Metastatic Non-small Cell Lung Cancer With MTAP DeletionPhase 2/3MountainTAP-29NCT07063745
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 Phase 2/3 study testing BMS-986504, Pembrolizumab and Cisplatin in people with Metastatic Non-small Cell Lung Cancer With MTAP Deletion, run by Bristol-Myers Squibb at 321 sites in 34 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Non-small Cell Lung Cancer With MTAP Deletion
- What is being tested?
- BMS-986504, Pembrolizumab and Cisplatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 590 participants
- Where
- 321 sitesin 34 countries
- Study dates
- 2 Jan 2026to 12 Aug 2031
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
321 sites in 34 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
321 sites in 34 countries
United States44 sites, 34 recruiting
- Completed
Local Institution - 0119
Anchorage, Alaska, 99508
- Not yet recruiting
Local Institution - 0418
Ann Arbor, Michigan, 48109
Site 0418
- Recruiting
St. Luke's Cancer Institute: Boise
Boise, Idaho, 83712
Sri Harsha Tella, Site 0124
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Pasi Janne, Site 0158, 617-632-6036
- Withdrawn
Local Institution - 0163
Cleveland, Ohio, 44195
- Recruiting
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Timothy Burns, Site 0129, 412-864-7859
- Recruiting
UT Southwestern Medical Center Simmons Comprehensive Cancer Center
Dallas, Texas, 75235
Arthi Sridhar, Site 0433, 908-251-1303
- Recruiting
Cancer Care Specialists of Illinois - Cancer Care Center of O'Fallon
Decatur, Illinois, 62526
James Wade, Site 0605, 217-876-6611
- Not yet recruiting
Local Institution - 0405
Detroit, Michigan, 48201
Site 0405
- Completed
Local Institution - 0374
El Paso, Texas, 79915
- Withdrawn
Local Institution - 0131
Fairfax, Virginia, 22031
- Recruiting
Helios Clinical Research - Fort Lauderdale
Fort Lauderdale, Florida, 33316
Edgardo Santos, Site 0152, 239-938-9315
- Not yet recruiting
Local Institution - 0608
Greenville, South Carolina, 29607
Site 0608
- Recruiting
WMCHealth Advanced Physician Services
Hawthorne, New York, 10532
Marjorie Zauderer, Site 0179, 914-493-8375
- Withdrawn
Local Institution - 0559
Hershey, Pennsylvania, 17033
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Natalie Vokes, Site 0132, 000-000-0000
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Shenduo Li, Site 0389, 904-953-0315
- Withdrawn
Local Institution - 0515
Knoxville, Tennessee, 37920
- Not yet recruiting
Local Institution - 0467
Lebanon, New Hampshire, 03756
Site 0467
- Recruiting
Baptist Health Lexington
Lexington, Kentucky, 40503
Firas Badin, Site 0333, 859-260-6100
- Recruiting
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536
John Villano, Site 0125, 859-323-6522
- Not yet recruiting
Local Institution - 0497
Los Alamitos, California, 90720
Site 0497
- Recruiting
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Robert Hsu, Site 0407, 323-865-3000
- Withdrawn
Local Institution - 0444
Los Angeles, California, 90067
- Not yet recruiting
Local Institution - 0600
Manchester, New Hampshire, 03103
Site 0600
- Withdrawn
Local Institution - 0606
Newark, Delaware, 19713
- Recruiting
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska, 68130
Geetha Palaniappan, Site 0160, 402-593-3141
- Recruiting
Mayo Clinic in Arizona - Phoenix
Phoenix, Arizona, 85054
Antonious Hazim, Site 0388
- Recruiting
Providence Portland Medical Center
Portland, Oregon, 97213
Rachel Sanborn, Site 0164, 503-215-5696
- Recruiting
Kaiser Permanente Interstate Medical Office Central
Portland, Oregon, 97227
Sandeep Mashru, Site 0348, 503-249-3315
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23219
Renato Martins, Site 0186, 804-828-7999
- Recruiting
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, 55905
Konstantinos Leventakos, Site 0182, 507-284-2511
- Not yet recruiting
Local Institution - 0128
Rochester, New York, 14642
Site 0128
- Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Matthew Gumbleton, Site 0354, 801-587-4557
- Not yet recruiting
Local Institution - 0127
Scarborough, Maine, 04074
Site 0127
- Not yet recruiting
Local Institution - 0518
Schenectady, New York, 12308
Site 0518
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Lei Deng, Site 0145, 206-606-4801
- Recruiting
Highlands Oncology Group
Springdale, Arkansas, 72762
Eric Schaefer, Site 0135, 479-872-8130
- Withdrawn
Local Institution - 0430
St. Petersburg, Florida, 33709
- Not yet recruiting
Local Institution - 0523
Tampa, Florida, 33612
Site 0523
- Withdrawn
Local Institution - 0377
The Woodlands, Texas, 77380
- Not yet recruiting
Local Institution - 0420
Traverse City, Michigan, 49684
Site 0420
- Recruiting
University of Arizona Cancer Center
Tucson, Arizona, 85724
Ricklie Julian, Site 0120, 850-557-2723
- Not yet recruiting
Local Institution - 0514
Winston-Salem, North Carolina, 27157
Site 0514
China43 sites, 42 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100034
Fan Yang, Site 0074, +8613651078631
- Not yet recruiting
Local Institution - 0049
Beijing, Beijing Municipality, 100142
Site 0049
- Not yet recruiting
Local Institution - 0286
Beijing, Beijing Municipality, 100142
Site 0286
- Not yet recruiting
Local Institution - 0621
Beijing, Beijing Municipality, 101149
Site 0621
- Not yet recruiting
Local Institution - 0075
Changchun, Jilin, 132000
Site 0075
- Not yet recruiting
