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 (255) 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
Local Institution - 0585
NOT_YET_RECRUITING
Golden
Delaware
Medical Oncology Hematology Consultants, PA
RECRUITING
Newark
Florida
Local Institution - 0711
NOT_YET_RECRUITING
Ocala
Georgia
Local Institution - 0756
NOT_YET_RECRUITING
Marietta
Illinois
Local Institution - 0398
NOT_YET_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
Local Institution - 0656
NOT_YET_RECRUITING
Lexington
Massachusetts
Local Institution - 0603
NOT_YET_RECRUITING
Boston
Michigan
Local Institution - 0419
NOT_YET_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WITHDRAWN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
Local Institution - 0909
NOT_YET_RECRUITING
Westbury
Ohio
Local Institution - 0923
NOT_YET_RECRUITING
Akron
Local Institution - 0412
NOT_YET_RECRUITING
Cincinnati
Local Institution - 0359
NOT_YET_RECRUITING
Cleveland
Local Institution - 0597
NOT_YET_RECRUITING
Cleveland
Local Institution - 0924
NOT_YET_RECRUITING
Mayfield Heights
Oregon
Oncology Associates Of Oregon, Pc
RECRUITING
Eugene
Northwest Cancer Specialists, P.C.
RECRUITING
Happy Valley
Tennessee
Local Institution - 0480
NOT_YET_RECRUITING
Nashville
SCRI Oncology Partners
RECRUITING
Nashville
Texas
Texas Oncology - Amarillo Cancer Center
RECRUITING
Amarillo
Texas Oncology-Austin Central
RECRUITING
Austin
Texas Oncology
RECRUITING
Denton
Local Institution - 0811
NOT_YET_RECRUITING
Fort Worth
Local Institution - 0596
NOT_YET_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
Local Institution - 0093
NOT_YET_RECRUITING
Buenas Aires
Local Institution - 0078
NOT_YET_RECRUITING
Buenos Aires
Local Institution - 0094
NOT_YET_RECRUITING
Buenos Aires
Local Institution - 0761
NOT_YET_RECRUITING
Buenos Aires
Local Institution - 0313
NOT_YET_RECRUITING
Córdoba
Local Institution - 0608
NOT_YET_RECRUITING
Córdoba
Local Institution - 0082
NOT_YET_RECRUITING
Mar Del Plata
Local Institution - 0097
NOT_YET_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
Local Institution - 0446
NOT_YET_RECRUITING
Penrith
Local Institution - 0451
NOT_YET_RECRUITING
Wentworthville
Austria
Local Institution - 0190
NOT_YET_RECRUITING
Innsbruck
Local Institution - 0192
NOT_YET_RECRUITING
Linz
Local Institution - 0207
NOT_YET_RECRUITING
Vienna
Belgium
Local Institution - 0122
NOT_YET_RECRUITING
Anderlecht
Local Institution - 0906
NOT_YET_RECRUITING
Brasschaat
Local Institution - 0111
NOT_YET_RECRUITING
Charleroi
Local Institution - 0714
NOT_YET_RECRUITING
Genk
Local Institution - 0120
NOT_YET_RECRUITING
Ghent
Local Institution - 0116
NOT_YET_RECRUITING
Leuven
Local Institution - 0117
NOT_YET_RECRUITING
Sint-niklaas
Brazil
Local Institution - 0535
NOT_YET_RECRUITING
Barretos
Local Institution - 0498
NOT_YET_RECRUITING
Natal/rn
Local Institution - 0619
NOT_YET_RECRUITING
Porto Alegre
Local Institution - 0538
NOT_YET_RECRUITING
São José Do Rio Preto
Local Institution - 0912
NOT_YET_RECRUITING
São Paulo
Local Institution - 0615
NOT_YET_RECRUITING
Teresina
Bulgaria
Local Institution - 0736
NOT_YET_RECRUITING
Haskovo
Local Institution - 0551
NOT_YET_RECRUITING
Rousse
Local Institution - 0732
NOT_YET_RECRUITING
Sofia
Local Institution - 0826
NOT_YET_RECRUITING
Sofia
Local Institution - 0838
NOT_YET_RECRUITING
