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RECRUITING
NCT07361497
PHASE3

A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201)

Sponsor: Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)

Official title: ROSETTA Lung-201: A Randomized, Multicenter, Open-label Phase 3 Study of Pumitamig Monotherapy Compared to Durvalumab in Participants With Unresectable Stage III NSCLC Without Progression After Platinum-based Concurrent Chemoradiation Therapy.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

850

Start Date

2026-03-16

Completion Date

2033-12-31

Last Updated

2026-04-06

Healthy Volunteers

No

Interventions

DRUG

Pumitamig

Specified dose on specified days

DRUG

Durvalumab

Specified dose on specified days

Locations (255)

Southern Cancer Center Pc

Daphne, Alabama, United States

Local Institution - 0780

Chandler, Arizona, United States

Local Institution - 0585

Golden, Colorado, United States

Medical Oncology Hematology Consultants, PA

Newark, Delaware, United States

Local Institution - 0711

Ocala, Florida, United States

Local Institution - 0756

Marietta, Georgia, United States

Local Institution - 0398

Chicago, Illinois, United States

Local Institution - 0850

Evanston, Illinois, United States

Illinois Cancer Care

Peoria, Illinois, United States

Local Institution - 0317

Fort Wayne, Indiana, United States

Local Institution - 0656

Lexington, Kentucky, United States

Local Institution - 0603

Boston, Massachusetts, United States

Local Institution - 0419

Flint, Michigan, United States

Minnesota Oncology Hematology

Maple Grove, Minnesota, United States

Local Institution - 0142

Saint Paul, Minnesota, United States

Missouri Cancer Associates

Columbia, Missouri, United States

Local Institution - 0606

New York, New York, United States

Local Institution - 0339

Westbury, New York, United States

Local Institution - 0909

Westbury, New York, United States

Local Institution - 0493

Winston-Salem, North Carolina, United States

Local Institution - 0923

Akron, Ohio, United States

Local Institution - 0412

Cincinnati, Ohio, United States

Local Institution - 0359

Cleveland, Ohio, United States

Local Institution - 0597

Cleveland, Ohio, United States

Local Institution - 0924

Mayfield Heights, Ohio, United States

Oncology Associates Of Oregon, Pc

Eugene, Oregon, United States

Northwest Cancer Specialists, P.C.

Happy Valley, Oregon, United States

Local Institution - 0480

Nashville, Tennessee, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Texas Oncology - Amarillo Cancer Center

Amarillo, Texas, United States

Texas Oncology-Austin Central

Austin, Texas, United States

Texas Oncology

Denton, Texas, United States

Local Institution - 0811

Fort Worth, Texas, United States

Local Institution - 0596

Houston, Texas, United States

Texas Oncology - San Antonio Medical Center

San Antonio, Texas, United States

Texas Oncology - Northeast Texas

Tyler, Texas, United States

Blue Ridge Cancer Care

Christiansburg, Virginia, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Local Institution - 0093

