITING
Pessac
Local Institution - 0214
NOT_YET_RECRUITING
Pierre-bénite
Local Institution - 0222
NOT_YET_RECRUITING
Rennes
Local Institution - 0215
NOT_YET_RECRUITING
Saint-herblain
Local Institution - 0216
NOT_YET_RECRUITING
Toulouse
Local Institution - 0338
NOT_YET_RECRUITING
Tours
Local Institution - 0211
NOT_YET_RECRUITING
Vandœuvre-lès-nancy
Germany
Local Institution - 0202
NOT_YET_RECRUITING
München
Local Institution - 0209
NOT_YET_RECRUITING
Regensburg
Greece
Local Institution - 0001
NOT_YET_RECRUITING
Athens
Local Institution - 0005
NOT_YET_RECRUITING
Athens
Local Institution - 0009
NOT_YET_RECRUITING
Athens
Local Institution - 0003
NOT_YET_RECRUITING
Larissa
Local Institution - 0008
NOT_YET_RECRUITING
Pátrai
Local Institution - 0006
NOT_YET_RECRUITING
Thessaloniki
Hong Kong Special Administrative Region
Local Institution - 0285
NOT_YET_RECRUITING
Hksar
Local Institution - 0323
NOT_YET_RECRUITING
Shatin
Hungary
Local Institution - 0288
NOT_YET_RECRUITING
Budapest
Local Institution - 0287
NOT_YET_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
NOT_YET_RECRUITING
Jerusalem
Local Institution - 0010
NOT_YET_RECRUITING
Kfar Saba
Local Institution - 0011
NOT_YET_RECRUITING
Ramat Gan
Italy
Local Institution - 0042
NOT_YET_RECRUITING
Aviano
Local Institution - 0098
NOT_YET_RECRUITING
Bologna
Local Institution - 0039
NOT_YET_RECRUITING
Milan
Local Institution - 0045
NOT_YET_RECRUITING
Milan
Local Institution - 0105
NOT_YET_RECRUITING
Napoli
Local Institution - 0037
NOT_YET_RECRUITING
Orbassano
Local Institution - 0044
NOT_YET_RECRUITING
Perugia
Local Institution - 0035
NOT_YET_RECRUITING
Ravenna
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 City
Netherlands
Local Institution - 0230
WITHDRAWN
Arnhem
Local Institution - 0249
NOT_YET_RECRUITING
Groningen
Local Institution - 0445
NOT_YET_RECRUITING
Veldhoven
Norway
Local Institution - 0096
NOT_YET_RECRUITING
Drammen
Poland
Local Institution - 0260
NOT_YET_RECRUITING
Bydgoszcz
Local Institution - 0259
NOT_YET_RECRUITING
Krakow
Local Institution - 0262
NOT_YET_RECRUITING
Poznan
Local Institution - 0258
NOT_YET_RECRUITING
Prabuty
Local Institution - 0261
NOT_YET_RECRUITING
Warsaw
Republic of Korea
Local Institution - 0272
NOT_YET_RECRUITING
Cheongju-si
Local Institution - 0271
NOT_YET_RECRUITING
Goyang-si
Local Institution - 0273
NOT_YET_RECRUITING
Seongnam
Local Institution - 0268
NOT_YET_RECRUITING
Seoul
Local Institution - 0269
NOT_YET_RECRUITING
Seoul
Local Institution - 0270
NOT_YET_RECRUITING
Seoul
Local Institution - 0274
NOT_YET_RECRUITING
Seoul
Romania
Local Institution - 0020
NOT_YET_RECRUITING
Bucharest
Local Institution - 0021
NOT_YET_RECRUITING
Bucharest
Local Institution - 0022
NOT_YET_RECRUITING
Cluj-napoca
Local Institution - 0023
NOT_YET_RECRUITING
Cluj-napoca
Local Institution - 0025
NOT_YET_RECRUITING
Craiova
Local Institution - 0019
NOT_YET_RECRUITING
Florești
Local Institution - 0026
NOT_YET_RECRUITING
Iași
Local Institution - 0031
NOT_YET_RECRUITING
Iași
Local Institution - 0027
NOT_YET_RECRUITING
Otopeni
Local Institution - 0030
NOT_YET_RECRUITING
Ploieşti
Spain
Local Institution - 0116
NOT_YET_RECRUITING
Barcelona
Local Institution - 0253
WITHDRAWN
Barcelona
Local Institution - 0248
NOT_YET_RECRUITING
Hospitalet
Local Institution - 0118
NOT_YET_RECRUITING
Madrid
Local Institution - 0254
NOT_YET_RECRUITING
Madrid
Local Institution - 0252
NOT_YET_RECRUITING
Majadahonda
Local Institution - 0117
NOT_YET_RECRUITING
Málaga
Local Institution - 0256
NOT_YET_RECRUITING
Seville
Local Institution - 0255
NOT_YET_RECRUITING
Valencia
Taiwan
Local Institution - 0111
NOT_YET_RECRUITING
Tainan City
Local Institution - 0114
NOT_YET_RECRUITING
Tainan City
Local Institution - 0113
NOT_YET_RECRUITING
Taipei
Taipei Medical University Hospital
RECRUITING
Taipei
Local Institution - 0112
NOT_YET_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
Local Institution - 0228
NOT_YET_RECRUITING
London
Contact Information
Primary
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Clinical.Trials@bms.com
8559073286
Backup
First line of the email MUST contain the NCT# and Site#
Time Frame
Start Date: 2025-10-06
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