Local Institution - 0057
Changsha, Hunan, 0
Site 0057
- Not yet recruiting
Local Institution - 0387
Changsha, Hunan, 410008
Site 0387
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Lin Wu, Site 0050, 8613170419973
- Recruiting
Sichuan Cancer hospital
Chengdu, Sichuan, 610041
Wenxiu Yao, Site 0102, 18908178836
- Recruiting
West China Hospital Sichuan University
Chengdu, Sichuan, 611135
Yalun Li, Site 0109, 18628250623
- Not yet recruiting
Local Institution - 0108
Chongqing, Chongqing Municipality, 400030
Site 0108
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Yunjian Huang, Site 0046
- Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 0
Kejing Tang, Site 0099, 8613802946566
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510000
Huibing Gao, Site 0443
- Not yet recruiting
Local Institution - 0061
Guangzhou, Guangdong, 510515
Site 0061
- Not yet recruiting
Local Institution - 0408
Guiyang, Guizhou, 550002
Site 0408
- Recruiting
The first Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Jianying Zhou, Site 0280, 8613505719970
- Not yet recruiting
Local Institution - 0069
Hangzhou, Zhejiang, 310016
Site 0069
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Xinmin Yu, Site 0054, 8613705718617
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Yan Yu, Site 0106, 13904505825
- Not yet recruiting
Local Institution - 0072
Hefei, Anhui, 230031
Site 0072
- Not yet recruiting
Local Institution - 0051
Jinan, Shandong, 250117
Site 0051
- Recruiting
LinYi Cancer Hospital
Linyi, Shandong, 276001
Jianhua Shi, Site 0066, +8615963998868
- Recruiting
The First affiliated hospital of Nanchang University (Xianghu campus)
Nanchang, Jiangxi, 330209
Longhua Sun, Site 0110, 8613698091288
- Not yet recruiting
Local Institution - 0352
Nanjing, Jiangsu, 210000
Site 0352
- Not yet recruiting
Local Institution - 0279
Nanjing, Jiangsu, 210009
Site 0279
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210012
Surong Fang, Site 0386, 13382080588
- Recruiting
Guangxi Medical University Affiliated Cancer Hospital
Nanning, Guangxi, 530021
Shaozhang Zhou, Site 0067, 8613977183708
- Not yet recruiting
Local Institution - 0068
Qingdao, Shandong, 266003
Site 0068
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Hua Zhong, Site 0278, 13818200560
- Recruiting
Zhongshan Hospital,Fudan University
Shanghai, Shanghai Municipality, 200032
Yong Zhang, Site 0343, 15000229853
- Not yet recruiting
Local Institution - 0284
Shenyang, Liaoning, 110001
Site 0284
- Not yet recruiting
Local Institution - 0104
Shenyang, Liaoning, 110004
Site 0104
- Recruiting
Liaoning Cancer Hospital
Shenyang, Liaoning, 110042
Hongxu Liu, Site 0103, 8618040097698
- Not yet recruiting
Local Institution - 0281
Shenzhen, Guangdong, 518020
Site 0281
- Not yet recruiting
Local Institution - 0353
Shijiazhuang, Hebei, 050035
Site 0353
- Not yet recruiting
Local Institution - 0283
Taiyuan, Shanxi, 030000
Site 0283
- Recruiting
Wuhan Union Hospital Cancer Center
Wuhan, Hubei, 430023
Rui Meng, Site 0048, 008613995612493
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Bin Yang, Site 0059, 8613407192282
- Completed
Local Institution - 0060
Xi'an, Shaanxi, 710038
- Recruiting
The First Affiliated hospital of Xiamen University
Xiamen, Fujian, 361003
Feng Ye, Site 0100, 8613860458889
- Not yet recruiting
Local Institution - 0107
Zhengzhou, Henan, 450000
Site 0107
- Not yet recruiting
Local Institution - 0047
Zhengzhou, Henan, 450008
Site 0047
France20 sites, 20 recruiting
- Recruiting
Chu Jean Minjoz
Besançon, Doubs, 25000
Virginie Westeel, Site 0341, 33370632440
- Recruiting
CHRU de Brest
Brest, Finistère, 29200
Gilles Quere, Site 0221, 33298223578
- Recruiting
Hospices Civils de Lyon - Hopital Louis Pradel
Bron, Rhône, 69677
Michael Duruisseaux, Site 0214, 33427857700
- Recruiting
Centre François Baclesse
Caen, Calvados, 14076
Hubert CURCIO, Site 0217, 0231455050
- Recruiting
Chu Gabriel Montpied
Clermont-Ferrand, Puy-de-Dôme, 63000
Patrick MERLE, Site 0223, 0473751649
- Recruiting
Centre Hospitalier Intercommunal de Créteil
Créteil, Val-de-Marne, 94010
Jean-Baptiste Assié, Site 0213, 0157022101
- Recruiting
Centre Georges François Leclerc
Dijon, Côte-d'Or, 21079
Coureche Kaderbhai, Site 0212, 33380737504
- Recruiting
Institut Paoli-Calmettes
Marseille, Provence-Alpes-Côte d'Azur Region, 13273
Anne Madroszyk, Site 0224, 33491223789
- Not yet recruiting
Local Institution - 0220
Montpellier, Hérault, 34298
Site 0220
- Recruiting
Centre Hospitalier Universitaire de Nice - Hopital Pasteur
Nice, Alpes-Maritimes, 06000
Jonathan Benzaquen, Site 0583
- Recruiting
Institut Curie
Paris, 75248
nicolas girard, Site 0218, +33624456290
- Recruiting
Groupe hospitalier Paris saint Joseph
Paris, Île-de-France Region, 75014
Carole Helissey, Site 0429, +33144128524
- Recruiting
CHU Bordeaux Haut-Leveque
Pessac, Aquitaine, 33600
Remi Veillon, Site 0219, 33557656338
- Recruiting
Institut Jean Godinot
Reims, 51726
Benoit Godbert, Site 0586
- Recruiting
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
Rennes, Ille-et-Vilaine, 35033
Charles Ricordel, Site 0222, +33299282481
- Not yet recruiting
Local Institution - 0215
Saint-Herblain, Loire-Atlantique, 44800
Site 0215
- Recruiting
CHU de Toulouse - Hopital Larrey
Toulouse, Haute-Garonne, 31059
Julien Mazieres, Site 0216, 33567771837
- Recruiting
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
