RecruitingPhase 3NCT07361510

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)

ROSETTA Lung-202: A Randomized, Double-Blind, Phase 3 Study of Pumitamig Monotherapy Compared to Pembrolizumab as First-line Treatment in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With PD-L1 ≥ 50%.

Sponsor

Bristol-Myers Squibb

Enrollment

750 participants

Start Date

Mar 12, 2026

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer (NSCLC)

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Pembrolizumab and a drug called Pumitamig for people with non-small cell lung cancer (nsclc). The study is currently recruiting participants at 272 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPumitamig

Specified dose on specified days

DRUGPembrolizumab

Specified dose on specified days

Locations(274)

Southern Cancer Center Pc

Daphne, Alabama, United States

Mohtaseb Cancer Center & Blood Disorders

Bullhead City, Arizona, United States

Palo Verde Hematology Oncology

Glendale, Arizona, United States

Local Institution - 0407

Anaheim, California, United States

Local Institution - 0352

Beverly Hills, California, United States

Orange Coast Memorial Medical Center

Fountain Valley, California, United States

Local Institution - 0027

Los Alamitos, California, United States

Local Institution - 0422

Los Angeles, California, United States

Local Institution - 0403

Oakland, California, United States

Local Institution - 0208

Pleasant Hill, California, United States

Local Institution - 0416

Walnut Creek, California, United States

Local Institution - 0340

Lakewood, Colorado, United States

Clermont Oncology Center

Clermont, Florida, United States

Advanced Research

Coral Springs, Florida, United States

BRP- Hialeah Hospital

Hialeah, Florida, United States

Florida Clinical Trials Group

Tamarac, Florida, United States

University Cancer & Blood Center, LLC

Athens, Georgia, United States

Local Institution - 0412

Augusta, Georgia, United States

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

Marietta, Georgia, United States

Local Institution - 0423

Urbana, Illinois, United States

Northwest Cancer Centers, P.C.

Dyer, Indiana, United States

Missouri Cancer Associates

Columbia, Missouri, United States

Local Institution - 0224

Laurelton, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Optum Medical Care, PC

Westbury, New York, United States

Local Institution - 0283

Winston-Salem, North Carolina, United States

Local Institution - 0383

Cincinnati, Ohio, United States

Local Institution - 0418

Oklahoma City, Oklahoma, United States

Local Institution - 0288

Lancaster, Pennsylvania, United States

Local Institution - 0028

Pittsburgh, Pennsylvania, United States

WellSpan Oncology Research

York, Pennsylvania, United States

University Of Texas Medical Branch At Galveston

Galveston, Texas, United States

Kelsey-Seybold Clinic Main Campus

Houston, Texas, United States

Texas Oncology - San Antonio

San Antonio, Texas, United States

Local Institution - 0381

San Antonio, Texas, United States

Local Institution - 0337

Richmond, Virginia, United States

Shenandoah Oncology, P.C.

