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RECRUITING
NCT07361510
PHASE3

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)

Sponsor: Bristol-Myers Squibb

View on ClinicalTrials.gov

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%.

Official title: 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%.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

750

Start Date

2026-03-12

Completion Date

2031-10-14

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

DRUG

Pumitamig

Specified dose on specified days

DRUG

Pembrolizumab

Specified dose on specified days

Locations (267)

Local Institution - 0348

Daphne, Alabama, United States

Local Institution - 0391

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 - 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

BRP- Hialeah Hospital

Hialeah, Florida, United States

Local Institution - 0406

Pompano Beach, Florida, United States

Local Institution - 0396

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 - 0289

Lexington, Kentucky, United States

Missouri Cancer Associates

Columbia, Missouri, United States

Local Institution - 0224

Laurelton, New York, United States

Local Institution - 0026

New York, New York, United States

Local Institution - 0214

Westbury, New York, United States

Local Institution - 0300

Pinehurst, North Carolina, 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

Local Institution - 0344

York, Pennsylvania, United States

Local Institution - 0376

Galveston, Texas, United States

Local Institution - 0353

Houston, Texas, United States

Local Institution - 0409

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

Local Institution - 0380

Green Bay, Wisconsin, United States

Local Institution - 0076

Mar del Plata, Buenos Aires, Argentina

Local Institution - 0229

Rosario, Santa Fe Province, Argentina

Local Institution - 0362

Rosario, Santa Fe Province, Argentina

Local Institution - 0058

Buenos Aires, Argentina

Local Institution - 0374

Córdoba, Argentina

Local Institution - 0360

Kanwal, New South Wales, Australia

Local Institution - 0176

Penrith, New South Wales, Australia

Local Institution - 0154

Elizabeth Vale, South Australia, Australia

Local Institution - 0221

Ballarat, Victoria, Australia

Local Institution - 0201

Epping, Victoria, Australia

Local Institution - 0038

Joondalup, Western Australia, Australia

Local Institution - 0064

Linz, Upper Austria, Austria

Local Institution - 0196

Feldkirch, Austria

Local Institution - 0095

Sankt Pölten, Austria

Local Institution - 0345

Brasschaat, Antwerpen, Belgium

Local Institution - 0333

Auderghem, Bruxelles-Capitale, Région de, Belgium

Local Institution - 0109

Leuven, Vlaams-Brabant, Belgium

Local Institution - 0188

Edegem, 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

Local Institution - 0085

Barretos, São Paulo, Brazil

Local Institution - 0375

São Paulo, São Paulo, Brazil

Local Institution - 0090

Taubaté, São Paulo, Brazil

Local Institution - 0163

São Paulo, Brazil

Local Institution - 0202

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 - 0413

Fredericton, New Brunswick, 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 - 0222

Santiago, Santiago Metropolitan, 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

Local Institution - 0167

Fuzhou, Fujian, China

Local Institution - 0141

Xiamen, Fujian, China

Local Institution - 0327

Zhangzhou, Fujian, China

Local Institution - 0312

Guangzhou, Guangdong, China

Local Institution - 0210

Shantou, Guangdong, China

Local Institution - 0255

Nanning, Guangxi, China

Local Institution - 0317

Harbin, Heilongjiang, 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

Local Institution - 0359

Jinan, Shandong, China

Local Institution - 0123

Linyi, Shandong, China

Local Institution - 0185

Shanghai, Shanghai Municipality, China

Local Institution - 0212

Shanghai Shi, Shanghai Municipality, China

Local Institution - 0246

Chengdu, Sichuan, China

Local Institution - 0183

Hangzhou, Zhejiang, China

Local Institution - 0089

Hangzhou, Zhejiang, China

Local Institution - 0113

Beijing, China

Local Institution - 0122

Shanghai Shi, China

Local Institution - 0046

Zhengzhou, 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

Local Institution - 0060

Kuopio, Northern Savonia, Finland

Local Institution - 0171

Tampere, Finland

Local Institution - 0126

Vaasa, Finland

Local Institution - 0398

Nice, Alpes-Maritimes, France

Local Institution - 0130

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

Local Institution - 0054

Limoges, France

Local Institution - 0151

Marseille, France

Local Institution - 0206

Paris, France

Local Institution - 0390

Quimper, France

Local Institution - 0400

Reims, France

Local Institution - 0207

Paris, Île-de-France Region, France

Local Institution - 0072

Wangen, Baden-Wurttemberg, Germany

Local Institution - 0270

Landshut, Bavaria, Germany

Local Institution - 0024

Rosenheim, Bavaria, Germany

Local Institution - 0187

Solingen, North Rhine-Westphalia, Germany

Local Institution - 0172

Kiel, Schleswig-Holstein, Germany

Local Institution - 0231

Berlin, Germany

Local Institution - 0158

Braunschweig, Germany

Local Institution - 0157

Erfurt, Germany

Local Institution - 0073

Essen, Germany

Local Institution - 0103

Gera, Germany

Local Institution - 0071

Göttingen, Germany

Local Institution - 0357

Kaiserslautern, Germany

Local Institution - 0264

Münster, Germany

Local Institution - 0083

Sindelfingen, Germany

Local Institution - 0240

Budapest, Hungary

Local Institution - 0234

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 - 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