Tours, 37032
Eric Pichon, Site 0338, 33247473787
- Recruiting
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511
Bertrand Mennecier, Site 0211, 33383154653
- Not yet recruiting
Local Institution - 0599
Villejuif, Val-De-Marne, 94805
Site 0599
Japan20 sites, 20 recruiting
- Not yet recruiting
Local Institution - 0234
Bunkyo-ku, Tokyo, 1138603
Site 0234
- Recruiting
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
Masafumi Yamaguchi, Site 0246, 81925413231
- Not yet recruiting
Local Institution - 0245
Hidaka, Saitama, 350-1298
Site 0245
- Not yet recruiting
Local Institution - 0336
Himeji, Hyōgo, 670-8520
Site 0336
- Not yet recruiting
Local Institution - 0240
Hirakata, Osaka, 573-1191
Site 0240
- Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
Hibiki Udagawa, Site 0236, 81471331111
- Recruiting
St. Marianna University Hospital
Kawasaki, Kanagawa, 216-8511
Naoki Furuya, Site 0257, 555-555-5555
- Not yet recruiting
Local Institution - 0247
Kobe, Hyōgo, 650-0047
Site 0247
- Not yet recruiting
Local Institution - 0237
Matsusaka, Mie-ken, 515-8544
Site 0237
- Not yet recruiting
Local Institution - 0243
Nagoya, Aichi-ken, 460-0001
Site 0243
- Not yet recruiting
Local Institution - 0241
Nankoku, Kochi, 783-8505
Site 0241
- Recruiting
National Hospital Organization Okayama Medical Center
Okayama, 701-1192
Keiichi Fujiwara, Site 0244, +81-86-294-9911
- Recruiting
Osaka City General Hospital
Osaka, 534-0021
Ayako Tanaka, Site 0239, +81669291221
- Not yet recruiting
Local Institution - 0334
Otashi, Gunma, 373-8550
Site 0334
- Recruiting
Hokkaido University Hospital
Sapporo, Hokkaido, 0608648
Jun Sakakibara, Site 0233, +81-11-716-1161
- Not yet recruiting
Local Institution - 0232
Sendai, Miyagi, 9810914
Site 0232
- Not yet recruiting
Local Institution - 0235
Shimotsuga, Tochigi, 321-0293
Site 0235
- Not yet recruiting
Local Institution - 0335
Shiwa-gun Yahaba-cho, Iwate, 028-3695
Site 0335
- Not yet recruiting
Local Institution - 0242
Ube, Yamaguchi, 755-0241
Site 0242
- Not yet recruiting
Local Institution - 0238
Yokohama, Kanagawa, 2418515
Site 0238
Germany16 sites, 15 recruiting
- Withdrawn
Local Institution - 0198
Berlin, 14165
- Not yet recruiting
Local Institution - 0551
Bonn, North Rhine-Westphalia, 53127
Site 0551
- Not yet recruiting
Local Institution - 0617
Donauwörth, Bavaria, 86609
Site 0617
- Not yet recruiting
Local Institution - 0626
Essen, North Rhine-Westphalia, 45147
Site 0626
- Recruiting
Alb Fils Kliniken GmbH
Göppingen, Baden-Wurttemberg, 73035
Martin Bommer, Site 0461
- Recruiting
LungenClinic Grosshansdorf
Großhansdorf, 22927
Martin Reck, Site 0197, 041026012101
- Not yet recruiting
Local Institution - 0582
Hemer, North Rhine-Westphalia, 58675
Site 0582
- Recruiting
Lungenfachklinik Immenhausen
Immenhausen, 34376
Achim Rittmeyer, Site 0204, 4956735011573
- Recruiting
Klinik Löwenstein
Löwenstein, 74245
Jonas Kuon, Site 0199, 4962213968008
- Recruiting
TUM Klinikum
München, Bavaria, 81675
Folker Schneller, Site 0202, +498941400
- Recruiting
Pius Hospital Oldenburg
Oldenburg, Lower Saxony, 26121
Frank Griesinger, Site 0201, 494412291611
- Recruiting
Krankenhaus Barmherzige Brüder Regensburg
Regensburg, Bavaria, 93049
Bernhard Braun, Site 0209, 094136994236
- Recruiting
Robert Bosch Krankenhaus GmbH
Stuttgart, Baden-Wurttemberg, 70376
Martin Kimmich, Site 0200, 4971181017719
- Not yet recruiting
Local Institution - 0623
Traunstein, Bavaria, 83278
Site 0623
- Not yet recruiting
Local Institution - 0580
Tübingen, Baden-Wurttemberg, 72076
Site 0580
- Recruiting
Bundeswehrkrankenhaus Ulm
Ulm, Baden-Wurttemberg, 89081
Matthias Mueller, Site 0462, +490731171031253
Brazil15 sites, 15 recruiting
- Recruiting
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, 14784400
Gustavo Dix Junqueira Pinto, Site 0081, 551733216637
- Recruiting
NAIC - Instituto do Câncer
Bauru, São Paulo, 17033-490
Marcelo Antunes, Site 0076, +5514997923873
- Recruiting
Clínica de Oncologia Reichow
Blumenau, Santa Catarina, 89010-340
Sandro Reichow, Site 0085, 5547996670458
- Recruiting
Centro de Pesquisa Sao Lucas
Campinas, São Paulo, 13060-803
Rafael Carmo, Site 0094, +5519992182311
- Recruiting
Pronutrir
Fortaleza, Ceará, 60810180
Herbert Tavares Palmeira, Site 0077, 558532865934
- Recruiting
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, 59062-000
Wendel Costa, Site 0079, 558440095595
- Recruiting
Unimed Porto Alegre
Porto Alegre, Rio Grande Do Sil, 90560003
Aline Wagner, Site 0576, +55 51 99336-9652
- Recruiting
Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul, 91350-200
Juliana de Menezes, Site 0346, 5551991922412
- Recruiting
Instituto Nacional de Câncer - INCA
Rio de Janeiro, 20231-050
Victor Santos, Site 0091, +552132076564
- Recruiting
Instituto de Oncologia Saint Gallen
Santa Cruz do Sul, Rio Grande do Sul, 96830-180
Bianca Correa Tabajara Weiss, Site 0080, 5551991898942
- Recruiting
Centro de Oncologia - CEON+ - Unidade São Caetano do Sul
São Caetano do Sul, São Paulo, 09541-270
Claudia Vaz de Melo Sette, Site 0355, 551149935491
- Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, 15090000
JOÃO SOLER, Site 0351, 551732015054
- Recruiting
A. C. Camargo Cancer Center
São Paulo, São Paulo, 01509-010
Thiago Oliveira, Site 0095, +5511993607754
- Recruiting
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, 01246-000
Marcelo Felizola, Site 0078, +551138932615
