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RecruitingPhase 2Phase 3NCT07063745

A Study to Compare the Combination of 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 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

Sponsor

Bristol-Myers Squibb

Enrollment

590 participants

Start Date

Jan 2, 2026

Study Type

INTERVENTIONAL

Conditions

Metastatic Non-small Cell Lung Cancer With MTAP Deletion

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

Min Age: 18 Years

Inclusion Criteria4

Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease.
Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss.
Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Participants must have at least 1 measurable lesion as per RECIST v1.1.

Exclusion Criteria5

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.

Interventions

DRUGBMS-986504

Specified dose on specified days

DRUGPembrolizumab

Specified dose on specified days

OTHERPlacebo

Specified dose on specified days

DRUGCisplatin

Specified dose on specified days

DRUGCarboplatin

Specified dose on specified days

DRUGPemetrexed

Specified dose on specified days

DRUGPaclitaxel

Specified dose on specified days

DRUGNab-paclitaxel

Specified dose on specified days

Locations(262)

Alaska Oncology and Hematology

Anchorage, Alaska, United States

Mayo Clinic in Arizona - Phoenix

Phoenix, Arizona, United States

Local Institution - 0120

Tucson, Arizona, United States

Highlands Oncology Group

Springdale, Arkansas, United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Local Institution - 0444

Los Angeles, California, United States

Local Institution - 0152

Fort Lauderdale, Florida, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Local Institution - 0430

St. Petersburg, Florida, United States

St. Luke's Cancer Institute: Boise

Boise, Idaho, 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 - 0179

Hawthorne, New York, United States

Local Institution - 0128

Rochester, New York, United States

Local Institution - 0163

Cleveland, Ohio, United States

Local Institution - 0129

Columbus, Ohio, United States

Providence Portland Medical Center

Portland, Oregon, United States

Kaiser Permanente Interstate Medical Office Central

Portland, Oregon, United States

Local Institution - 0433

Dallas, Texas, United States

Local Institution - 0374

El Paso, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Local Institution - 0377

The Woodlands, Texas, United States

Local Institution - 0354

Salt Lake City, Utah, United States

Local Institution - 0131

Fairfax, Virginia, United States

Local Institution - 0186

Richmond, Virginia, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Local Institution - 0465

