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.
Status: Recruiting
Location: See all (259) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participants must have a histologically- or cytologically-confirmed diagnoses of non-small cell lung cancer (NSCLC) with unresectable Stage III disease.
• Participants must have received at least 2 cycles of platinum-based concurrent chemoradiotherapy (a total dose of radiation of at least 54 Gy).
• Participants must have no progressive disease (PD) following treatment with concurrent chemoradiotherapy (CCRT).
• Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
Locations
United States
Alabama
Southern Cancer Center Pc
RECRUITING
Daphne
Arizona
Local Institution - 0780
NOT_YET_RECRUITING
Chandler
Colorado
Intermountain Health Cancer Center Lutheran Hospital
RECRUITING
Golden
Delaware
Medical Oncology Hematology Consultants, PA
RECRUITING
Newark
Florida
Local Institution - 0711
NOT_YET_RECRUITING
Ocala
Georgia
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
RECRUITING
Marietta
Illinois
University of Chicago Medical Center
RECRUITING
Chicago
Local Institution - 0850
NOT_YET_RECRUITING
Evanston
Illinois Cancer Care
RECRUITING
Peoria
Indiana
Fort Wayne Medical Oncology and Hematology
RECRUITING
Fort Wayne
Kentucky
University of Kentucky Chandler Medical Center
RECRUITING
Lexington
Massachusetts
Local Institution - 0603
NOT_YET_RECRUITING
Boston
Michigan
Karmanos Cancer Institute
RECRUITING
Detroit
Minnesota
Minnesota Oncology Hematology
RECRUITING
Maple Grove
Local Institution - 0142
NOT_YET_RECRUITING
Saint Paul
Missouri
Missouri Cancer Associates
RECRUITING
Columbia
North Carolina
Local Institution - 0493
NOT_YET_RECRUITING
Winston-salem
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Local Institution - 0339
WITHDRAWN
Westbury
Optum Medical Care, PC
RECRUITING
Westbury
Ohio
Local Institution - 0923
NOT_YET_RECRUITING
Akron
The Christ Hospital
RECRUITING
Cincinnati
Cleveland Clinic
RECRUITING
Cleveland
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Cleveland Clinic - Hillcrest Hospital
RECRUITING
Mayfield Heights
Oregon
Oncology Associates Of Oregon, Pc
RECRUITING
Eugene
Northwest Cancer Specialists, P.C.
RECRUITING
Happy Valley
Tennessee
SCRI Oncology Partners
RECRUITING
Nashville
Tennessee Oncology
RECRUITING
Nashville
Texas
Texas Oncology - Amarillo Cancer Center
RECRUITING
Amarillo
Texas Oncology-Austin Central
RECRUITING
Austin
Texas Oncology
RECRUITING
Denton
The Center For Cancer And Blood Disorders
RECRUITING
Fort Worth
The University of Texas-MD Anderson Cancer Center
RECRUITING
Houston
Texas Oncology - San Antonio Medical Center
RECRUITING
San Antonio
Texas Oncology - Northeast Texas
RECRUITING
Tyler
Virginia
Blue Ridge Cancer Care
RECRUITING
Christiansburg
Virginia Oncology Associates
RECRUITING
Norfolk
Other Locations
Argentina
Instituto Argentino De Diagnostico Y Tratamiento IADT
RECRUITING
Buenas Aires
Clinica Adventista Belgrano
RECRUITING
Buenos Aires
Hospital Italiano de Buenos Aires
RECRUITING
Buenos Aires
Instituto Medico Especializado Alexander Fleming
RECRUITING
Buenos Aires
Hospital Privado Universitario de Córdoba
RECRUITING
Córdoba
Instituto de Investigaciones Clínicas Córdoba S.A.