Sofia
Canada
Local Institution - 0644
NOT_YET_RECRUITING
Montreal
Local Institution - 0337
NOT_YET_RECRUITING
Ottawa
IUCPQ
RECRUITING
Québec
Chile
Local Institution - 0910
NOT_YET_RECRUITING
Antofagasta
Local Institution - 0855
NOT_YET_RECRUITING
Las Condes
Local Institution - 0037
NOT_YET_RECRUITING
Santiago
Local Institution - 0077
NOT_YET_RECRUITING
Santiago
Local Institution - 0478
NOT_YET_RECRUITING
Santiago
Local Institution - 0328
NOT_YET_RECRUITING
Viña Del Mar
China
Local Institution - 0754
NOT_YET_RECRUITING
Beijing
Local Institution - 0489
NOT_YET_RECRUITING
Changsha
Local Institution - 0440
NOT_YET_RECRUITING
Chengdu
Local Institution - 0835
NOT_YET_RECRUITING
Chengdu
Local Institution - 0308
NOT_YET_RECRUITING
Chongqing
Local Institution - 0245
NOT_YET_RECRUITING
Fuzhou
Local Institution - 0561
NOT_YET_RECRUITING
Guangzhou
Local Institution - 0301
NOT_YET_RECRUITING
Hangzhou
Local Institution - 0719
NOT_YET_RECRUITING
Hangzhou
Local Institution - 0297
NOT_YET_RECRUITING
Jinan
Local Institution - 0528
NOT_YET_RECRUITING
Jinan
Local Institution - 0911
NOT_YET_RECRUITING
Jingzhou
Local Institution - 0253
NOT_YET_RECRUITING
Linhai
Local Institution - 0254
NOT_YET_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
Local Institution - 0919
NOT_YET_RECRUITING
Shenzhen
Local Institution - 0918
NOT_YET_RECRUITING
Suzhou
Local Institution - 0542
NOT_YET_RECRUITING
Taiyuan
Local Institution - 0813
WITHDRAWN
Wuhan
Local Institution - 0921
NOT_YET_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
Local Institution - 0029
NOT_YET_RECRUITING
Bordeaux
Local Institution - 0129
NOT_YET_RECRUITING
Dijon
Local Institution - 0716
NOT_YET_RECRUITING
Lille
Local Institution - 0025
NOT_YET_RECRUITING
Limoges
Local Institution - 0130
NOT_YET_RECRUITING
Lyon Cedex08
Local Institution - 0024
NOT_YET_RECRUITING
Marseille
Local Institution - 0028
NOT_YET_RECRUITING
Montpellier
Local Institution - 0026
NOT_YET_RECRUITING
Paris
Local Institution - 0127
NOT_YET_RECRUITING
Saint-herblain
Local Institution - 0023
NOT_YET_RECRUITING
Toulouse
Local Institution - 0689
NOT_YET_RECRUITING
Villejuif
Germany
Local Institution - 0739
NOT_YET_RECRUITING
Augsburg
Local Institution - 0215
NOT_YET_RECRUITING
Berlin
Local Institution - 0217
NOT_YET_RECRUITING
Berlin
Local Institution - 0169
NOT_YET_RECRUITING
Göttingen
Local Institution - 0178
NOT_YET_RECRUITING
Gröbenzell
Local Institution - 0199
NOT_YET_RECRUITING
Haile
Local Institution - 0299
NOT_YET_RECRUITING
Hamburg
Local Institution - 0186
NOT_YET_RECRUITING
Immenhausen
Local Institution - 0182
NOT_YET_RECRUITING
Jena
Local Institution - 0172
NOT_YET_RECRUITING
Kiel
Local Institution - 0265
NOT_YET_RECRUITING
Koblenz
Local Institution - 0174
NOT_YET_RECRUITING
Ludwigshafen Am Rhein
Local Institution - 0187
NOT_YET_RECRUITING
Regensburg
Greece
Local Institution - 0323
NOT_YET_RECRUITING
Athens
Local Institution - 0324
NOT_YET_RECRUITING
Athens
Local Institution - 0391
NOT_YET_RECRUITING
Athens
Local Institution - 0321
NOT_YET_RECRUITING
Larissa
Local Institution - 0416
NOT_YET_RECRUITING
Thessaloniki
Local Institution - 0697
NOT_YET_RECRUITING
Thessaloniki
Hong Kong Special Administrative Region
Local Institution - 0193
NOT_YET_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
Local Institution - 0070