- Recruiting
CEDOES
Vitória, Espírito Santo, 29055450
Mauricio Pereira, Site 0088, +5521998795727
Mexico13 sites, 12 recruiting
- Not yet recruiting
Local Institution - 0327
Chihuahua City, 31203
Site 0327
- Recruiting
Cancer Treamtent Clinic and Clinical Trials Sa de Cv
Guadalajara, Jalisco, 44260
Juan Vazquez Limon, Site 0296, 523316063096
- Not yet recruiting
Local Institution - 0326
Guadalajara, Jalisco, 44680
Site 0326
- Withdrawn
Local Institution - 0294
Mexico City, Mexico City, 06760
- Not yet recruiting
Local Institution - 0609
Mexico City, Mexico City, 4700
Site 0609
- Recruiting
CENEIT Oncologicos
Mexico City, 03100
Alberto Suarez Zaizar, Site 0293, 525555342400
- Not yet recruiting
Local Institution - 0298
Monterrey, Nuevo León, 66460
Site 0298
- Not yet recruiting
Local Institution - 0297
Oaxaca City, Oaxaca, 68020
Site 0297
- Not yet recruiting
Local Institution - 0628
Puebla City, 72424
Site 0628
- Not yet recruiting
Local Institution - 0331
Puebla City, 72530
Site 0331
- Not yet recruiting
Local Institution - 0328
Querétaro, 76000
Site 0328
- Not yet recruiting
Local Institution - 0629
Tijuana, Estado de Baja California, 22010
Site 0629
- Not yet recruiting
Local Institution - 0615
Zapopan, Jalisco, 45050
Site 0615
Italy12 sites, 12 recruiting
- Recruiting
Cro-Irccs
Aviano, Friuli Venezia Giulia, 33081
Alessandra Bearz, Site 0042, 390434659294
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, 40138
Francesco Gelsomino, Site 0098, +390512142203
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Claudia Proto, Site 0039, 390223903829
- Recruiting
Ospedale San Raffaele
Milan, 20132
Alessandra Bulotta, Site 0045, 390226434856
- Recruiting
AOU della Campania Luigi Vanvitelli
Naples, Campania, 80131
Floriana Morgillo, Site 0105, 390815666728
- Recruiting
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano, Torino, 10043
Silvia Novello, Site 0037, 390119026322
- Recruiting
AO Santa Maria della Misericordia
Perugia, Umbria, 06132
Giulio Metro, Site 0044, 39755784185
- Recruiting
Ospedale Santa Maria delle Croci
Ravenna, Emilia-Romagna, 48121
Manolo DArcangelo, Site 0035, +390544286223
- Not yet recruiting
Local Institution - 0483
Rome, 152
Site 0483
- Not yet recruiting
Local Institution - 0486
Siena, Tuscany, 53100
Site 0486
- Recruiting
Istituto di Candiolo - Fondazione del Piemonte per lOncologia
Turin, 10060
Vanesa Gregorc, Site 0485
- Recruiting
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
Verona, 37134
Lorenzo Belluomini, Site 0468, +390458123876
Romania12 sites, 12 recruiting
- Recruiting
Institutul Oncologic Bucuresti "Prof. Dr. Alexandru Trestioreanu"
Bucharest, Bucharest, 022338
Aurelia Alexandru, Site 0021, 40723289606
- Recruiting
Centrul de Diagnostic si Tratament Provita
Bucharest, 020335
Mircea Dediu, Site 0020, 0040744432443
- Not yet recruiting
Local Institution - 0619
Cluj-Napoca, Cluj, 400001
Site 0619
- Recruiting
Institutul Oncologic Cluj
Cluj-Napoca, 400015
Tudor Ciuleanu, Site 0022, 40745646368
- Recruiting
Institutul Oncologic Cluj
Cluj-Napoca, 400015
Cristina Cebotaru, Site 0023, 40745976913
- Recruiting
Centrul de Oncologie "Sfântul Nectarie"
Craiova, Dolj, 200542
Michael Schenker, Site 0025, 40727774974
- Recruiting
SC Radiotherapy Center Cluj SRL
Florești, Cluj, 407280
Andrei Ungureanu, Site 0019, 40742206212
- Recruiting
S.C. Centrul de Oncologie Euroclinic S.R.L.
Iași, 700106
Constantin Volovat, Site 0031, 40746110096
- Recruiting
Institutul Regional de Oncologie
Iași, 700483
Dana Clement, Site 0026, 40744692062
- Not yet recruiting
Local Institution - 0607
Oradea, Bihor County, 410469
Site 0607
- Recruiting
Radiology Therapeutic Center
Otopeni, Ilfov, 075100
Elena Ciubotaru, Site 0027, 40723171603
- Recruiting
Spitalul Municipal Schuller Ploiești
Ploieşti, 100337
Nita Amedeia, Site 0030, +40728121201
South Korea10 sites, 9 recruiting
- Recruiting
Chungbuk National University Hospital
Cheongju-si, Chungcheongbuk-do [Chungbuk], 28644
Ki Hyeong Lee, Site 0272, 82432696015
- Recruiting
National Cancer Center
Goyang-si, Kyǒnggi-do, 10408
Ji-Youn Han, Site 0271, +82319201154
- Recruiting
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, 13620
Yu Jung Kim, Site 0273, +82-31-787-7041
- Not yet recruiting
Local Institution - 0270
Seoul, Seoul-teukbyeolsi [Seoul], 03080
Site 0270
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [Seoul], 03722
Hye Ryun Kim, Site 0269, 82222284190
- Recruiting
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 05505
Dae Ho Lee, Site 0268, 82230103214
- Recruiting
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 06351
Jin Seok Ahn, Site 0274, 821099333453
- Withdrawn
Local Institution - 0573
Seoul, Seoul-teukbyeolsi [Seoul], 06591
- Recruiting
Seoul St.Mary'S Hospital, The Catholic University Of Korea
Seoul, 06591
SookHee Hong, Site 0471, +82222586045
- Recruiting
Ajou University Hospital
Suwon, Kyǒnggi-do, 16499
Hyun Woo Lee, Site 0571, 82312195142
Spain10 sites, 9 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], 08035
Enriqueta Felip Font, Site 0116, 34932746077
- Withdrawn
Local Institution - 0253
Barcelona, Catalunya [Cataluña], 08036
- Recruiting
Institut Català d'Oncologia - L'Hospitalet
Hospitalet, Barcelona [Barcelona], 08907
Ernest Nadal Alforja, Site 0248, 34932607283
- Recruiting
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, Comunidad de, 28009