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0463

Rosario, Santa Fe Province, Argentina

Local Institution - 0447

Buenos Aires, Argentina

Local Institution - 0446

Buenos Aires, Argentina

Local Institution - 0432

Liverpool, New South Wales, Australia

Sunshine Coast University Hospital

Birtinya, Queensland, Australia

Lyell McEwin Hospital

Elizabeth Vale, South Australia, Australia

Local Institution - 0431

Hobart, Tasmania, Australia

Local Institution - 0367

Ballarat Central, Victoria, Australia

Local Institution - 0368

Garran, Australia

Local Institution - 0373

Woolloongabba, Australia

Ordensklinikum Linz GmbH Elisabethinen

Linz, Upper Austria, Austria

Landeskrankenhaus Rankweil

Rankweil, Austria

Local Institution - 0207

Vienna, Austria

Antwerp University Hospital

Edegem, Antwerpen, Belgium

Local Institution - 0226

Hasselt, Limburg, Belgium

Local Institution - 0225

Yvoir, Namur, Belgium

AZ Delta vzw

Roeselare, West-Vlaanderen, Belgium

UZ Brussel

Brussels, Belgium

Local Institution - 0340

Liège, Belgium

Local Institution - 0088

Vitória, Espírito Santo, Brazil

Local Institution - 0079

Natal, Rio Grande do Norte, Brazil

Local Institution - 0346

Porto Alegre, Rio Grande do Sul, Brazil

Local Institution - 0085

Blumenau, Santa Catarina, Brazil

Local Institution - 0081

Barretos, São Paulo, Brazil

Local Institution - 0076

Bauru, São Paulo, Brazil

Local Institution - 0094

Campinas, São Paulo, Brazil

Local Institution - 0355

São Caetano do Sul, São Paulo, Brazil

Local Institution - 0351

São José do Rio Preto, São Paulo, Brazil

Local Institution - 0095

São Paulo, São Paulo, Brazil

Local Institution - 0091

Rio de Janeiro, Brazil

Local Institution - 0078

São Paulo, Brazil

Local Institution - 0315

Panagyurishte, Pazardzhik, Bulgaria

Local Institution - 0459

Sofia, Sofia, Bulgaria

Local Institution - 0309

Haskovo, Bulgaria

Complex Oncology Center - Ruse EOOD

Rousse, Bulgaria

Local Institution - 0460

Sofia, Bulgaria

Local Institution - 0307

Stara Zagora, Bulgaria

Local Institution - 0072

Hefei, Anhui, China

Local Institution - 0074

Beijing, Beijing Municipality, China

Local Institution - 0049

Beijing, Beijing Municipality, China

Local Institution - 0286

Beijing, Beijing Municipality, China

Local Institution - 0046

Fuzhou, Fujian, China

Local Institution - 0100

Xiamen, Fujian, China

Local Institution - 0099

Guangzhou, Guangdong, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Local Institution - 0061