NOT_YET_RECRUITING
Dublin
Local Institution - 0270
NOT_YET_RECRUITING
Dublin
Italy
Local Institution - 0269
NOT_YET_RECRUITING
Aviano (pn)
Local Institution - 0667
NOT_YET_RECRUITING
Milan
Local Institution - 0668
NOT_YET_RECRUITING
Milan
Local Institution - 0275
NOT_YET_RECRUITING
Naples
Local Institution - 0304
NOT_YET_RECRUITING
Orbassano
Local Institution - 0390
NOT_YET_RECRUITING
Parma
Local Institution - 0670
NOT_YET_RECRUITING
Ravenna
Local Institution - 0669
NOT_YET_RECRUITING
Rome
Japan
Local Institution - 0018
NOT_YET_RECRUITING
Bunkyo Ku
Hamamatsu University Hospital
RECRUITING
Hamamatsu
Local Institution - 0149
NOT_YET_RECRUITING
Hidaka
Local Institution - 0016
NOT_YET_RECRUITING
Hirakata-shi
Local Institution - 0701
NOT_YET_RECRUITING
Kobe
Local Institution - 0009
NOT_YET_RECRUITING
Minami-ku, Fukuoka
Local Institution - 0014
NOT_YET_RECRUITING
Nagoya
Hyogo Medical University Hospital
RECRUITING
Nishinomiya
Local Institution - 0907
NOT_YET_RECRUITING
Okayama
Local Institution - 0157
NOT_YET_RECRUITING
Sagamihara
Kindai University Hospital
RECRUITING
Sakai
Local Institution - 0001
NOT_YET_RECRUITING
Sendai
Local Institution - 0759
NOT_YET_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
Local Institution - 0089
NOT_YET_RECRUITING
Groningen
Local Institution - 0243
NOT_YET_RECRUITING
Nijmegen
Local Institution - 0092
NOT_YET_RECRUITING
Tilburg
Local Institution - 0087
NOT_YET_RECRUITING
Zwolle
Poland
Local Institution - 0681
NOT_YET_RECRUITING
Katowice
Local Institution - 0473
NOT_YET_RECRUITING
Lublin
Local Institution - 0680
NOT_YET_RECRUITING
Opole
Local Institution - 0556
NOT_YET_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
Local Institution - 0046
NOT_YET_RECRUITING
Bucharest
Local Institution - 0219
NOT_YET_RECRUITING
Bucharest
Local Institution - 0168
NOT_YET_RECRUITING
Cluj-napoca
Local Institution - 0045
NOT_YET_RECRUITING
Craiova
Local Institution - 0058
NOT_YET_RECRUITING
Floresti/ Cluj
Local Institution - 0164
NOT_YET_RECRUITING
Iași
Local Institution - 0184
NOT_YET_RECRUITING
Iași
Singapore
Local Institution - 0647
NOT_YET_RECRUITING
Singapore
Local Institution - 0650
NOT_YET_RECRUITING
Singapore
Spain
Local Institution - 0086
NOT_YET_RECRUITING
Barakaldo
Local Institution - 0042
NOT_YET_RECRUITING
Barcelona
Local Institution - 0043
NOT_YET_RECRUITING
Barcelona
Local Institution - 0041
NOT_YET_RECRUITING
L'hospitalet Del Llobregat
Local Institution - 0049
NOT_YET_RECRUITING
Madrid
Local Institution - 0570
NOT_YET_RECRUITING
Málaga
Local Institution - 0061
NOT_YET_RECRUITING
Seville
Local Institution - 0066
NOT_YET_RECRUITING
Valencia
Local Institution - 0044
NOT_YET_RECRUITING
Zaragoza
Sweden
Local Institution - 0033
NOT_YET_RECRUITING
Gävle
Local Institution - 0032
NOT_YET_RECRUITING
Solna
Local Institution - 0034
NOT_YET_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
Local Institution - 0735
NOT_YET_RECRUITING
Chiayi City
Local Institution - 0729
NOT_YET_RECRUITING
Taipei
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
Addenbrooke's Hospital
RECRUITING
Cambridge
Velindre Cancer Centre
RECRUITING
Cardiff
Local Institution - 0257
NOT_YET_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
Local Institution - 0533
NOT_YET_RECRUITING
Middlesex
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