Buenas Aires, Buenos Aires, Argentina

Local Institution - 0082

Mar del Plata, Buenos Aires, Argentina

Local Institution - 0097

Rosario, Santa Fe Province, Argentina

Local Institution - 0094

Buenos Aires, Argentina

Local Institution - 0078

Buenos Aires, Argentina

Local Institution - 0761

Buenos Aires, Argentina

Local Institution - 0608

Córdoba, Argentina

Local Institution - 0313

Córdoba, Argentina

Local Institution - 0456

Gosford, New South Wales, Australia

Local Institution - 0446

Penrith, New South Wales, Australia

Local Institution - 0448

Elizabeth Vale, South Australia, Australia

Local Institution - 0442

Ballarat, Victoria, Australia

Local Institution - 0458

Epping, Victoria, Australia

Local Institution - 0476

Joondalup, Western Australia, Australia

Local Institution - 0451

Wentworthville, Australia

Local Institution - 0190

Innsbruck, Austria

Local Institution - 0192

Linz, Austria

Local Institution - 0207

Vienna, Austria

Local Institution - 0906

Brasschaat, Antwerpen, Belgium

Local Institution - 0122

Anderlecht, Bruxelles-Capitale, Région de, Belgium

Local Institution - 0111

Charleroi, Hainaut, Belgium

Local Institution - 0714

Genk, Limburg, Belgium

Local Institution - 0120

Ghent, Oost-Vlaanderen, Belgium

Local Institution - 0117

Sint-Niklaas, Oost-Vlaanderen, Belgium

Local Institution - 0116

Leuven, Vlaams-Brabant, Belgium

Local Institution - 0615

Teresina, Piauí, Brazil

Local Institution - 0498

Natal/RN, Rio Grande do Norte, Brazil

Local Institution - 0619

Porto Alegre, Rio Grande do Sul, Brazil

Local Institution - 0535

Barretos, São Paulo, Brazil

Local Institution - 0538

São José do Rio Preto, São Paulo, Brazil

Local Institution - 0912

São Paulo, Brazil

Local Institution - 0736

Haskovo, Bulgaria

Local Institution - 0551

Rousse, Bulgaria

Local Institution - 0826

Sofia, Bulgaria

Local Institution - 0732

Sofia, Bulgaria

Local Institution - 0838

Sofia, Bulgaria

Local Institution - 0337

Ottawa, Ontario, Canada

Local Institution - 0644

Montreal, Quebec, Canada

Local Institution - 0682

Québec, Canada

Local Institution - 0910

Antofagasta, AN, Chile

Local Institution - 0855

Las Condes, Arica y Parinacota Region, Chile

Local Institution - 0328

Viña del Mar, Región de Valparaíso, Chile

Local Institution - 0478

Santiago, Santiago Metropolitan, Chile

Local Institution - 0037

Santiago, Santiago Metropolitan, Chile

Local Institution - 0077

Santiago, Santiago Metropolitan, Chile

Local Institution - 0754

Beijing, Beijing Municipality, China

Local Institution - 0308

Chongqing, Chongqing Municipality, China

Local Institution - 0245

Fuzhou, Fujian, China

Local Institution - 0298

Shantou, Guangdong, China

Local Institution - 0919

Shenzhen, Guangdong, China

Local Institution - 0249

Zhengzhou, Henan, China

Local Institution - 0911

Jingzhou, Hubei, China

Local Institution - 0921

Wuhan, Hubei, China

Local Institution - 0813

Wuhan, Hubei, China

Local Institution - 0489

Changsha, Hunan, China

Local Institution - 0918

Suzhou, Jiangsu, China

Local Institution - 0254

Nanchang, Jiangxi, China

Local Institution - 0242

Shenyang, Liaoning, China

Local Institution - 0527

Xi'an, Shaanxi, China

Local Institution - 0528

Jinan, Shandong, China

Local Institution - 0297

Jinan, Shandong, China

Local Institution - 0248

Shanghai, Shanghai Municipality, China

Local Institution - 0542

Taiyuan, Shanxi, China

Local Institution - 0440

Chengdu, Sichuan, China

Local Institution - 0835

Chengdu, Sichuan, China

Local Institution - 0719

Hangzhou, Zhejiang, China

Local Institution - 0253

Linhai, Zhejiang, China

Local Institution - 0561

Guangzhou, China

Local Institution - 0301

Hangzhou, China

Local Institution - 0537

Shanghai Shi, China