Guangzhou, Guangdong, China

Local Institution - 0281

Shenzhen, Guangdong, China

Guangxi Medical University Affiliated Cancer Hospital

Nanning, Guangxi, China

Local Institution - 0408

Guiyang, Guizhou, China

Local Institution - 0353

Shijiazhuang, Hebei, China

Local Institution - 0106

Harbin, Heilongjiang, China

Local Institution - 0107

Zhengzhou, Henan, China

Wuhan Union Hospital Cancer Center

Wuhan, Hubei, China

Local Institution - 0059

Wuhan, Hubei, China

Local Institution - 0387

Changsha, Hunan, China

Local Institution - 0050

Changsha, Hunan, China

Local Institution - 0352

Nanjing, Jiangsu, China

Local Institution - 0279

Nanjing, Jiangsu, China

Nanjing First Hospital

Nanjing, Jiangsu, China

Local Institution - 0110

Nanchang, Jiangxi, China

Local Institution - 0284

Shenyang, Liaoning, China

Local Institution - 0104

Shenyang, Liaoning, China

Liaoning Cancer Hospital

Shenyang, Liaoning, China

Local Institution - 0060

Xi'an, Shaanxi, China

Local Institution - 0051

Jinan, Shandong, China

Local Institution - 0066

Linyi, Shandong, China

Local Institution - 0068

Qingdao, Shandong, China

Local Institution - 0278

Shanghai, Shanghai Municipality, China

Zhongshan Hospital,Fudan University

Shanghai, Shanghai Municipality, China

Local Institution - 0283

Taiyuan, Shanxi, China

Sichuan Cancer hospital

Chengdu, Sichuan, China

West China Hospital Sichuan University

Chengdu, Sichuan, China

Local Institution - 0280

Hangzhou, Zhejiang, China

Local Institution - 0069

Hangzhou, Zhejiang, China

Local Institution - 0054

Hangzhou, Zhejiang, China

Local Institution - 0047

Zhengzhou, China

Local Institution - 0330

Medellín, Antioquia, Colombia

Local Institution - 0305

Bogotá, Cundinamarca, Colombia

Local Institution - 0306

Montería, Departamento de Córdoba, Colombia

Fakultni nemocnice Hradec Kralove

Hradec Králové, Hradec Králové, Czechia

Local Institution - 0250

Olomouc, Czechia

Local Institution - 0356

Copenhagen, Capital Region, Denmark

CHU Bordeaux Haut-Leveque

Pessac, Aquitaine, France

Centre François Baclesse

Caen, Calvados, France

Local Institution - 0212

Dijon, Côte-d'Or, France

Chu Jean Minjoz

Besançon, Doubs, France

CHRU de Brest

Brest, Finistère, France

CHU de Toulouse - Hopital Larrey

Toulouse, Haute-Garonne, France

Local Institution - 0220

Montpellier, Hérault, France

Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou

Rennes, Ille-et-Vilaine, France

Local Institution - 0215

Saint-Herblain, Loire-Atlantique, France

Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France

Institut Paoli-Calmettes

Marseille, Provence-Alpes-Côte d'Azur Region, France

Chu Gabriel Montpied

Clermont-Ferrand, Puy-de-Dôme, France

Hospices Civils de Lyon - Hopital Louis Pradel

Bron, Rhône, France

Local Institution - 0213

Créteil, Val-de-Marne, France

Institut Curie

Paris, France

Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau

Tours, France

Local Institution - 0429

Paris, Île-de-France Region, France

Local Institution - 0461

Göppingen, Baden-Wurttemberg, Germany

Robert Bosch Krankenhaus GmbH

Stuttgart, Baden-Wurttemberg, Germany

Local Institution - 0462

Ulm, Baden-Wurttemberg, Germany

Local Institution - 0202

München, Bavaria, Germany

Krankenhaus Barmherzige Brüder Regensburg

Regensburg, Bavaria, Germany

Pius Hospital Oldenburg

Oldenburg, Lower Saxony, Germany

LungenClinic Grosshansdorf

Großhansdorf, Germany

Lungenfachklinik Immenhausen

Immenhausen, Germany

Klinik Löwenstein

Löwenstein, Germany

University Hospital of Patras

Pátrai, Achaḯa, Greece

Local Institution - 0005

Athens, Attikí, Greece

Thoracic General Hospital of Athens "I Sotiria"

