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NCT07361510PHASE3Recruiting

A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202)

Bristol-Myers Squibb

Start Date

3/12/2026

Completion Date

10/14/2031

Summary

The purpose of this study is to evaluate the efficacy of Pumitamig versus Pembrolizumab in participants with previously untreated advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria * Participants must have a histologically or cytologically confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC) (squamous and nonsquamous) with Stage IIIB/IIIC or Stage IV disease. * Participants must have a programmed death ligand-1 (PD-L1) expression ≥ 50%. * Participants must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * Participants must have no prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC. * Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. Exclusion Criteria * Participants must not have any documented actionable genomic alteration (AGA) for which first-line (1L) approved therapies are indicated. * Participants must not have any symptomatic untreated central nervous system (CNS) metastases, leptomeningeal metastases (carcinomatous meningitis) or spinal cord compression. * Participants must not have any significant cardiovascular impairment as evidenced by uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias, or major thrombotic or embolic events or major hemorrhagic events (within 6 months prior to randomization), or significant risk of pulmonary hemorrhage. * Participants must not an active autoimmune disease. * Other protocol-defined Inclusion/Exclusion criteria apply.

Interventions

DRUG

Pumitamig

DRUG

Pembrolizumab

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Conditions

Non-Small Cell Lung Cancer (NSCLC)

Locations

Southern Cancer Center Pc

Daphne, Alabama 36526

United States

Mohtaseb Cancer Center & Blood Disorders

Bullhead City, Arizona 86442

United States

Palo Verde Hematology Oncology

Glendale, Arizona 85304

United States

Local Institution - 0407

Anaheim, California 92801

United States

Local Institution - 0352

Beverly Hills, California 90211

United States

Orange Coast Memorial Medical Center

Fountain Valley, California 92708

United States

Local Institution - 0027

Los Alamitos, California 90720

United States

Local Institution - 0422

Los Angeles, California 90095

United States

Local Institution - 0403

Oakland, California 94611

United States

Local Institution - 0208

Pleasant Hill, California 94523

United States

Local Institution - 0416

Walnut Creek, California 94598

United States

Local Institution - 0340

Lakewood, Colorado 80401

United States

Clermont Oncology Center

Clermont, Florida 34711

United States

Advanced Research

Coral Springs, Florida 33321

United States

BRP- Hialeah Hospital

Hialeah, Florida 33013

United States

Florida Clinical Trials Group

Tamarac, Florida 33321

United States

University Cancer & Blood Center, LLC

Athens, Georgia 30607

United States

Local Institution - 0412

Augusta, Georgia 30912

United States

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

Marietta, Georgia 30060

United States

Local Institution - 0423

Urbana, Illinois 61801

United States

Northwest Cancer Centers, P.C.

Dyer, Indiana 46311

United States

Missouri Cancer Associates

Columbia, Missouri 65201

United States

Local Institution - 0224

Laurelton, New York 11413

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Optum Medical Care, PC

Westbury, New York 11590

United States

Local Institution - 0283

Winston-Salem, North Carolina 27103

United States

Local Institution - 0383

Cincinnati, Ohio 45220

United States

Local Institution - 0418

Oklahoma City, Oklahoma 73109

United States

Local Institution - 0288

Lancaster, Pennsylvania 17601

United States

Local Institution - 0028

Pittsburgh, Pennsylvania 15212

United States

WellSpan Oncology Research

York, Pennsylvania 17403

United States

University Of Texas Medical Branch At Galveston

Galveston, Texas 77555

United States

Kelsey-Seybold Clinic Main Campus

Houston, Texas 77025

United States

Texas Oncology - San Antonio

San Antonio, Texas 78217

United States

Local Institution - 0381

San Antonio, Texas 78260

United States

Local Institution - 0337

Richmond, Virginia 23298

United States

Shenandoah Oncology, P.C.