Antonio Calles Blanco, Site 0118, +34915868115
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, 28041
Luis Paz-Ares Rodriguez, Site 0254, 0034913908922
- Not yet recruiting
Local Institution - 0480
Madrid, 28046
Site 0480
- Recruiting
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Comunidad de, 28222
Mariano Provencio Pulla, Site 0252, 34911917759
- Recruiting
H.R.U Málaga - Hospital General
Málaga, 29011
Alexandra Cantero Gonzalez, Site 0117, (+34)951308130
- Recruiting
Hospital Universitario Virgen Del Rocio
Seville, 41013
Reyes Bernabe Caro, Site 0256, 34955015273
- Not yet recruiting
Local Institution - 0255
Valencia, 46026
Site 0255
Argentina9 sites, 7 recruiting
- Recruiting
Centro Oncologico Korben
Buenos Aires, 1426
Nicolas Minatta, Site 0447, 5491138018573
- Withdrawn
Local Institution - 0472
Buenos Aires, C1199ABB
- Recruiting
Hospital Británico de Buenos Aires
CABA, Buenos Aires, CP1280AEB
Karina Vera, Site 0446, 1121571056
- Recruiting
Instituto Alexander Fleming
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ
Carmen Pupareli, Site 0465, +541138850425
- Withdrawn
Local Institution - 0568
Lujan de Cuyo, Mendoza Province, 5509
- Not yet recruiting
Local Institution - 0627
Lujan de Cuyo, Mendoza Province, 5509
Site 0627
- Not yet recruiting
Local Institution - 0477
Río Cuarto, Córdoba Province, 5800
Site 0477
- Recruiting
Fundacion Estudios Clinicos
Rosario, Santa Fe Province, 2000
Leticia Bruno, Site 0463, +5493400657764
- Recruiting
Sanatorio Plaza
Rosario, Santa Fe Province, 2000
Natalia Colombo Berra, Site 0618, +5493415599771
Turkey (Türkiye)9 sites, 9 recruiting
- Recruiting
Adana Medical Park Seyhan Hastanesi
Adana, 01140
Ahmet Sezer, Site 0318, 905333616939
- Recruiting
Adana City Hospital
Adana, 01370
Timucin Cil, Site 0317, 905331447619
- Recruiting
Liv Hospital Ankara
Ankara, 06680
Saadettin Kilickap, Site 0321, 905056604536
- Not yet recruiting
Local Institution - 0593
Ankara, 06800
Site 0593
- Not yet recruiting
Local Institution - 0350
Antalya, 07059
Site 0350
- Recruiting
Uludag Universitesi
Bursa, 16059
Erdem Cubukcu, Site 0320, 905325245531
- Not yet recruiting
Local Institution - 0319
Edirne, 22030
Site 0319
- Not yet recruiting
Local Institution - 0595
Istanbul, 34854
Site 0595
- Recruiting
I.E.U. Medical Point Hastanesi
Izmir, Karsiyaka, İzmir, 009035575
Cagatay Arslan, Site 0349, +905052642353
Australia8 sites, 8 recruiting
- Recruiting
Grampians Health
Ballarat Central, Victoria, 3350
Wasek Faisal, Site 0367, 61(03)53208500
- Recruiting
Sunshine Coast University Hospital
Birtinya, Queensland, 4575
Bryan Chan, Site 0382, +61 (0)7 52020000
- Recruiting
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Kenneth O'Byrne, Site 0373, 0731766505
- Recruiting
Lyell McEwin Hospital
Elizabeth Vale, South Australia, 5112
Dainik Patel, Site 0381, 0433217127
- Not yet recruiting
Local Institution - 0368
Garran, ACT 2605
Site 0368
- Recruiting
Royal Hobart Hospital
Hobart, Tasmania, 7000
Rebecca Tay, Site 0431, 61361668308
- Not yet recruiting
Local Institution - 0432
Liverpool, New South Wales, 2170
Site 0432
- Recruiting
GenesisCare St Leonards
St Leonards, New South Wales, 2065
Nick Pavlakis, Site 0591, 61294631172
Greece8 sites, 8 recruiting
- Recruiting
Errikos Dunant Hospital Center
Athens, Attikí, 115 26
IOANNIS MOUNTZIOS, Site 0005, +306983519989
- Recruiting
Thoracic General Hospital of Athens "I Sotiria"
Athens, Attikí, 115 27
Konstantinos Syrigos, Site 0001, +302107700220
- Recruiting
Alexandra General Hospital of Athens
Athens, Attikí, 115 28
Maria Gavriatopoulou, Site 0009, +306934137080
- Recruiting
F. Therapis General
Athens, PC, 11634
Theodoros Tegos, Site 0585
- Recruiting
University General Hospital of Larissa
Larissa, Thessalía, 41110
Athanasios Kotsakis, Site 0003, 302413502124
- Recruiting
University Hospital of Patras
Pátrai, Achaḯa, 26504
Angelos Koutras, Site 0008, 306973801212
- Recruiting
Theagenio Hospital
Thessaloniki, Kentrikí Makedonía, 540 07
Anastasios Boutis, Site 0006, +306937040299
- Recruiting
European Interbalkan Medical Center
Thessaloniki, 57001
Ippokratis Korantzis, Site 0481
India8 sites, 8 recruiting
- Recruiting
Aster CMI Hospital
Bangalore, Karnataka, 560092
C N Patil, Site 0263, 9686444448
- Not yet recruiting
Local Institution - 0344
Bengaluru, Karnataka, 560017
Site 0344
- Recruiting
Apollo Hospitals
Hyderabad, 500033
Nikhil Ghadyalpatil, Site 0265, +918008037474
- Not yet recruiting
Local Institution - 0345
Mumbai, Maharashtra, 400004
Site 0345
- Not yet recruiting
Local Institution - 0266
Mumbai, Maharashtra, 400012
Site 0266
- Not yet recruiting
Local Institution - 0620
Nashik, Maharashtra, 422009
Site 0620
- Not yet recruiting
Local Institution - 0267
New Delhi, National Capital Territory of Delhi, 110029
Site 0267
- Not yet recruiting
Local Institution - 0264
Varanasi, Uttar Pradesh, 221002
Site 0264
Poland8 sites, 6 recruiting
- Recruiting
Centrum Onkologii im. Prof. Franciszka Lukaszczyka
Bydgoszcz, 85796
Bogdan Zurawski, Site 0260, 48501446778
- Not yet recruiting
Local Institution - 0612
Jelenia Góra, Lower Silesian Voivodeship, 58-506
Site 0612
- Withdrawn
Local Institution - 0259
Krakow, Lesser Poland Voivodeship, 30-727
- Recruiting
Centrum Medyczne Pratia Poznań
Poznan, Greater Poland Voivodeship, 60-192
Marek Kotlarski, Site 0262, 512491461
- Recruiting
Szpital Specjalistyczny w Prabutach Spolka z o.o.