RECRUITING
Córdoba
Local Institution - 0082
NOT_YET_RECRUITING
Mar Del Plata
Sanatorio Parque Rosario
RECRUITING
Rosario
Australia
Grampians Health
RECRUITING
Ballarat Central
Lyell McEwin Hospital
RECRUITING
Elizabeth Vale
Local Institution - 0458
NOT_YET_RECRUITING
Epping
Gosford Hospital
RECRUITING
Gosford
Joondalup Health Campus
RECRUITING
Joondalup
Nepean Hospital
RECRUITING
Penrith
Westmead Hospital
RECRUITING
Westmead
Austria
Universitätsklinik Innsbruck
RECRUITING
Innsbruck
Ordensklinikum Linz GmbH Elisabethinen
RECRUITING
Linz
Medizinische Universitaet Wien/AKH
RECRUITING
Vienna
Belgium
Local Institution - 0122
NOT_YET_RECRUITING
Anderlecht
Algemeen Ziekenhuis klina
RECRUITING
Brasschaat
Local Institution - 0111
NOT_YET_RECRUITING
Charleroi
Ziekenhuis Oost-Limburg, Campus St.-Jan
RECRUITING
Genk
UZ Gent
RECRUITING
Ghent
UZ Leuven
RECRUITING
Leuven
VITAZ
RECRUITING
Sint-niklaas
Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
RECRUITING
Barretos
Liga Norte Riograndense Contra o Câncer
RECRUITING
Natal
Hospital de Clinicas de Porto Alegre
RECRUITING
Porto Alegre
Fundação Faculdade Regional de Medicina de São José do Rio Preto
RECRUITING
São José Do Rio Preto
Local Institution - 0912
NOT_YET_RECRUITING
São Paulo
Vencer Centro de Pesquisa LTDA
RECRUITING
Teresina
Bulgaria
Multiprofile Hospital for Active Treatment - Haskovo AD
RECRUITING
Haskovo
Complex Oncology Center - Ruse EOOD
RECRUITING
Rousse
Diagnostic and Consultative Center Convex
RECRUITING
Sofia
Local Institution - 0732
NOT_YET_RECRUITING
Sofia
Sveta Ekaterina Hospital
RECRUITING
Sofia
Canada
St. Marys Hospital Center
RECRUITING
Montreal
The Ottawa Hospital - General Campus
RECRUITING
Ottawa
IUCPQ
RECRUITING
Québec
Chile
Bradford Hill Norte
RECRUITING
Antofagasta
Local Institution - 0855
NOT_YET_RECRUITING
Las Condes
FALP
RECRUITING
Santiago
Local Institution - 0077
NOT_YET_RECRUITING
Santiago
Oncocentro APYS - Centro de Atencion Medica Oncologica Integral
RECRUITING
Viña Del Mar
China
Beijing Cancer hospital
RECRUITING
Beijing
Local Institution - 0489
NOT_YET_RECRUITING
Changsha
Local Institution - 0440
NOT_YET_RECRUITING
Chengdu
Sichuan Cancer hospital
RECRUITING
Chengdu
Chongqing University Cancer Hospital
RECRUITING
Chongqing
Fujian Cancer Hospital
RECRUITING
Fuzhou
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Local Institution - 0301
NOT_YET_RECRUITING
Hangzhou
The second Affiliated Hospital of College of Medicine, Zhejiang University
RECRUITING
Hangzhou
Qilu Hospital of Shandong University
RECRUITING
Jinan
Shandong Cancer Hospital
RECRUITING
Jinan
Jingzhou First People's Hospital
RECRUITING
Jingzhou
Taizhou Hospital Of Zhejiang Province
RECRUITING
Linhai
The Second Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Local Institution - 0248
NOT_YET_RECRUITING
Shanghai
Local Institution - 0537
NOT_YET_RECRUITING
Shanghai Shi
Cancer Hospital of Shantou University Medical College
RECRUITING
Shantou
Local Institution - 0242
NOT_YET_RECRUITING
Shenyang
Peking University Shenzhen Hospital
RECRUITING
Shenzhen