Winchester, Virginia 22601

United States

Local Institution - 0384

Spokane, Washington 99218

United States

Local Institution - 0339

Charleston, West Virginia 25304

United States

HSHS St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin 54301

United States

Local Institution - 0421

Marshfield, Wisconsin 54449

United States

Local Institution - 0076

Mar del Plata, Buenos Aires B7600FZN

Argentina

Fundacion Estudios Clinicos

Rosario, Santa Fe Province 2000

Argentina

Sanatorio Plaza

Rosario, Santa Fe Province 2000

Argentina

Local Institution - 0420

San Miguel de Tucumán, Tucumán Province T4000IHE

Argentina

Local Institution - 0058

Buenos Aires, 1430

Argentina

Local Institution - 0374

Córdoba, X5000BAL

Argentina

Gosford Hospital

Gosford, New South Wales 2250

Australia

Nepean Hospital

Penrith, New South Wales 2750

Australia

Lyell McEwin Hospital

Elizabeth Vale, South Australia 5112

Australia

Local Institution - 0201

Epping, Victoria 3076

Australia

Grampians Health

Mount Waverley, Victoria 3149

Australia

Joondalup Health Campus

Joondalup, Western Australia 6027

Australia

Kepler Universitaetsklinikum

Linz, Upper Austria 4021

Austria

Local Institution - 0196

Feldkirch, 6800

Austria

Universitätsklinikum St. Pölten

Sankt Pölten, 3100

Austria

ZAS Augustinus

Wilrijk, Antwerpen 2610

Belgium

Local Institution - 0333

Auderghem, Bruxelles-Capitale, Région de 1160

Belgium

Local Institution - 0109

Leuven, Vlaams-Brabant 3000

Belgium

Algemeen Ziekenhuis klina

Brasschaat, 2930

Belgium

Local Institution - 0148

Fortaleza, Ceará 60336-045

Brazil

Local Institution - 0066

Natal/RN, Rio Grande do Norte 59062-000

Brazil

Local Institution - 0245

Porto Alegre, Rio Grande do Sul 90110-270

Brazil

Fundação Pio XII - Hospital de Câncer de Barretos

Barretos, São Paulo 14784400

Brazil

Local Institution - 0375

São Paulo, São Paulo 01509-010

Brazil

Local Institution - 0090

Taubaté, São Paulo 12030-200

Brazil

Centro Paulista de Oncologia Clínica

São Paulo, 01452-000

Brazil

Complex Oncology Center - Ruse EOOD

Rousse, 7002

Bulgaria

Local Institution - 0326

Sofia, 1431

Bulgaria

Local Institution - 0047

Sofia, 1527

Bulgaria

Local Institution - 0325

Sofia, 1680

Bulgaria

Local Institution - 0411

Prince George, British Columbia V2M7E9

Canada

Local Institution - 0002

Halifax, Nova Scotia B3H 3A7

Canada

Local Institution - 0414

Oshawa, Ontario L1G2B9

Canada

Local Institution - 0178

Ottawa, Ontario K1H 8L6

Canada

Local Institution - 0156

Toronto, Ontario M6R 1B5

Canada

Local Institution - 0361

Antofagasta, AN 1240000

Chile

Local Institution - 0302

Las Condes, Arica y Parinacota Region 7560908

Chile

Local Institution - 0199

Santiago, Santiago Metropolitan 8420383

Chile

Local Institution - 0293

Concepción, 4070196

Chile

Local Institution - 0150

Independencia, 8380455

Chile

Local Institution - 0175

Beijing, Beijing Municipality 100142

China

Fujian Cancer Hospital

Fuzhou, Fujian 350014

China

Local Institution - 0141

Xiamen, Fujian 361003

China

Local Institution - 0327

Zhangzhou, Fujian 363000

China

Local Institution - 0312

Guangzhou, Guangdong 510515

China

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong 515041

China

Guangxi Medical University Affiliated Tumor Hospital

Nanning, Guangxi 530021

China

Local Institution - 0317

Harbin, Heilongjiang 150081

China

Local Institution - 0046

Zhengzhou, Henan 450008

China

Local Institution - 0004

Changsha, Hunan 410013

China

Local Institution - 0117

Nanjing, Jiangsu 210000

China

Local Institution - 0316

Nanjing, Jiangsu 210009

China

Local Institution - 0023

Nanchang, Jiangxi 330006

China

Local Institution - 0177

Shenyang, Liaoning 110042