Winchester, Virginia, United States

Local Institution - 0384

Spokane, Washington, United States

Local Institution - 0339

Charleston, West Virginia, United States

HSHS St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, United States

Local Institution - 0421

Marshfield, Wisconsin, United States

Local Institution - 0076

Mar del Plata, Buenos Aires, Argentina

Fundacion Estudios Clinicos

Rosario, Santa Fe Province, Argentina

Sanatorio Plaza

Rosario, Santa Fe Province, Argentina

Local Institution - 0420

San Miguel de Tucumán, Tucumán Province, Argentina

Local Institution - 0058

Buenos Aires, Argentina

Local Institution - 0374

Córdoba, Argentina

Gosford Hospital

Gosford, New South Wales, Australia

Nepean Hospital

Penrith, New South Wales, Australia

Lyell McEwin Hospital

Elizabeth Vale, South Australia, Australia

Local Institution - 0201

Epping, Victoria, Australia

Grampians Health

Mount Waverley, Victoria, Australia

Joondalup Health Campus

Joondalup, Western Australia, Australia

Kepler Universitaetsklinikum

Linz, Upper Austria, Austria

Local Institution - 0196

Feldkirch, Austria

Universitätsklinikum St. Pölten

Sankt Pölten, Austria

ZAS Augustinus

Wilrijk, Antwerpen, Belgium

Local Institution - 0333

Auderghem, Bruxelles-Capitale, Région de, Belgium

Local Institution - 0109

Leuven, Vlaams-Brabant, Belgium

Algemeen Ziekenhuis klina

Brasschaat, Belgium

Local Institution - 0148

Fortaleza, Ceará, Brazil

Local Institution - 0066

Natal/RN, Rio Grande do Norte, Brazil

Local Institution - 0245

Porto Alegre, Rio Grande do Sul, Brazil

Fundação Pio XII - Hospital de Câncer de Barretos

Barretos, São Paulo, Brazil

Local Institution - 0375

São Paulo, São Paulo, Brazil

Local Institution - 0090

Taubaté, São Paulo, Brazil

Centro Paulista de Oncologia Clínica

São Paulo, Brazil

Complex Oncology Center - Ruse EOOD

Rousse, Bulgaria

Local Institution - 0326

Sofia, Bulgaria

Local Institution - 0047

Sofia, Bulgaria

Local Institution - 0325

Sofia, Bulgaria

Local Institution - 0411

Prince George, British Columbia, Canada

Local Institution - 0002

Halifax, Nova Scotia, Canada

Local Institution - 0414

Oshawa, Ontario, Canada

Local Institution - 0178

Ottawa, Ontario, Canada

Local Institution - 0156

Toronto, Ontario, Canada

Local Institution - 0361

Antofagasta, AN, Chile

Local Institution - 0302

Las Condes, Arica y Parinacota Region, Chile

Local Institution - 0199

Santiago, Santiago Metropolitan, Chile

Local Institution - 0293

Concepción, Chile

Local Institution - 0150

Independencia, Chile

Local Institution - 0175

Beijing, Beijing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Local Institution - 0141