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Shanxi Cancer Hospital
RECRUITING
Taiyuan
Local Institution - 0813
WITHDRAWN
Wuhan
The Central Hospital of Wuhan
RECRUITING
Wuhan
Local Institution - 0527
NOT_YET_RECRUITING
Xi'an
Local Institution - 0564
NOT_YET_RECRUITING
Xi'an
Local Institution - 0249
NOT_YET_RECRUITING
Zhengzhou
France
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
RECRUITING
Bordeaux
Local Institution - 0129
NOT_YET_RECRUITING
Dijon
CHU Lille - Institut Coeur Poumon
RECRUITING
Lille
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren
RECRUITING
Limoges
Centre Leon Berard
RECRUITING
Lyon Cedex08
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
RECRUITING
Marseille
Institut Régional du Cancer Montpellier
RECRUITING
Montpellier
Hopitaux Universitaires Paris Centre-Hopital Cochin
RECRUITING
Paris
Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes
RECRUITING
Saint-herblain
CHU de Toulouse - Hopital Larrey
RECRUITING
Toulouse
Local Institution - 0689
NOT_YET_RECRUITING
Villejuif
Germany
Klinikum Augsburg
RECRUITING
Augsburg
Local Institution - 0215
NOT_YET_RECRUITING
Berlin
Local Institution - 0217
NOT_YET_RECRUITING
Berlin
Local Institution - 0929
NOT_YET_RECRUITING
Erlangen
Local Institution - 0169
WITHDRAWN
Göttingen
Asklepios Fachkliniken Muenchen-Gauting
RECRUITING
Gröbenzell
Krankenhaus Martha-Maria Halle-Doelau Ggmbh
RECRUITING
Haile
LungenClinic Grosshansdorf GmbH
RECRUITING
Hamburg
Lungenfachklinik Immenhausen
RECRUITING
Immenhausen
Universitaetsklinikum Jena
RECRUITING
Jena
Universitatsklinikum Schleswig-Holstein
RECRUITING
Kiel
Katholisches Klinikum-Koblenz Marienhof
RECRUITING
Koblenz
Klinikum der Stadt Ludwigshafen gGmbH
RECRUITING
Ludwigshafen Am Rhein
Local Institution - 0934
NOT_YET_RECRUITING
Magdeburg
Universitaetsklinikum Regensburg
RECRUITING
Regensburg
Greece
Errikos Dunant Hospital Center
RECRUITING
Athens
General Hospital of Athens Laiko
RECRUITING
Athens
Thoracic General Hospital of Athens I Sotiria
RECRUITING
Athens
University General Hospital of Larissa
RECRUITING
Larissa
G. Papanikolaou General Hospital
RECRUITING
Thessaloniki
Papageorgiou General Hospital of Thessaloniki
RECRUITING
Thessaloniki
Hong Kong Special Administrative Region
Queen Mary Hospital
RECRUITING
Hksar
Local Institution - 0764
NOT_YET_RECRUITING
Shatin
Local Institution - 0457
NOT_YET_RECRUITING
Tuenmen
Hungary
Local Institution - 0138
NOT_YET_RECRUITING
Budapest
Local Institution - 0776
NOT_YET_RECRUITING
Farkasgyepű
Local Institution - 0139
NOT_YET_RECRUITING
Kecskemét
Local Institution - 0787
NOT_YET_RECRUITING
Szolnok
Local Institution - 0696
NOT_YET_RECRUITING
Törökbálint
India
Local Institution - 0864
NOT_YET_RECRUITING
Aurangabad
Local Institution - 0547
NOT_YET_RECRUITING
Delhi
Local Institution - 0664
NOT_YET_RECRUITING
Dwarka
Local Institution - 0840
NOT_YET_RECRUITING
Eluru
Local Institution - 0927
NOT_YET_RECRUITING
Goraj
Local Institution - 0657
NOT_YET_RECRUITING
Hyderabad
Local Institution - 0660
NOT_YET_RECRUITING
Mumbai
Local Institution - 0663
NOT_YET_RECRUITING
Mumbai
