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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

2026-08-10

Healthy Volunteers

No

Interventions

DRUG

Pumitamig

Specified dose on specified days

DRUG

Durvalumab

Specified dose on specified days

Locations (258)

Southern Cancer Center Pc

Daphne, Alabama, United States

Local Institution - 0780

Chandler, Arizona, United States

Intermountain Health Cancer Center Lutheran Hospital

Golden, Colorado, United States

Medical Oncology Hematology Consultants, PA

Newark, Delaware, United States

Local Institution - 0711

Ocala, Florida, United States

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

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

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, United States

University of Kentucky Chandler Medical Center

Lexington, Kentucky, United States

Local Institution - 0603

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, 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

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Local Institution - 0339

Westbury, New York, United States

Optum Medical Care, PC

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

SCRI Oncology Partners

Nashville, Tennessee, United States

Tennessee Oncology

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

The Center For Cancer And Blood Disorders

Fort Worth, Texas, United States

The University of Texas-MD Anderson Cancer Center

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

Instituto Argentino De Diagnostico Y Tratamiento IADT

Buenas Aires, Buenos Aires, Argentina

Local Institution - 0082

Mar del Plata, Buenos Aires, Argentina

Hospital Privado Universitario de Córdoba

Córdoba, Córdoba Province, Argentina

Sanatorio Parque Rosario

Rosario, Santa Fe Province, Argentina

Instituto Medico Especializado Alexander Fleming

Buenos Aires, Argentina

Clinica Adventista Belgrano

Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Instituto de Investigaciones Clínicas Córdoba S.A.

Córdoba, Argentina

Gosford Hospital

Gosford, New South Wales, Australia

Nepean Hospital

Penrith, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Lyell McEwin Hospital

Elizabeth Vale, South Australia, Australia

Grampians Health

Ballarat Central, Victoria, Australia

Local Institution - 0458

Epping, Victoria, Australia

Joondalup Health Campus

Joondalup, Western Australia, Australia

Universitätsklinik Innsbruck

Innsbruck, Austria

Local Institution - 0192

Linz, Austria

Local Institution - 0207

Vienna, Austria

Local Institution - 0122

Anderlecht, Bruxelles-Capitale, Région de, Belgium

Local Institution - 0111

Charleroi, Hainaut, Belgium

Ziekenhuis Oost-Limburg, Campus St.-Jan

Genk, Limburg, Belgium

UZ Gent

Ghent, Oost-Vlaanderen, Belgium

VITAZ

Sint-Niklaas, Oost-Vlaanderen, Belgium

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

Algemeen Ziekenhuis klina

Brasschaat, Belgium

Vencer Centro de Pesquisa LTDA

Teresina, Piauí, Brazil

Liga Norte Riograndense Contra o Câncer

Natal, Rio Grande do Norte, Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Fundação Pio XII - Hospital de Câncer de Barretos

Barretos, São Paulo, Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Local Institution - 0912

São Paulo, Brazil

Multiprofile Hospital for Active Treatment - Haskovo AD

Haskovo, Bulgaria

Complex Oncology Center - Ruse EOOD

Rousse, Bulgaria

"Sveta Ekaterina" Hospital

Sofia, Bulgaria

Local Institution - 0732

Sofia, Bulgaria

Diagnostic and Consultative Center Convex

Sofia, Bulgaria

The Ottawa Hospital - General Campus

Ottawa, Ontario, Canada

St. Marys Hospital Center

Montreal, Quebec, Canada

IUCPQ

Québec, Canada

Local Institution - 0910

Antofagasta, AN, Chile

Local Institution - 0855

Las Condes, Arica y Parinacota Region, Chile

Local Institution - 0478

Santiago, Santiago Metropolitan, Chile

Local Institution - 0077

Santiago, Santiago Metropolitan, Chile

Local Institution - 0328

Viña del Mar, Valparaiso, Chile

Local Institution - 0754

Beijing, Beijing Municipality, China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, China