Xiamen, Fujian, China

Local Institution - 0327

Zhangzhou, Fujian, China

Local Institution - 0312

Guangzhou, Guangdong, China

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, China

Guangxi Medical University Affiliated Tumor Hospital

Nanning, Guangxi, China

Local Institution - 0317

Harbin, Heilongjiang, China

Local Institution - 0046

Zhengzhou, Henan, China

Local Institution - 0004

Changsha, Hunan, China

Local Institution - 0117

Nanjing, Jiangsu, China

Local Institution - 0316

Nanjing, Jiangsu, China

Local Institution - 0023

Nanchang, Jiangxi, China

Local Institution - 0177

Shenyang, Liaoning, China

Local Institution - 0014

Xi'an, Shaanxi, China

Shandong Cancer Hospital

Jinan, Shandong, China

Local Institution - 0123

Linyi, Shandong, China

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Local Institution - 0212

Shanghai Shi, Shanghai Municipality, China

Local Institution - 0246

Chengdu, Sichuan, China

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Local Institution - 0089

Hangzhou, Zhejiang, China

Local Institution - 0113

Beijing, China

Local Institution - 0122

Shanghai Shi, China

Local Institution - 0310

Rionegro, Antioquia, Colombia

Local Institution - 0328

Barranquilla, Atlántico, Colombia

Local Institution - 0218

Bogotá, Colombia

Local Institution - 0307

Medellín, Colombia

Local Institution - 0092

Ostrava, Moravian-Silesian, Czechia

Local Institution - 0129

Pilsen, Plzeň Region, Czechia

Local Institution - 0243

Hradec Králové, Czechia

Local Institution - 0236

Olomouc, Czechia

Kuopion Yliopistollinen Sairaala

Kuopio, Northern Savonia, Finland

Tampereen yliopistollinen sairaala

Tampere, Finland

Vaasan Keskussairaala

Vaasa, Finland

Local Institution - 0398

Nice, Alpes-Maritimes, France

CHU Bordeaux Haut-Leveque

Pessac, Aquitaine, France

Local Institution - 0162

Lille, Hauts-de-France, France

Local Institution - 0239

Montpellier, Hérault, France

Local Institution - 0144

La Tronche, Isère, France

Local Institution - 0057

Saint-Herblain, Loire-Atlantique, France

Local Institution - 0059

Toulouse, Midi-Pyrénées, France

Local Institution - 0397

Dijon, France

Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren

Limoges, France

Local Institution - 0151

Marseille, France

Hopitaux Universitaires Paris Centre-Hopital Cochin

Paris, France

Centre Hospitalier de Cornouaille Quimper - Concarneau

Quimper, France

Institut Jean Godinot

Reims, France

Local Institution - 0207

Paris, Île-de-France Region, France

Fachkliniken Wangen

Wangen, Baden-Wurttemberg, Germany

VK&K Studien GbR

Landshut, Bavaria, Germany

RoMed Klinikum Rosenheim

Rosenheim, Bavaria, Germany

Local Institution - 0357

Kaiserslautern, Deutschland, Germany

Gemeinschaftspraxis für Hämatologie und Onkologie

Langen, Hesse, Germany

Local Institution - 0433

Wiesbaden, Hesse, Germany

Local Institution - 0432

Cologne, North Rhine-Westphalia, Germany

Local Institution - 0428

Dortmund, North Rhine-Westphalia, Germany

Local Institution - 0187

Solingen, North Rhine-Westphalia, Germany

Local Institution - 0172

Kiel, Schleswig-Holstein, Germany

HELIOS Klinikum Erfurt

Erfurt, Thuringia, Germany

Local Institution - 0231

Berlin, Germany

Local Institution - 0158

Braunschweig, Germany

Local Institution - 0073

Essen, Germany

Local Institution - 0103

Gera, Germany

Local Institution - 0071

Göttingen, Germany

Local Institution - 0083

Sindelfingen, Germany

Local Institution - 0240

Budapest, Hungary

Local Institution - 0012

Farkasgyepű, Hungary

Local Institution - 0244

Mátraháza, Hungary

Local Institution - 0241

Szolnok, Hungary

Local Institution - 0303

Eluru, Andhra Pradesh, India

Local Institution - 0319

Visakhapatnam, Andhra Pradesh, India

Local Institution - 0427

Goraj, Gujarat, India

Local Institution - 0219

Mumbai, Maharashtra, India

Local Institution - 0015

Mumbai, Maharashtra, India

Local Institution - 0008

Nagpur, Maharashtra, India

Local Institution - 0125

Dwarka, National Capital Territory of Delhi, India

Local Institution - 0020

Hyderabad, Telangana, India

Local Institution - 0078

Delhi, India

Local Institution - 0036

Pune, India

AOU di Ferrara Arcispedale S. Anna

Ferrara (Cona), Emilia-Romagna, Italy

Cro-Irccs

Aviano, Friuli Venezia Giulia, Italy

Local Institution - 0279

Catania, Sicily, Italy

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

Candiolo, Torino, Italy

Local Institution - 0111

Genova, Italy

Local Institution - 0033

Milan, Italy

Local Institution - 0040

Naples, Italy

Azienda Ospedaliero Universitaria Maggiore della Carità

Novara, Italy

Toyohashi Municipal Hospital

Toyohashi, Aichi-ken, Japan

Funabashi Municipal Medical Center

Funabashi, Chiba, Japan

Local Institution - 0256

Tōon, Ehime, Japan

Sapporo Minami-Sanjo Hospital

Sapporo, Hokkaido, Japan

Hyogo Medical University Hospital

Nishinomiya, Hyōgo, Japan

Ishikawa Prefectural Central Hospital

Kanazawa, Ishikawa-ken, Japan

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Kanagawa cancer center

Yokohama, Kanagawa, Japan

Local Institution - 0257

Sendai, Miyagi, Japan

Sendai Kousei Hospital

Sendai, Miyagi, Japan

Kindai University Hospital

Sakai, Osaka, Japan