China

Local Institution - 0014

Xi'an, Shaanxi 710038

China

Shandong Cancer Hospital

Jinan, Shandong 250117

China

Local Institution - 0123

Linyi, Shandong 276001

China

Shanghai East Hospital

Shanghai, Shanghai Municipality 200120

China

Local Institution - 0212

Shanghai Shi, Shanghai Municipality 201700

China

Local Institution - 0246

Chengdu, Sichuan 610041

China

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang 310016

China

Local Institution - 0089

Hangzhou, Zhejiang 310052

China

Local Institution - 0113

Beijing, 100021

China

Local Institution - 0122

Shanghai Shi, 200030

China

Local Institution - 0310

Rionegro, Antioquia 054047

Colombia

Local Institution - 0328

Barranquilla, Atlántico 80020

Colombia

Local Institution - 0218

Bogotá,

Colombia

Local Institution - 0307

Medellín, 050034

Colombia

Local Institution - 0092

Ostrava, Moravian-Silesian 70384

Czechia

Local Institution - 0129

Pilsen, Plzeň Region 305 99

Czechia

Local Institution - 0243

Hradec Králové, 500 05

Czechia

Local Institution - 0236

Olomouc, 77520

Czechia

Kuopion Yliopistollinen Sairaala

Kuopio, Northern Savonia 70200

Finland

Tampereen yliopistollinen sairaala

Tampere, 33521

Finland

Vaasan Keskussairaala

Vaasa, 65130

Finland

Local Institution - 0398

Nice, Alpes-Maritimes 06189

France

CHU Bordeaux Haut-Leveque

Pessac, Aquitaine 33600

France

Local Institution - 0162

Lille, Hauts-de-France 59037

France

Local Institution - 0239

Montpellier, Hérault 34298

France

Local Institution - 0144

La Tronche, Isère 38700

France

Local Institution - 0057

Saint-Herblain, Loire-Atlantique 44805

France

Local Institution - 0059

Toulouse, Midi-Pyrénées 31400

France

Local Institution - 0397

Dijon, 21079

France

Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren

Limoges, 87042

France

Local Institution - 0151

Marseille, 13915

France

Hopitaux Universitaires Paris Centre-Hopital Cochin

Paris, 75679

France

Centre Hospitalier de Cornouaille Quimper - Concarneau

Quimper, 29000

France

Institut Jean Godinot

Reims, 51726

France

Local Institution - 0207

Paris, Île-de-France Region 75014

France

Fachkliniken Wangen

Wangen, Baden-Wurttemberg 88239

Germany

VK&K Studien GbR

Landshut, Bavaria 84036

Germany

RoMed Klinikum Rosenheim

Rosenheim, Bavaria 83022

Germany

Local Institution - 0357

Kaiserslautern, Deutschland 67655

Germany

Gemeinschaftspraxis für Hämatologie und Onkologie

Langen, Hesse 63225

Germany

Local Institution - 0433

Wiesbaden, Hesse 65199

Germany

Local Institution - 0432

Cologne, North Rhine-Westphalia 51109

Germany

Local Institution - 0428

Dortmund, North Rhine-Westphalia 44263

Germany

Local Institution - 0187

Solingen, North Rhine-Westphalia 42699

Germany

Local Institution - 0172

Kiel, Schleswig-Holstein 24105

Germany

HELIOS Klinikum Erfurt

Erfurt, Thuringia 99089

Germany

Local Institution - 0231

Berlin, 14165

Germany

Local Institution - 0158

Braunschweig, 38114

Germany

Local Institution - 0073

Essen, 45136

Germany

Local Institution - 0103

Gera, 07548

Germany

Local Institution - 0071

Göttingen, 37075

Germany

Local Institution - 0083

Sindelfingen, 71065

Germany

Local Institution - 0240

Budapest, 1121

Hungary

Local Institution - 0012

Farkasgyepű, 8582

Hungary

Local Institution - 0244

Mátraháza, 3233

Hungary

Local Institution - 0241

Szolnok, 5004

Hungary

Local Institution - 0303

Eluru, Andhra Pradesh 534002

India

Local Institution - 0319

Visakhapatnam, Andhra Pradesh 530053

India

Local Institution - 0427

Goraj, Gujarat 391760

India

Local Institution - 0219

Mumbai, Maharashtra 400012

India

Local Institution - 0015

Mumbai, Maharashtra 400036

India