Local Institution - 0564

Xi'an, China

Local Institution - 0029

Bordeaux, Aquitaine, France

Local Institution - 0130

Lyon Cedex08, Auvergne-Rhône-Alpes, France

Local Institution - 0129

Dijon, Côte-d'Or, France

Local Institution - 0716

Lille, Hauts-de-France, France

Local Institution - 0028

Montpellier, Hérault, France

Local Institution - 0127

Saint-Herblain, Loire-Atlantique, France

Local Institution - 0023

Toulouse, Midi-Pyrénées, France

Local Institution - 0689

Villejuif, Val-de-Marne, France

Local Institution - 0025

Limoges, France

Local Institution - 0024

Marseille, France

Local Institution - 0026

Paris, France

Local Institution - 0021

Paris, France

Local Institution - 0739

Augsburg, Bavaria, Germany

Local Institution - 0265

Koblenz, Rhineland-Palatinate, Germany

Local Institution - 0174

Ludwigshafen am Rhein, Rhineland-Palatinate, Germany

Local Institution - 0172

Kiel, Schleswig-Holstein, Germany

Local Institution - 0182

Jena, Thuringia, Germany

Local Institution - 0217

Berlin, Germany

Local Institution - 0215

Berlin, Germany

Local Institution - 0169

Göttingen, Germany

Local Institution - 0178

Gröbenzell, Germany

Local Institution - 0199

Haile, Germany

Local Institution - 0299

Hamburg, Germany

Local Institution - 0186

Immenhausen, Germany

Local Institution - 0187

Regensburg, Germany

Local Institution - 0416

Thessaloniki, Thessaloníki, Greece

Local Institution - 0321

Larissa, Thessalía, Greece

Local Institution - 0391

Athens, Greece

Local Institution - 0323

Athens, Greece

Local Institution - 0324

Athens, Greece

Local Institution - 0697

Thessaloniki, Greece

Local Institution - 0457

Tuenmen, NT, Hong Kong

Local Institution - 0193

Hksar, Hong Kong

Local Institution - 0764

Shatin, Hong Kong

Local Institution - 0139

Kecskemét, Bács-Kiskun county, Hungary

Local Institution - 0787

Szolnok, Jász-Nagykun-Szolnok, Hungary

Local Institution - 0138

Budapest, Hungary

Local Institution - 0776

Farkasgyepű, Hungary

Local Institution - 0696

Törökbálint, Hungary

Local Institution - 0840

Eluru, Andhra Pradesh, India

Local Institution - 0548

Pūlakkōd, Kerala, India

Local Institution - 0864

Aurangabad, Maharashtra, India

Local Institution - 0660

Mumbai, Maharashtra, India

Local Institution - 0663

Mumbai, Maharashtra, India

Local Institution - 0661

Nagpur, Maharashtra, India

Local Institution - 0664

Dwarka, National Capital Territory of Delhi, India

Local Institution - 0856

New Delhi, National Capital Territory of Delhi, India

Local Institution - 0657

Hyderabad, Telangana, India

Local Institution - 0547

Delhi, India

Local Institution - 0659

Pune, India

Local Institution - 0276

Cork, Ireland

Local Institution - 0270

Dublin, Ireland

Local Institution - 0070

Dublin, Ireland

Local Institution - 0304

Orbassano, Piedmont, Italy

Local Institution - 0669

Rome, Roma, Italy

Local Institution - 0269

Aviano (PN), Italy

Local Institution - 0668

Milan, Italy

Local Institution - 0667

Milan, Italy

Local Institution - 0275

Naples, Italy

Local Institution - 0390

Parma, Italy

Local Institution - 0670

Ravenna, Italy

Local Institution - 0014

Nagoya, Aichi-ken, Japan

Local Institution - 0701

Kobe, Hyōgo, Japan

Local Institution - 0154

Nishinomiya-shi, Hyōgo, Japan

Local Institution - 0001

Sendai, Miyagi, Japan

Local Institution - 0907

Okayama, Okayama-ken, Japan

Local Institution - 0002

Osakasayama-shi, Osaka, Japan

Local Institution - 0149

Hidaka, Saitama-Pref, Japan

Local Institution - 0018

Bunkyo Ku, Tokyo, Japan

Local Institution - 0158

Hamamatsu, Japan

Local Institution - 0016

Hirakata-shi, Japan

Local Institution - 0009

Minami-Ku, Fukuoka, Japan

Local Institution - 0157

Sagamihara, Japan

Local Institution - 0759