Saitama Medical University International Medical Center

Hidaka, Saitama, Japan

Dokkyo Medical University Saitama Medical Center

Koshigaya, Saitama, Japan

Aomori Prefectural Central Hospital

Aomori, Japan

Hamamatsu University Hospital

Hamamatsu, Japan

Local Institution - 0252

Hirakata-shi, Japan

Hiroshima Prefectural Hospital

Hiroshima, Japan

Saiseikai Kumamoto Hospital

Kumamoto, Japan

Local Institution - 0275

George Town, Pulau Pinang, Malaysia

Local Institution - 0271

Kuching, Sarawak, Malaysia

Local Institution - 0277

Kuala Lumpur, Malaysia

Local Institution - 0070

Zapopan, Jalisco, Mexico

Local Institution - 0075

Mexico City, Mexico City, Mexico

Local Institution - 0386

Monterrey, Nuevo León, Mexico

Local Institution - 0385

Mexico City, Mexico

Local Institution - 0097

Oaxaca City, Mexico

Local Institution - 0124

Querétaro, Mexico

Local Institution - 0110

Nijmegen, Gelderland, Netherlands

Local Institution - 0286

Breda, North Brabant, Netherlands

Local Institution - 0100

's-Hertogenbosch, Netherlands

Meander Medisch Centrum

Amersfoort, Netherlands

Local Institution - 0261

Deventer, Netherlands

ETZ Elisabeth

Tilburg, Netherlands

Østfold Hopsital, Kalnes

Grålum, Akershus, Norway

Drammen Sykehus, Vestre Viken HF

Drammen, Buskerud, Norway

Local Institution - 0121

San Borja, Lima region, Peru

Local Institution - 0155

Lima, Peru

Local Institution - 0296

Lima, Peru

Local Institution - 0041

Opole, Opole Voivodeship, Poland

Local Institution - 0227

Przemyśl, Podkarpackie Voivodeship, Poland

Local Institution - 0105

Katowice, Poland

Local Institution - 0329

Katowice, Poland

Local Institution - 0186

Lodz, Poland

Unidade Local de Saúde de Braga

Braga, Portugal

Unidade Local de Saúde Santa Maria - Lisboa

Lisbon, Portugal

Centrul de Diagnostic si Tratament Provita

Bucharest, Bucharest, Romania

SC Radiotherapy Center Cluj SRL

Florești, Cluj, Romania

Centrul de Oncologie "Sfântul Nectarie"

Craiova, Dolj, Romania

Oncohelp Medical Center

Timișoara, Timiș County, Romania

Local Institution - 0191

Baloteşti, Romania

Spitalul Clinic Colțea

Bucharest, Romania

Local Institution - 0136

Bucharest, Romania

Institutul Oncologic Cluj

Cluj-Napoca, Romania

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

Iași, Romania

Institutul Regional de Oncologie

Iași, Romania

Local Institution - 0267

Singapore, Singapore

Local Institution - 0269

Singapore, Singapore

Pusan National University Yangsan Hospital

Busan, Kyǒngsangnam-do, South Korea

Konkuk University Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Kyungpook National University Chilgok Hospital

Deagu, Taegu-Kwangyǒkshi, South Korea

Chungnam national university hospital

Junggu, Taejǒn-Kwangyǒkshi, South Korea

Parc de Salut Mar - Hospital del Mar

Barcelona, Barcelona [Barcelona], Spain

OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces

Barakaldo, Basque Country, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalunya [Cataluña], Spain

Hospital Universitario de Jaen

Jaén, Spain

Local Institution - 0266

Madrid, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Hospital General Universitario Morales Meseguer

Murcia, Spain

Local Institution - 0039

Stockholm, Stockholm County, Sweden

Local Institution - 0010

Gävle, Sweden

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Local Institution - 0053

Sankt Gallen, Switzerland

Onkologiezentrum Thun-Berner Oberland Spital Sts Ag

Thun, Switzerland

Local Institution - 0262

Villars-sur-Glâne, Switzerland

Chang Gung Memorial Hospital at Kaohsiung

Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan

Local Institution - 0387

Kaohsiung City, Taiwan

Far Eastern Memorial Hospital

New Taipei City, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, Taiwan

Local Institution - 0272

Bangkok, Thailand

Local Institution - 0405

Chiang Mai, Thailand

Local Institution - 0273

Khon Kaen, Thailand

Local Institution - 0274

Songkhla, Thailand

Local Institution - 0242

Adana, Turkey (Türkiye)

Local Institution - 0091

Adana, Turkey (Türkiye)

Local Institution - 0415

Ankara, Turkey (Türkiye)

Local Institution - 0118

Antalya, Turkey (Türkiye)

Local Institution - 0235

Cordaleo, Turkey (Türkiye)

Local Institution - 0238

Çankaya, Turkey (Türkiye)

Local Institution - 0107

Istanbul, Turkey (Türkiye)

Local Institution - 0017

Istanbul, Turkey (Türkiye)

Local Institution - 0133

Istanbul, Turkey (Türkiye)

Local Institution - 0367

Istanbul, Turkey (Türkiye)

Local Institution - 0364

Izmir, Turkey (Türkiye)

Aberdeen Royal Infirmary

Aberdeen, Aberdeenshire, United Kingdom

Local Institution - 0112

Middlesbrough, Cleveland, United Kingdom

Local Institution - 0426

Norwich, East, United Kingdom

The Royal Marsden NHS Foundation Trust

Sutton, South East, United Kingdom

Addenbrooke's Hospital

Cambridge, United Kingdom

Velindre Cancer Centre

Cardiff, United Kingdom

The Royal Surrey County Hospital NHS Foundation Trust

Guildford, United Kingdom

Royal Marsden Hospital (Chelsea)

London, United Kingdom

Royal Wolverhampton Nhs Trust

Wolverhampton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07361510

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