Local Institution - 0008

Nagpur, Maharashtra 440001

India

Local Institution - 0125

Dwarka, National Capital Territory of Delhi 110075

India

Local Institution - 0020

Hyderabad, Telangana 500033

India

Local Institution - 0078

Delhi, 110029

India

Local Institution - 0036

Pune, 411001

India

AOU di Ferrara Arcispedale S. Anna

Ferrara (Cona), Emilia-Romagna 44124

Italy

Cro-Irccs

Aviano, Friuli Venezia Giulia 33081

Italy

Local Institution - 0279

Catania, Sicily 95123

Italy

Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia

Candiolo, Torino 10060

Italy

Local Institution - 0111

Genova, 16132

Italy

Local Institution - 0033

Milan, 20132

Italy

Local Institution - 0040

Naples, 80131

Italy

Azienda Ospedaliero Universitaria Maggiore della Carità

Novara, 28100

Italy

Toyohashi Municipal Hospital

Toyohashi, Aichi-ken 441-8570

Japan

Funabashi Municipal Medical Center

Funabashi, Chiba 273-0853

Japan

Local Institution - 0256

Tōon, Ehime 791-0295

Japan

Sapporo Minami-Sanjo Hospital

Sapporo, Hokkaido 060-0063

Japan

Hyogo Medical University Hospital

Nishinomiya, Hyōgo 663-8501

Japan

Ishikawa Prefectural Central Hospital

Kanazawa, Ishikawa-ken 920-8530

Japan

Shonan Kamakura General Hospital

Kamakura, Kanagawa 247-8533

Japan

Kanagawa cancer center

Yokohama, Kanagawa 2418515

Japan

Local Institution - 0257

Sendai, Miyagi 980-8574

Japan

Sendai Kousei Hospital

Sendai, Miyagi 9810914

Japan

Kindai University Hospital

Sakai, Osaka 590-0197

Japan

Saitama Medical University International Medical Center

Hidaka, Saitama 350-1298

Japan

Dokkyo Medical University Saitama Medical Center

Koshigaya, Saitama 3438555

Japan

Aomori Prefectural Central Hospital

Aomori, 030-8553

Japan

Hamamatsu University Hospital

Hamamatsu, 431-3192

Japan

Local Institution - 0252

Hirakata-shi, 573-1191

Japan

Hiroshima Prefectural Hospital

Hiroshima, 734-8530

Japan

Saiseikai Kumamoto Hospital

Kumamoto, 861-4193

Japan

Local Institution - 0275

George Town, Pulau Pinang 10990

Malaysia

Local Institution - 0271

Kuching, Sarawak 93586

Malaysia

Local Institution - 0277

Kuala Lumpur, 50603

Malaysia

Local Institution - 0070

Zapopan, Jalisco 45050

Mexico

Local Institution - 0075

Mexico City, Mexico City 04700

Mexico

Local Institution - 0386

Monterrey, Nuevo León 64623

Mexico

Local Institution - 0385

Mexico City, 14210

Mexico

Local Institution - 0097

Oaxaca City, 68020

Mexico

Local Institution - 0124

Querétaro, 76000

Mexico

Local Institution - 0110

Nijmegen, Gelderland 6525 GA

Netherlands

Local Institution - 0286

Breda, North Brabant 4818 CK

Netherlands

Local Institution - 0100

's-Hertogenbosch, 5211 NL

Netherlands

Meander Medisch Centrum

Amersfoort, 3813 TZ

Netherlands

Local Institution - 0261

Deventer, 7400 GC

Netherlands

ETZ Elisabeth

Tilburg, 5022 GC

Netherlands

Østfold Hopsital, Kalnes

Grålum, Akershus 1714

Norway

Drammen Sykehus, Vestre Viken HF

Drammen, Buskerud 3004

Norway

Local Institution - 0121

San Borja, Lima region 15034

Peru

Local Institution - 0155

Lima, 27

Peru

Local Institution - 0296

Lima, Lima 41

Peru

Local Institution - 0041

Opole, Opole Voivodeship 45-061

Poland

Local Institution - 0227

Przemyśl, Podkarpackie Voivodeship 37-700

Poland

Local Institution - 0105

Katowice, 40-514

Poland

Local Institution - 0329

Katowice, 40-519

Poland

Local Institution - 0186

Lodz, 93-338

Poland

Unidade Local de Saúde de Braga

Braga, 4710-243

Portugal

Unidade Local de Saúde Santa Maria - Lisboa

Lisbon, 1769-001

Portugal

Centrul de Diagnostic si Tratament Provita

Bucharest, Bucharest 020335

Romania

SC Radiotherapy Center Cluj SRL

Florești, Cluj 407280

Romania

Centrul de Oncologie "Sfântul Nectarie"