Athens, Attikí, Greece

Alexandra General Hospital of Athens

Athens, Attikí, Greece

Local Institution - 0006

Thessaloniki, Kentrikí Makedonía, Greece

University General Hospital of Larissa

Larissa, Thessalía, Greece

Queen Mary Hospital

Hksar, Hong Kong

Local Institution - 0323

Shatin, Hong Kong

Local Institution - 0290

Gyula, Bekes County, Hungary

Local Institution - 0291

Gyöngyös, Heves County, Hungary

Local Institution - 0287

Farkasgyepű, Veszprém megye, Hungary

Local Institution - 0288

Budapest, Hungary

Local Institution - 0263

Bangalore, Karnataka, India

Local Institution - 0344

Bengaluru, Karnataka, India

Local Institution - 0345

Mumbai, Maharashtra, India

Local Institution - 0266

Mumbai, Maharashtra, India

Local Institution - 0267

New Delhi, National Capital Territory of Delhi, India

Local Institution - 0265

Hyderabad, Telangana, India

Local Institution - 0264

Varanasi, Uttar Pradesh, India

Local Institution - 0010

Kfar Saba, Central District, Israel

Local Institution - 0011

Ramat Gan, Central District, Israel

Local Institution - 0017

Jerusalem, Jerusalem, Israel

Local Institution - 0013

Jerusalem, Jerusalem, Israel

Local Institution - 0016

Afula, Northern District, Israel

Local Institution - 0014

Haifa, Northern District, Israel

Local Institution - 0105

Napoli, Campania, Italy

Ospedale Santa Maria delle Croci

Ravenna, Emilia-Romagna, Italy

Cro-Irccs

Aviano, Friuli Venezia Giulia, Italy

Azienda Ospedaliero-Universitaria San Luigi Gonzaga

Orbassano, Torino, Italy

Local Institution - 0044

Perugia, Umbria, Italy

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

Bologna, Italy

Local Institution - 0039

Milan, Italy

Ospedale San Raffaele

Milan, Italy

Local Institution - 0468

Verona, Italy

Local Institution - 0243

Nagoya, Aichi-ken, Japan

Local Institution - 0236

Kashiwa, Chiba, Japan

Local Institution - 0334

Otashi, Gunma, Japan

Local Institution - 0233

Sapporo, Hokkaido, Japan

Local Institution - 0336

Himeji, Hyōgo, Japan

Local Institution - 0247

Kobe, Hyōgo, Japan

Local Institution - 0335

Shiwa-gun Yahaba-cho, Iwate, Japan

Local Institution - 0257

Kawasaki, Kanagawa, Japan

Local Institution - 0238

Yokohama, Kanagawa, Japan

Local Institution - 0241

Nankoku, Kochi, Japan

Local Institution - 0237

Matsusaka, Mie-ken, Japan

Local Institution - 0232

Sendai, Miyagi, Japan

Local Institution - 0240

Hirakata, Osaka, Japan

Local Institution - 0245

Hidaka, Saitama, Japan

Local Institution - 0235

Shimotsuga, Tochigi, Japan

Local Institution - 0234

Bunkyo-ku, Tokyo, Japan

Local Institution - 0242

Ube, Yamaguchi, Japan

Local Institution - 0246

Fukuoka, Japan

Local Institution - 0244

Okayama, Japan

Local Institution - 0239

Osaka, Japan

Local Institution - 0413

Kuala Lumpur, Kuala Lumpur, Malaysia

Local Institution - 0390

Kuching, Sarawak, Malaysia

Local Institution - 0296

Guadalajara, Jalisco, Mexico

Local Institution - 0326

Guadalajara, Jalisco, Mexico

Local Institution - 0293

Mexico City, Mexico City, Mexico

Local Institution - 0294

Mexico City, Mexico City, Mexico

Local Institution - 0298

Monterrey, Nuevo León, Mexico

Local Institution - 0297

Oaxaca City, Oaxaca, Mexico

Local Institution - 0327

Chihuahua City, Mexico

Local Institution - 0331

Puebla City, Mexico

Local Institution - 0328

Querétaro, Mexico

Local Institution - 0445

Veldhoven, North Brabant, Netherlands

Local Institution - 0230

Arnhem, Netherlands

University Medical Center Groningen

Groningen, Netherlands

Local Institution - 0096

Drammen, Buskerud, Norway

Centrum Medyczne Pratia Poznań

Poznan, Greater Poland Voivodeship, Poland

Local Institution - 0259

Krakow, Lesser Poland Voivodeship, Poland

Local Institution - 0261

Warsaw, Masovian Voivodeship, Poland

Local Institution - 0458

Wieliszew, Masovian Voivodeship, Poland

Szpital Specjalistyczny w Prabutach Spolka z o.o.

Prabuty, Pomeranian Voivodeship, Poland

Centrum Onkologii im. Prof. Franciszka Lukaszczyka

Bydgoszcz, Poland

Institutul Oncologic Bucuresti "Prof. Dr. Alexandru Trestioreanu"

Bucharest, București, Romania

SC Radiotherapy Center Cluj SRL

Florești, Cluj, Romania

Centrul de Oncologie "Sfântul Nectarie"

Craiova, Dolj, Romania

Radiology Therapeutic Center

Otopeni, Ilfov, Romania

Centrul de Diagnostic si Tratament Provita

Bucharest, Romania

Institutul Oncologic Cluj

Cluj-Napoca, Romania

Institutul Oncologic Cluj

Cluj-Napoca, Romania

S.C. Centrul de Oncologie Euroclinic S.R.L.

Iași, Romania

Institutul Regional de Oncologie

Iași, Romania

Spitalul Municipal Schuller Ploiești

Ploieşti, Romania

Local Institution - 0272

Cheongju-si, Chungcheongbuk-do [Chungbuk], South Korea

National Cancer Center

Goyang-si, Kyǒnggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, South Korea

Local Institution - 0270

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Asan Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Local Institution - 0471

Seoul, South Korea

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], Spain

Local Institution - 0248

Hospitalet, Barcelona [Barcelona], Spain

Local Institution - 0253

Barcelona, Catalunya [Cataluña], Spain

Local Institution - 0118

Madrid, Madrid, Comunidad de, Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad de, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, Comunidad de, Spain

H.R.U Málaga - Hospital General

Málaga, Spain

Hospital Universitario Virgen Del Rocio

Seville, Spain

Local Institution - 0255

Valencia, Spain

Sahlgrenska Universitetssjukhuset

Gothenburg, Västra Götalands Län [se-14], Sweden

Chi Mei Hospital - Liouying Branch

Tainan, Tainan, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan District, Taiwan

Local Institution - 0411

Bangkok, Thailand

Local Institution - 0412

Bangkok, Thailand

Local Institution - 0349

Izmir, Karsiyaka, İzmir, Turkey (Türkiye)

Local Institution - 0318

Adana, Turkey (Türkiye)

Local Institution - 0317

Adana, Turkey (Türkiye)

Local Institution - 0321

Ankara, Turkey (Türkiye)

Local Institution - 0350

Antalya, Turkey (Türkiye)

Local Institution - 0320

Bursa, Turkey (Türkiye)

Local Institution - 0319

Edirne, Turkey (Türkiye)

Leicester Royal Infirmary

Leicester, Leicestershire, United Kingdom

Sarah Cannon Research Institute UK

London, London, City of, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

NCT07063745