Local Institution - 0661
NOT_YET_RECRUITING
Nagpur
Local Institution - 0856
NOT_YET_RECRUITING
New Delhi
Local Institution - 0548
NOT_YET_RECRUITING
Pūlakkōd
Local Institution - 0659
NOT_YET_RECRUITING
Pune
Ireland
Local Institution - 0276
NOT_YET_RECRUITING
Cork
Beaumont Hospital, Dublin
RECRUITING
Dublin
St. James's Hospital
RECRUITING
Dublin
Italy
Cro-Irccs
RECRUITING
Aviano
Istituto Europeo di Oncologia IRCCS
RECRUITING
Milan
Ospedale San Raffaele
RECRUITING
Milan
Istituto Nazionale Tumori IRCCS Fondazione Pascale
RECRUITING
Naples
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
RECRUITING
Orbassano
Local Institution - 0390
NOT_YET_RECRUITING
Parma
Ospedale Santa Maria delle Croci
RECRUITING
Ravenna
Policlinico Universitario Campus Bio-Medico
RECRUITING
Rome
Japan
Tokyo Metropolitan Komagome Hospital
RECRUITING
Bunkyo Ku
National Hospital Organization Kyushu Cancer Center
RECRUITING
Fukuoka
Hamamatsu University Hospital
RECRUITING
Hamamatsu
Saitama Medical University International Medical Center
RECRUITING
Hidaka
Kansai Medical University Hospital
RECRUITING
Hirakata
Kobe University Hospital
RECRUITING
Kobe
Local Institution - 0014
NOT_YET_RECRUITING
Nagoya
Hyogo Medical University Hospital
RECRUITING
Nishinomiya
Okayama University Hospital
RECRUITING
Okayama
Kitasato University Hospital
RECRUITING
Sagamihara
Kindai University Hospital
RECRUITING
Sakai
Local Institution - 0759
NOT_YET_RECRUITING
Sendai
Sendai Kousei Hospital
RECRUITING
Sendai
Kanagawa cancer center
RECRUITING
Yokohama
Mexico
Local Institution - 0330
NOT_YET_RECRUITING
Monterrey
Local Institution - 0914
NOT_YET_RECRUITING
Puebla City
Local Institution - 0349
NOT_YET_RECRUITING
Querétaro
Local Institution - 0772
NOT_YET_RECRUITING
Saltillo
Local Institution - 0815
NOT_YET_RECRUITING
Tijuana
Local Institution - 0699
NOT_YET_RECRUITING
Zapopan
Netherlands
Local Institution - 0091
NOT_YET_RECRUITING
Amsterdam
Local Institution - 0095
NOT_YET_RECRUITING
Breda
University Medical Center Groningen
RECRUITING
Groningen
Local Institution - 0243
NOT_YET_RECRUITING
Nijmegen
Local Institution - 0092
NOT_YET_RECRUITING
Tilburg
Local Institution - 0087
NOT_YET_RECRUITING
Zwolle
Poland
Uniwersyteckie Centrum Kliniczne im. prof. K.Gibinskiego SUM w Katowicach
RECRUITING
Katowice
Local Institution - 0473
NOT_YET_RECRUITING
Lublin
SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
RECRUITING
Opole
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
RECRUITING
Przemyśl
Republic of Korea
Chungbuk National University Hospital
RECRUITING
Cheongju-si
Seoul National University Bundang Hospital
RECRUITING
Seongnam
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Romania
Centrul de Diagnostic si Tratament Provita
RECRUITING
Bucharest
Spitalul Universitar de Urgență București
RECRUITING
Bucharest
Institutul Oncologic Cluj
RECRUITING
Cluj-napoca
Centrul de Oncologie Sf. Nectarie SRL
RECRUITING
Craiova
SC Radiotherapy Center Cluj SRL
RECRUITING
Florești
Institutul Regional de Oncologie
RECRUITING
Iași
S.C. Centrul de Oncologie Euroclinic S.R.L.