Sendai, Japan

Local Institution - 0008

Yokohama, Japan

Local Institution - 0772

Saltillo, Coahuila, Mexico

Local Institution - 0815

Tijuana, Estado de Baja California, Mexico

Local Institution - 0699

Zapopan, Jalisco, Mexico

Local Institution - 0330

Monterrey, Nuevo León, Mexico

Local Institution - 0914

Puebla City, Mexico

Local Institution - 0349

Querétaro, Mexico

Local Institution - 0243

Nijmegen, Gelderland, Netherlands

Local Institution - 0095

Breda, North Brabant, Netherlands

Local Institution - 0091

Amsterdam, North Holland, Netherlands

Local Institution - 0087

Zwolle, Overijssel, Netherlands

Local Institution - 0089

Groningen, Netherlands

Local Institution - 0092

Tilburg, Netherlands

Local Institution - 0473

Lublin, Lublin Voivodeship, Poland

Local Institution - 0556

Przemyśl, Podkarpackie Voivodeship, Poland

Local Institution - 0681

Katowice, Silesian Voivodeship, Poland

Local Institution - 0680

Opole, Poland

Local Institution - 0219

Bucharest, București, Romania

Local Institution - 0046

Bucharest, Romania

Local Institution - 0168

Cluj-Napoca, Romania

Local Institution - 0045

Craiova, Romania

Local Institution - 0058

Floresti/ Cluj, Romania

Local Institution - 0184

Iași, Romania

Local Institution - 0164

Iași, Romania

Local Institution - 0650

Singapore, Central Singapore, Singapore

Local Institution - 0647

Singapore, Singapore

Local Institution - 0151

Seongnam, Kyǒnggi-do, South Korea

Local Institution - 0055

Seoul, Seoul Teugbyeolsi, South Korea

Local Institution - 0035

Seoul, Seoul Teugbyeolsi, South Korea

Local Institution - 0064

Seoul, Seoul-teukbyeolsi, South Korea

Local Institution - 0052

Cheongju-si, South Korea

Local Institution - 0063

Seoul, South Korea

Local Institution - 0041

L'Hospitalet Del Llobregat, Barcelona [Barcelona], Spain

Local Institution - 0086

Barakaldo, Spain

Local Institution - 0043

Barcelona, Spain

Local Institution - 0042

Barcelona, Spain

Local Institution - 0049

Madrid, Spain

Local Institution - 0570

Málaga, Spain

Local Institution - 0061

Seville, Spain

Local Institution - 0066

Valencia, Spain

Local Institution - 0044

Zaragoza, Spain

Local Institution - 0033

Gävle, Gävleborgs Län [se-21], Sweden

Local Institution - 0032

Solna, Stockholms Län [se-01], Sweden

Local Institution - 0034

Uppsala, Sweden

Local Institution - 0222

Basel, Switzerland

Local Institution - 0166

Bellinzona, Switzerland

Local Institution - 0738

Münsterlingen, Switzerland

Local Institution - 0165

Sankt Gallen, Switzerland

Local Institution - 0734

Zhubei, Hsinchu, Taiwan

Local Institution - 0735

Chiayi City, Taiwan

Local Institution - 0726

Taipei, Taiwan

Local Institution - 0729

Taipei, Taiwan

Local Institution - 0733

Bangkok, Thailand

Local Institution - 0917

Chiang Mai, Thailand

Local Institution - 0160

Khon Kaen, Thailand

Local Institution - 0728

Songkhla, Thailand

Local Institution - 0099

Adana, Turkey (Türkiye)

Local Institution - 0113

Adana, Turkey (Türkiye)

Local Institution - 0198

Antalya, Turkey (Türkiye)

Local Institution - 0109

Çankaya, Turkey (Türkiye)

Local Institution - 0096

Istanbul, Turkey (Türkiye)

Local Institution - 0107

Istanbul, Turkey (Türkiye)

Local Institution - 0239

Manchester, Lancashire, United Kingdom

Local Institution - 0672

Cambridge, United Kingdom

Local Institution - 0289

Cardiff, United Kingdom

Local Institution - 0257

Guildford, United Kingdom

Local Institution - 0693

Leeds, United Kingdom

Local Institution - 0232

Liverpool, United Kingdom

Local Institution - 0296

London, United Kingdom

Local Institution - 0235

London, United Kingdom

Local Institution - 0533

Middlesex, United Kingdom

Local Institution - 0913

Sutton, United Kingdom