Prabuty, Pomeranian Voivodeship, 82-550
Anna Lowczak, Site 0258, +48503022396
- Not yet recruiting
Local Institution - 0594
Warsaw, Masovian Voivodeship, 02-781
Site 0594
- Withdrawn
Local Institution - 0261
Warsaw, Masovian Voivodeship, 04-125
- Recruiting
Mazowiecki Szpital Onkologiczny
Wieliszew, Masovian Voivodeship, 05-135
Renata Biernacka, Site 0458, 509120229
Bulgaria6 sites, 5 recruiting
- Recruiting
Specialized Hospital for Active Treatment of Oncology - Haskovo
Haskovo, 6300
Stoil Boychev, Site 0309, +359889214157
- Withdrawn
Local Institution - 0315
Panagyurishte, Pazardzhik, 4500
- Recruiting
Complex Oncology Center - Ruse EOOD
Rousse, 7002
Nikolay Nikolaev, Site 0308, 0887098616
- Recruiting
University Multidisciplinary Hospital for Active Treatment "St. Ekaterina"
Sofia, 1431
Galina Kurteva, Site 0459, +359887623916
- Recruiting
University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna-ISUL" EAD
Sofia, 1527
Kremena Vasileva, Site 0460, +359887123128
- Recruiting
Trakia Hospital
Stara Zagora, 6000
Rumyana Ilieva, Site 0307, 00359888431354
Israel6 sites, 6 recruiting
- Not yet recruiting
Local Institution - 0016
Afula, Northern District, 1834111
Site 0016
- Recruiting
Rambam Health Care Campus
Haifa, Northern District, 3109601
Alona Zer, Site 0014, 97247776700
- Not yet recruiting
Local Institution - 0017
Jerusalem, Jerusalem, 9013102
Site 0017
- Recruiting
Hadassah Medical Center
Jerusalem, Jerusalem, 9112001
Hovav Nechushtan, Site 0013, 97226777836
- Recruiting
Meir Medical Center
Kfar Saba, Central District, 4428164
Maya Gottfried, Site 0010, 97297472414
- Recruiting
Sheba Medical Center
Ramat Gan, Central District, 5265601
Jair Bar, Site 0011, 97235307096
Belgium5 sites, 5 recruiting
- Recruiting
UZ Brussel
Brussels, 1090
Lore Decoster, Site 0342, 3224775457
- Recruiting
Antwerp University Hospital
Edegem, Antwerpen, 2650
Jo Raskin, Site 0227, 3238213725
- Recruiting
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège, 4000
Pierre FRERES, Site 0340, 003243237801
- Recruiting
AZ Delta vzw
Roeselare, West-Vlaanderen, 8800
Ingel Demedts, Site 0277, 3251237216
- Not yet recruiting
Local Institution - 0225
Yvoir, Namur, 5530
Site 0225
Taiwan5 sites, 5 recruiting
- Recruiting
Chi Mei Hospital - Liouying Branch
Tainan, Tainan, 73657
Cheng-Yao Lin, Site 0114, 8866622699973132
- Recruiting
National Cheng Kung University Hospital
Tainan, 704
Chun-Hui Lee, Site 0111, 886-912777918
- Recruiting
National Taiwan University Hospital
Taipei, 10002
Chia-Chi Lin, Site 0113, 886223123456
- Recruiting
Taipei Medical University Hospital
Taipei, 110
Chao-Hua Chiu, Site 0115, 886227372181-3599
- Recruiting
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
Chen-Yang Huang, Site 0112, +886975361280
Chile4 sites, 4 recruiting
- Not yet recruiting
Local Institution - 0566
Antofagasta, 1240000
Site 0566
- Not yet recruiting
Local Institution - 0473
Providencia, Santiago Metropolitan, 7500713
Site 0473
- Not yet recruiting
Local Institution - 0476
Recoleta, Santiago Metropolitan, 8420000
Site 0476
- Not yet recruiting
Local Institution - 0475
Santiago, 8330015
Site 0475
Hungary4 sites, 4 recruiting
- Not yet recruiting
Local Institution - 0288
Budapest, 1083
Site 0288
- Recruiting
Farkasgyepui Tudogyogyintezet
Farkasgyepű, Veszprém megye, 8582
Zsolt Kiraly, Site 0287, 36209264476
- Not yet recruiting
Local Institution - 0291
Gyöngyös, Heves County, 3200
Site 0291
- Not yet recruiting
Local Institution - 0290
Gyula, Bekes County, 5700
Site 0290
Netherlands4 sites, 3 recruiting
- Withdrawn
Local Institution - 0230
Arnhem, 6815 AD
- Recruiting
University Medical Center Groningen
Groningen, 9713 GZ
T.Jeroen Hiltermann, Site 0249, (3150)361-3532
- Not yet recruiting
Local Institution - 0574
Heerlen, Limburg, 6419PC
Site 0574
- Not yet recruiting
Local Institution - 0445
Veldhoven, North Brabant, 5504 DB
Site 0445
Austria3 sites, 3 recruiting
- Recruiting
Ordensklinikum Linz GmbH Elisabethinen
Linz, Upper Austria, 4020
Michael Schumacher, Site 0208, 4373276763220
- Recruiting
Landeskrankenhaus Rankweil
Rankweil, 6830
Thomas Winder, Site 0210, 004355223032681
- Recruiting
Klinik Floridsdorf
Vienna, 1210
Maximilian Hochmair, Site 0207, +4319106041242
Colombia3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0305
Bogotá, Cundinamarca, 111511
Site 0305
- Not yet recruiting
Local Institution - 0330
Medellín, Antioquia, 050030
Site 0330
- Not yet recruiting
Local Institution - 0306
Montería, Departamento de Córdoba, 230002
Site 0306
Czechia3 sites, 3 recruiting
- Recruiting
Fakultni nemocnice Hradec Kralove
Hradec Králové, Hradec Králové, 500 05
Michal Hrnciarik, Site 0251, +420495834780
- Recruiting
Fakultni nemocnice Olomouc
Olomouc, 779 00
Juraj Kultan, Site 0250, 420588445657
- Recruiting
Nemocnice AGEL Ostrava - Vitkovice a.s.