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Local Institution - 0249

Zhengzhou, Henan, China

Jingzhou First People's Hospital

Jingzhou, Hubei, China

The Central Hospital of Wuhan

Wuhan, Hubei, China

Local Institution - 0813

Wuhan, Hubei, China

Local Institution - 0489

Changsha, Hunan, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Local Institution - 0242

Shenyang, Liaoning, China

Local Institution - 0527

Xi'an, Shaanxi, China

Local Institution - 0564

Xi'an, Shaanxi, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Shandong Cancer Hospital

Jinan, Shandong, China

Local Institution - 0248

Shanghai, Shanghai Municipality, China

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

Sichuan Cancer hospital

Chengdu, Sichuan, China

Local Institution - 0440

Chengdu, Sichuan, China

The second Affiliated Hospital of College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Taizhou Hospital Of Zhejiang Province

Linhai, Zhejiang, China

Sun Yat-sen University Cancer Center

Guangzhou, China

Local Institution - 0301

Hangzhou, China

Local Institution - 0537

Shanghai Shi, China

Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

Bordeaux, Aquitaine, France

Centre Leon Berard

Lyon Cedex08, Auvergne-Rhône-Alpes, France

Local Institution - 0129

Dijon, Côte-d'Or, France

Local Institution - 0028

Montpellier, Hérault, France

Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes

Saint-Herblain, Loire-Atlantique, France

CHU de Toulouse - Hopital Larrey

Toulouse, Midi-Pyrénées, France

CHU Lille - Institut Coeur Poumon

Lille, Nord, France

Local Institution - 0689

Villejuif, Val-de-Marne, France

Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren

Limoges, France

Assistance Publique Hôpitaux de Marseille - Hôpital Nord

Marseille, France

Hopitaux Universitaires Paris Centre-Hopital Cochin

Paris, France

Klinikum Augsburg

Augsburg, Bavaria, Germany

Local Institution - 0929

Erlangen, Bavaria, Germany

Katholisches Klinikum-Koblenz Marienhof

Koblenz, Rhineland-Palatinate, Germany

Local Institution - 0174

Ludwigshafen am Rhein, Rhineland-Palatinate, Germany

Local Institution - 0172

Kiel, Schleswig-Holstein, Germany

Universitaetsklinikum Jena

Jena, Thuringia, Germany

Local Institution - 0217

Berlin, Germany

Local Institution - 0215

Berlin, Germany

Local Institution - 0169

Göttingen, Germany

Asklepios Fachkliniken Muenchen-Gauting

Gröbenzell, Germany

Krankenhaus Martha-Maria Halle-Doelau Ggmbh

Haile, Germany

LungenClinic Grosshansdorf GmbH

Hamburg, Germany

Lungenfachklinik Immenhausen

Immenhausen, Germany

Universitaetsklinikum Regensburg

Regensburg, Germany

Thoracic General Hospital of Athens "I Sotiria"

Athens, Attikí, Greece

General Hospital of Athens "Laiko"