Local Institution - 0281

Ferrara (Cona), Emilia-Romagna, Italy

Local Institution - 0174

Novara, Piedmont, Italy

Local Institution - 0279

Catania, Sicily, Italy

Local Institution - 0194

Aviano (PN), Italy

Local Institution - 0032

Candiolo, Italy

Local Institution - 0111

Genova, Italy

Local Institution - 0033

Milan, Italy

Local Institution - 0040

Naples, Italy

Local Institution - 0055

Toyohashi, Aichi-ken, Japan

Local Institution - 0363

Aomori, Aomori, Japan

Local Institution - 0258

Funabashi, Chiba, Japan

Local Institution - 0256

Tōon, Ehime, Japan

Local Institution - 0417

Sapporo, Hokkaido, Japan

Local Institution - 0251

Nishinomiya-shi, Hyōgo, Japan

Local Institution - 0056

Kanazawa, Ishikawa-ken, Japan

Local Institution - 0259

Kamakura, Kanagawa, Japan

Local Institution - 0248

Kumamoto, Kumamoto, Japan

Local Institution - 0254

Sendai, Miyagi, Japan

Local Institution - 0257

Sendai, Miyagi, Japan

Local Institution - 0250

Osakasayama-shi, Osaka, Japan

Local Institution - 0247

Koshigaya, Saitama, Japan

Local Institution - 0166

Hidaka, Saitama-Pref, Japan

Local Institution - 0253

Hamamatsu, Japan

Local Institution - 0252

Hirakata-shi, Japan

Local Institution - 0341

Hiroshima, Japan

Local Institution - 0249

Yokohama, 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

Local Institution - 0161

Amersfoort, Netherlands

Local Institution - 0261

Deventer, Netherlands

Local Institution - 0094

Tilburg, Netherlands

Local Institution - 0164

Grålum, Akershus, Norway

Local Institution - 0050

Drammen, Buskerud, Norway

Local Institution - 0121

San Borja, Lima region, Peru

Local Institution - 0155

Lima, Peru

Local Institution - 0296

Lima, Peru

Local Institution - 0227

Przemyśl, Podkarpackie Voivodeship, Poland

Local Institution - 0329

Katowice, Poland

Local Institution - 0186

Lodz, Poland

Local Institution - 0041

Opole, Poland

Local Institution - 0105

Warsaw, Poland

Local Institution - 0294

Braga, Portugal

Local Institution - 0278

Lisbon, Portugal

Local Institution - 0191

Baloteşti, Ilfov, Romania

Local Institution - 0044

Bucharest, Romania

Local Institution - 0049

Bucharest, Romania

Local Institution - 0136

Bucharest, Romania

Local Institution - 0209

Cluj-Napoca, Romania

Local Institution - 0084

Craiova, Romania

Local Institution - 0132

Floresti/ Cluj, Romania

Local Institution - 0127

Iași, Romania

Local Institution - 0068

Iași, Romania

Local Institution - 0267

Singapore, Singapore

Local Institution - 0269

Singapore, Singapore

Local Institution - 0343

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Local Institution - 0336

Deagu, Taegu-Kwangyǒkshi, South Korea

Local Institution - 0335

Junggu, Taejǒn-Kwangyǒkshi, South Korea

Local Institution - 0342

Yangsan, South Korea

Local Institution - 0181

Málaga, Málaga, Spain

Local Institution - 0074

Barakaldo, Spain

Local Institution - 0009

Barcelona, Spain

Local Institution - 0142

Barcelona, Spain

Local Institution - 0099

Jaén, Spain

Local Institution - 0266

Madrid, Spain

Local Institution - 0021

Madrid, Spain

Local Institution - 0179

Madrid, Spain

Local Institution - 0263

Murcia, Spain

Local Institution - 0039

Stockholm, Stockholm County, Sweden

Local Institution - 0010

Gävle, Sweden

Local Institution - 0399

Lausanne, Switzerland

Local Institution - 0053

Sankt Gallen, Switzerland

Local Institution - 0019

Thun, Switzerland

Local Institution - 0262

Villars-sur-Glâne, Switzerland

Local Institution - 0389

Kaohsuing City, Kaohsiung, Taiwan

Local Institution - 0388

Taoyuan, Taoyuan, Taiwan

Local Institution - 0203

Chiayi City, Taiwan

Local Institution - 0387

Kaohsiung City, Taiwan

Local Institution - 0035

New Taipei City, 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)

Local Institution - 0365

Aberdeen, Aberdeenshire, United Kingdom

Local Institution - 0112

Middlesbrough, Cleveland, United Kingdom

Local Institution - 0410

Sutton, South East, United Kingdom

Local Institution - 0114

Cambridge, United Kingdom

Local Institution - 0182

Cardiff, United Kingdom

Local Institution - 0007

Guildford, United Kingdom

Local Institution - 0087

London, United Kingdom

Local Institution - 0371

Wolverhampton, United Kingdom