Ostrava, Ostrava Město, 703 84
Jaromir Roubec, Site 0614, 00420595633400
Norway3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0096
Drammen, Buskerud, 3004
Site 0096
- Not yet recruiting
Local Institution - 0604
Elverum, Innlandet, 2418
Site 0604
- Not yet recruiting
Local Institution - 0603
Oslo, 450
Site 0603
Hong Kong2 sites, 2 recruiting
- Recruiting
Queen Mary Hospital
Hksar, 0
Dennis Leung, Site 0285, 85222554095
- Not yet recruiting
Local Institution - 0323
Shatin, 0
Site 0323
Malaysia2 sites, 2 recruiting
- Recruiting
Sarawak General Hospital
Kuching, Sarawak, 93586
Pei Jye Voon, Site 0390, 6082276666
- Recruiting
University Malaya Medical Centre
Lembah Pantai, Kuala Lumpur, 59100
Jiunn Liang Tan, Site 0413, 60379492299
Thailand2 sites, 2 recruiting
- Recruiting
Chulalongkorn University
Bangkok, Bangkok, 10330
Virote Sriuranpong, Site 0411, 6622564533
- Recruiting
Faculty of Medicine Siriraj Hospital
Bangkok, Bangkok, 10700
Pongwut Danchaivijitr, Site 0412, 6624194488
United Kingdom2 sites, 2 recruiting
- Recruiting
Leicester Royal Infirmary
Leicester, Leicestershire, LE1 5WW
Sean Dulloo, Site 0033, 441162586318
- Recruiting
Sarah Cannon Research Institute UK
London, London, City of, w1g 6ad
Anja Williams, Site 0228, 02032195200
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet University Hospital
Copenhagen, 2100
Edyta Maria Urbanska, Site 0356, 4535450604
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska Universitetssjukhuset
Gothenburg, Västra Götalands Län [se-14], 413 45
Andreas Hallqvist, Site 0097, 46313427954
About this study
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
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
- Being tested
- BMS-986504, Pembrolizumab, Placebo, Cisplatin, Carboplatin
- Keywords
- PRMT5, Lung cancer, NSCLC, MTAP, CDKN2A, MRTX1719, First-line, Navlimetostat
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986504Drug
Specified dose on specified days
PembrolizumabDrug
Specified dose on specified days
PlaceboOther
Specified dose on specified days
CisplatinDrug
Specified dose on specified days
CarboplatinDrug
Specified dose on specified days
PemetrexedDrug
Specified dose on specified days
PaclitaxelDrug
Specified dose on specified days
Nab-paclitaxelDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm A: BMS-986504 + Pembrolizumab + Chemotherapy | Active comparator | Not described Receives: Drug: BMS-986504; Drug: Pembrolizumab; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Nab-paclitaxel |
| Arm B: BMS-986504 + Pembrolizumab + Chemotherapy | Active comparator | Not described Receives: Drug: BMS-986504; Drug: Pembrolizumab; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Nab-paclitaxel |
| Arm C: Placebo + Pembrolizumab + Chemotherapy | Placebo comparator | Not described Receives: Drug: Pembrolizumab; Other: Placebo; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Nab-paclitaxel |
| Arm D: Placebo + Pembrolizumab + Chemotherapy | Placebo comparator | Not described Receives: Drug: Pembrolizumab; Other: Placebo; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Nab-paclitaxel |
| Arm E: BMS-986504 + Pembrolizumab + Chemotherapy | Active comparator | Not described Receives: Drug: BMS-986504; Drug: Pembrolizumab; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Nab-paclitaxel |
| Arm F: Placebo + Pembrolizumab + Chemotherapy | Placebo comparator | Not described Receives: Drug: Pembrolizumab; Other: Placebo; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) by RECIST v1.1
Phase 2
Measured: Up to 2 years
PFS by RECIST v1.1 per BICR
Phase 3
Measured: Up to 5 years
Overall Survival (OS)
Phase 3
Measured: Up to 5 years
Secondary outcomes (12)
Objective response (OR) (confirmed complete response (CR) or partial response (PR))
Phase 2
Measured: Up to 2 years
Disease control (best overall response (BOR) of confirmed CR, confirmed PR, or stable disease (SD))
Phase 2
Measured: Up to 2 years
Duration of response (DOR) (CR or PR)
Phase 2
Measured: Up to 2 years
Time to objective response (TTOR) (CR or PR)
Phase 2
Measured: Up to 2 years
Number of participants with treatment-related and all-cause adverse events (AEs)
Phase 2
Measured: Up to 90 days from the last dose
Number of participants with serious adverse events (SAEs) including fatal AEs
Phase 2
Measured: Up to 90 days from the last dose
Number of participants with adverse events leading to dose interruption, dose reduction, and study treatment discontinuation
Phase 2
Measured: Up to 90 days from the last dose
Number of participants with laboratory abnormalities
Phase 2
Measured: Up to 90 days from the last dose
OR (confirmed CR or PR)
Phase 3
Measured: Up to 5 years
Disease control (BOR of confirmed CR, confirmed PR, or SD)
Phase 3
Measured: Up to 5 years
DOR (CR or PR)
Phase 3
Measured: Up to 5 years
PFS by RECIST v1.1 per Investigator
Phase 3
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start2 Jan 2026
- Primary completion12 Aug 2031 (estimated)
- Study completion12 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Non-small Cell Lung Cancer With MTAP DeletionStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 590 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063745
- Sponsor's protocol ID
- CA240-0029
- Other IDs
- 2025-521511-40, U1111-1319-8383, CA2400029, 2025
- Acronym
- MountainTAP-29
- Status last verified
- Oct 2026
- First submitted
- 3 Jul 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07063745
- Acronym / sponsor ID
- MountainTAP-29 / CA240-0029
- Keywords
- PRMT5, Lung cancer, NSCLC, MTAP, CDKN2A, MRTX1719, First-line, Navlimetostat
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 590 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- 12 Aug 2031 (estimated)