Craiova, Dolj 200542

Romania

Oncohelp Medical Center

Timișoara, Timiș County 300239

Romania

Local Institution - 0191

Baloteşti, 77015

Romania

Spitalul Clinic Colțea

Bucharest, 030171

Romania

Local Institution - 0136

Bucharest, 050098

Romania

Institutul Oncologic Cluj

Cluj-Napoca, 400015

Romania

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

Iași, 700106

Romania

Institutul Regional de Oncologie

Iași, 700483

Romania

Local Institution - 0267

Singapore, 169610

Singapore

Local Institution - 0269

Singapore, 308442

Singapore

Pusan National University Yangsan Hospital

Busan, Kyǒngsangnam-do 50612

South Korea

Konkuk University Medical Center

Seoul, Seoul-teukbyeolsi [Seoul] 05030

South Korea

Kyungpook National University Chilgok Hospital

Deagu, Taegu-Kwangyǒkshi 41404

South Korea

Chungnam national university hospital

Junggu, Taejǒn-Kwangyǒkshi 35015

South Korea

Parc de Salut Mar - Hospital del Mar

Barcelona, Barcelona [Barcelona] 08003

Spain

OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces

Barakaldo, Basque Country 48903

Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalunya [Cataluña] 08041

Spain

Hospital Universitario de Jaen

Jaén, 23007

Spain

Local Institution - 0266

Madrid, 28006

Spain

Hospital Clinico San Carlos

Madrid, 28040

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Hospital Universitario Virgen de la Victoria

Málaga, 29010

Spain

Hospital General Universitario Morales Meseguer

Murcia, 30008

Spain

Local Institution - 0039

Stockholm, Stockholm County 17176

Sweden

Local Institution - 0010

Gävle, 801 87

Sweden

Centre Hospitalier Universitaire Vaudois

Lausanne, 1011

Switzerland

Local Institution - 0053

Sankt Gallen, 9007

Switzerland

Onkologiezentrum Thun-Berner Oberland Spital Sts Ag

Thun, 3600

Switzerland

Local Institution - 0262

Villars-sur-Glâne, 1752

Switzerland

Chang Gung Memorial Hospital at Kaohsiung

Kaohsiung Niao Sung Dist, Kaohsiung 83301

Taiwan

Local Institution - 0387

Kaohsiung City, 82445

Taiwan

Far Eastern Memorial Hospital

New Taipei City, 220

Taiwan

Taichung Veterans General Hospital

Taichung, 407

Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, 333

Taiwan

Local Institution - 0272

Bangkok, 10700

Thailand

Local Institution - 0405

Chiang Mai, 50200

Thailand

Local Institution - 0273

Khon Kaen, 40002

Thailand

Local Institution - 0274

Songkhla, 90110

Thailand

Local Institution - 0242

Adana, 01123

Turkey (Türkiye)

Local Institution - 0091

Adana, 1370

Turkey (Türkiye)

Local Institution - 0415

Ankara, 06800

Turkey (Türkiye)

Local Institution - 0118

Antalya, 07100

Turkey (Türkiye)

Local Institution - 0235

Cordaleo, 35000

Turkey (Türkiye)

Local Institution - 0238

Çankaya, 06680

Turkey (Türkiye)

Local Institution - 0107

Istanbul, 34214

Turkey (Türkiye)

Local Institution - 0017

Istanbul, 34295

Turkey (Türkiye)

Local Institution - 0133

Istanbul, 34732

Turkey (Türkiye)

Local Institution - 0367

Istanbul, 34899

Turkey (Türkiye)

Local Institution - 0364

Izmir, 35110

Turkey (Türkiye)

Aberdeen Royal Infirmary

Aberdeen, Aberdeenshire AB25 2ZN

United Kingdom

Local Institution - 0112

Middlesbrough, Cleveland TS4 3BW

United Kingdom

Local Institution - 0426

Norwich, East NR47UY

United Kingdom

The Royal Marsden NHS Foundation Trust

Sutton, South East SM25PT

United Kingdom

Addenbrooke's Hospital

Cambridge, CB2 2QQ

United Kingdom

Velindre Cancer Centre

Cardiff, CF14 2TL

United Kingdom

The Royal Surrey County Hospital NHS Foundation Trust

Guildford, GU2 7XX

United Kingdom

Royal Marsden Hospital (Chelsea)

London, SW3 6JJ

United Kingdom

Royal Wolverhampton Nhs Trust

Wolverhampton, WV10 0QP

United Kingdom