Athens, Attikí, Greece

Papageorgiou General Hospital of Thessaloniki

Thessaloniki, Thessaloníki, Greece

G. Papanikolaou General Hospital

Thessaloniki, Thessaloníki, Greece

University General Hospital of Larissa

Larissa, Thessalía, Greece

Errikos Dunant Hospital Center

Athens, Greece

Local Institution - 0457

Tuenmen, NT, Hong Kong

Queen Mary Hospital

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 - 0927

Goraj, Gujarat, 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

St. James's Hospital

Dublin, Ireland

Beaumont Hospital, Dublin

Dublin, Ireland

Istituto Nazionale Tumori IRCCS Fondazione Pascale

Naples, Campania, Italy

Cro-Irccs

Aviano, Friuli Venezia Giulia, Italy

Azienda Ospedaliero-Universitaria San Luigi Gonzaga

Orbassano, Piedmont, Italy

Policlinico Universitario Campus Bio-Medico

Rome, Roma, Italy

Ospedale San Raffaele

Milan, Italy

Istituto Europeo di Oncologia IRCCS

Milan, Italy

Local Institution - 0390

Parma, Italy

Local Institution - 0670

Ravenna, Italy

Local Institution - 0014

Nagoya, Aichi-ken, Japan

Kobe University Hospital

Kobe, Hyōgo, Japan

Hyogo Medical University Hospital

Nishinomiya, Hyōgo, Japan

Kitasato University Hospital

Sagamihara, Kanagawa, Japan

Kanagawa cancer center

Yokohama, Kanagawa, Japan

Sendai Kousei Hospital

Sendai, Miyagi, Japan

Kindai University Hospital

Sakai, Osaka, Japan

Saitama Medical University International Medical Center

Hidaka, Saitama, Japan

Hamamatsu University Hospital

Hamamatsu, Shizuoka, Japan

Tokyo Metropolitan Komagome Hospital

Bunkyo Ku, Tokyo, Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan

Local Institution - 0016

Hirakata-shi, Japan

Okayama University Hospital

Okayama, Japan

Local Institution - 0759

Sendai, 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

University Medical Center Groningen

Groningen, Netherlands

Local Institution - 0092

Tilburg, Netherlands

Local Institution - 0473

Lublin, Lublin Voivodeship, Poland

SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu

Opole, Opole Voivodeship, Poland

Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu

Przemyśl, Podkarpackie Voivodeship, Poland

Local Institution - 0681

Katowice, Silesian Voivodeship, Poland

Centrul de Diagnostic si Tratament Provita

Bucharest, Bucharest, Romania

SC Radiotherapy Center Cluj SRL

Florești, Cluj, Romania

Spitalul Universitar de Urgență București

Bucharest, Romania

Institutul Oncologic Cluj

Cluj-Napoca, Romania

Centrul de Oncologie Sf. Nectarie SRL

Craiova, Romania

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

Iași, Romania

Institutul Regional de Oncologie

Iași, Romania

Oncomed

Timisoara, Timis, Romania

Local Institution - 0650

Singapore, Central Singapore, Singapore

Local Institution - 0647

Singapore, Singapore

Chungbuk National University Hospital

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

Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, 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

Seoul National University Hospital

Seoul, South Korea

Local Institution - 0041

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

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalunya [Cataluña], Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad de, Spain

Hospital Clinico de Valencia

Valencia, Valenciana, Comunitat, Spain

OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces

Barakaldo, Spain

Parc de Salut Mar - Hospital del Mar

Barcelona, Spain

Hospital Universitario Virgen De La Victoria

Málaga, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Spain

Sjukhuset I Gävle

Gävle, Gävleborgs Län [se-21], Sweden

Karolinska Universitetssjukhuset Solna

Solna, Stockholms Län [se-01], Sweden

Akademiska sjukhuset

Uppsala, Uppsala Län [se-03], Sweden

Universitaetsspital Basel

Basel, Switzerland

Ospedale Regionale Bellinzona e Valli

Bellinzona, Switzerland

Kantonsspital Münsterlingen - Spital Thurgau AG

Münsterlingen, Switzerland

Kantonsspital St Gallen

Sankt Gallen, Switzerland

National Taiwan University Hospital - Hsinchu branch

Zhubei, Hsinchu, Taiwan

Far Eastern Memorial Hospital

New Taipei City, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Taiwan University Hospital

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)

The Christie NHS Foundation Trust

Manchester, Lancashire, United Kingdom

Local Institution - 0932

Newcastle upon Tyne, North East, United Kingdom

Local Institution - 0928

Birmingham, West Midlands, 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

Local Institution - 0693

Leeds, United Kingdom

Clatterbridge Cancer Centre - Liverpool

Liverpool, United Kingdom

University College London Hospital

London, United Kingdom

Royal Marsden Hospital (Chelsea)

London, United Kingdom

Mount Vernon Hospital

Middlesex, United Kingdom

The Royal Marsden NHS Foundation Trust

Sutton, United Kingdom