RECRUITING
Iași
Oncomed
RECRUITING
Timisoara, Timis
Singapore
Local Institution - 0647
NOT_YET_RECRUITING
Singapore
National Cancer Centre Singapore
RECRUITING
Singapore
Spain
OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces
RECRUITING
Barakaldo
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Parc de Salut Mar - Hospital del Mar
RECRUITING
Barcelona
Local Institution - 0041
NOT_YET_RECRUITING
L'hospitalet Del Llobregat
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Virgen De La Victoria
RECRUITING
Málaga
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Hospital Clinico de Valencia
RECRUITING
Valencia
Hospital Clínico Universitario Lozano Blesa
RECRUITING
Zaragoza
Sweden
Sjukhuset I Gävle
RECRUITING
Gävle
Karolinska Universitetssjukhuset Solna
RECRUITING
Solna
Akademiska sjukhuset
RECRUITING
Uppsala
Switzerland
Universitaetsspital Basel
RECRUITING
Basel
Ospedale Regionale Bellinzona e Valli
RECRUITING
Bellinzona
Kantonsspital Münsterlingen - Spital Thurgau AG
RECRUITING
Münsterlingen
Kantonsspital St Gallen
RECRUITING
Sankt Gallen
Taiwan
Far Eastern Memorial Hospital
RECRUITING
New Taipei City
Taichung Veterans General Hospital
RECRUITING
Taichung
National Taiwan University Hospital
RECRUITING
Taipei
National Taiwan University Hospital - Hsinchu branch
RECRUITING
Zhubei
Thailand
Local Institution - 0733
NOT_YET_RECRUITING
Bangkok
Local Institution - 0917
NOT_YET_RECRUITING
Chiang Mai
Local Institution - 0160
NOT_YET_RECRUITING
Khon Kaen
Local Institution - 0728
NOT_YET_RECRUITING
Songkhla
Turkey
Local Institution - 0099
NOT_YET_RECRUITING
Adana
Local Institution - 0113
NOT_YET_RECRUITING
Adana
Local Institution - 0198
NOT_YET_RECRUITING
Antalya
Local Institution - 0109
NOT_YET_RECRUITING
Çankaya
Local Institution - 0096
NOT_YET_RECRUITING
Istanbul
Local Institution - 0107
NOT_YET_RECRUITING
Istanbul
United Kingdom
Local Institution - 0928
NOT_YET_RECRUITING
Birmingham
Addenbrooke's Hospital
RECRUITING
Cambridge
Velindre Cancer Centre
RECRUITING
Cardiff
The Royal Surrey County Hospital NHS Foundation Trust
RECRUITING
Guildford
Local Institution - 0693
WITHDRAWN
Leeds
Clatterbridge Cancer Centre - Liverpool
RECRUITING
Liverpool
Royal Marsden Hospital (Chelsea)
RECRUITING
London
University College London Hospital
RECRUITING
London
The Christie NHS Foundation Trust
RECRUITING
Manchester
Mount Vernon Hospital
RECRUITING
Middlesex
Local Institution - 0932
NOT_YET_RECRUITING
Newcastle Upon Tyne
The Royal Marsden NHS Foundation Trust
RECRUITING
Sutton
Contact Information
Primary
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain NCT # and Site #.
Time Frame
Start Date: 2026-03-16
Estimated Completion Date: 2033-12-31
Participants
Target number of participants: 850
Treatments
Experimental: Arm A
Active_comparator: Arm B
Related Therapeutic Areas
Sponsors
Leads: Bristol-Myers Squibb
Collaborators: BioNTech SE