- Study completion
- 12 Aug 2031 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm A: BMS-986504 + Pembrolizumab + Chemotherapy | Active comparator | Drug: BMS-986504, Drug: Pembrolizumab, Drug: Cisplatin, Drug: Carboplatin, Drug: Pemetrexed, Drug: Paclitaxel, Drug: Nab-paclitaxel |
| Arm B: BMS-986504 + Pembrolizumab + Chemotherapy | Active comparator | Drug: BMS-986504, Drug: Pembrolizumab, Drug: Cisplatin, Drug: Carboplatin, Drug: Pemetrexed, Drug: Paclitaxel, Drug: Nab-paclitaxel |
| Arm C: Placebo + Pembrolizumab + Chemotherapy | Placebo comparator | Drug: Pembrolizumab, Other: Placebo, Drug: Cisplatin, Drug: Carboplatin, Drug: Pemetrexed, Drug: Paclitaxel, Drug: Nab-paclitaxel |
| Arm D: Placebo + Pembrolizumab + Chemotherapy | Placebo comparator | Drug: Pembrolizumab, Other: Placebo, Drug: Cisplatin, Drug: Carboplatin, Drug: Pemetrexed, Drug: Paclitaxel, Drug: Nab-paclitaxel |
| Arm E: BMS-986504 + Pembrolizumab + Chemotherapy | Active comparator | Drug: BMS-986504, Drug: Pembrolizumab, Drug: Cisplatin, Drug: Carboplatin, Drug: Pemetrexed, Drug: Paclitaxel, Drug: Nab-paclitaxel |
| Arm F: Placebo + Pembrolizumab + Chemotherapy | Placebo comparator | Drug: Pembrolizumab, Other: Placebo, Drug: Cisplatin, Drug: Carboplatin, Drug: Pemetrexed, Drug: Paclitaxel, Drug: Nab-paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986504Specified dose on specified days | Drug | Arm A: BMS-986504 + Pembrolizumab + Chemotherapy, Arm B: BMS-986504 + Pembrolizumab + Chemotherapy, Arm E: BMS-986504 + Pembrolizumab + Chemotherapy |
| PembrolizumabSpecified dose on specified days | Drug | Arm A: BMS-986504 + Pembrolizumab + Chemotherapy, Arm B: BMS-986504 + Pembrolizumab + Chemotherapy, Arm C: Placebo + Pembrolizumab + Chemotherapy, Arm D: Placebo + Pembrolizumab + Chemotherapy, Arm E: BMS-986504 + Pembrolizumab + Chemotherapy, Arm F: Placebo + Pembrolizumab + Chemotherapy |
| PlaceboSpecified dose on specified days | Other | Arm C: Placebo + Pembrolizumab + Chemotherapy, Arm D: Placebo + Pembrolizumab + Chemotherapy, Arm F: Placebo + Pembrolizumab + Chemotherapy |
| CisplatinSpecified dose on specified days | Drug | Arm A: BMS-986504 + Pembrolizumab + Chemotherapy, Arm B: BMS-986504 + Pembrolizumab + Chemotherapy, Arm C: Placebo + Pembrolizumab + Chemotherapy, Arm D: Placebo + Pembrolizumab + Chemotherapy, Arm E: BMS-986504 + Pembrolizumab + Chemotherapy, Arm F: Placebo + Pembrolizumab + Chemotherapy |
| CarboplatinSpecified dose on specified days | Drug | Arm A: BMS-986504 + Pembrolizumab + Chemotherapy, Arm B: BMS-986504 + Pembrolizumab + Chemotherapy, Arm C: Placebo + Pembrolizumab + Chemotherapy, Arm D: Placebo + Pembrolizumab + Chemotherapy, Arm E: BMS-986504 + Pembrolizumab + Chemotherapy, Arm F: Placebo + Pembrolizumab + Chemotherapy |
| PemetrexedSpecified dose on specified days | Drug | Arm A: BMS-986504 + Pembrolizumab + Chemotherapy, Arm B: BMS-986504 + Pembrolizumab + Chemotherapy, Arm C: Placebo + Pembrolizumab + Chemotherapy, Arm D: Placebo + Pembrolizumab + Chemotherapy, Arm E: BMS-986504 + Pembrolizumab + Chemotherapy, Arm F: Placebo + Pembrolizumab + Chemotherapy |
| PaclitaxelSpecified dose on specified days | Drug | Arm A: BMS-986504 + Pembrolizumab + Chemotherapy, Arm B: BMS-986504 + Pembrolizumab + Chemotherapy, Arm C: Placebo + Pembrolizumab + Chemotherapy, Arm D: Placebo + Pembrolizumab + Chemotherapy, Arm E: BMS-986504 + Pembrolizumab + Chemotherapy, Arm F: Placebo + Pembrolizumab + Chemotherapy |
| Nab-paclitaxelSpecified dose on specified days | Drug | Arm A: BMS-986504 + Pembrolizumab + Chemotherapy, Arm B: BMS-986504 + Pembrolizumab + Chemotherapy, Arm C: Placebo + Pembrolizumab + Chemotherapy, Arm D: Placebo + Pembrolizumab + Chemotherapy, Arm E: BMS-986504 + Pembrolizumab + Chemotherapy, Arm F: Placebo + Pembrolizumab + Chemotherapy |
Primary outcome
Progression-free survival (PFS) by RECIST v1.1
Time frame: Up to 2 years
Phase 2
PFS by RECIST v1.1 per BICR
Time frame: Up to 5 years
Phase 3
Overall Survival (OS)
Time frame: Up to 5 years
Phase 3
12 secondary outcomes
Objective response (OR) (confirmed complete response (CR) or partial response (PR))
Time frame: Up to 2 years
Disease control (best overall response (BOR) of confirmed CR, confirmed PR, or stable disease (SD))
Time frame: Up to 2 years
Duration of response (DOR) (CR or PR)
Time frame: Up to 2 years
Time to objective response (TTOR) (CR or PR)
Time frame: Up to 2 years
Number of participants with treatment-related and all-cause adverse events (AEs)
Time frame: Up to 90 days from the last dose
Number of participants with serious adverse events (SAEs) including fatal AEs
Time frame: Up to 90 days from the last dose
Number of participants with adverse events leading to dose interruption, dose reduction, and study treatment discontinuation
Time frame: Up to 90 days from the last dose
Number of participants with laboratory abnormalities
Time frame: Up to 90 days from the last dose
OR (confirmed CR or PR)
Time frame: Up to 5 years
Disease control (BOR of confirmed CR, confirmed PR, or SD)
Time frame: Up to 5 years
DOR (CR or PR)
Time frame: Up to 5 years
PFS by RECIST v1.1 per Investigator
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
321 sites in 34 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing BMS-986504, Pembrolizumab and Cisplatin in people with Metastatic Non-small Cell Lung Cancer With MTAP Deletion, run by Bristol-Myers Squibb at 321 sites in 34 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 321 sites in United States, China, France, Japan, Germany and 29 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) by RECIST v1.1 (time frame: Up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.