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
Local Institution - 0317
NOT_YET_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
Flint
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
Local Institution - 0606
NOT_YET_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WITHDRAWN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
Local Institution - 0442
NOT_YET_RECRUITING
Ballarat
Local Institution - 0448
NOT_YET_RECRUITING
Elizabeth Vale
Local Institution - 0458
NOT_YET_RECRUITING
Epping
Local Institution - 0456
NOT_YET_RECRUITING
Gosford
Local Institution - 0476
NOT_YET_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
Local Institution - 0682
NOT_YET_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
Local Institution - 0298
NOT_YET_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 - 0021
NOT_YET_RECRUITING
Paris
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 - 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
Local Institution - 0158
NOT_YET_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
Local Institution - 0154
NOT_YET_RECRUITING
Nishinomiya-shi
Local Institution - 0907
NOT_YET_RECRUITING
Okayama
Local Institution - 0002
NOT_YET_RECRUITING
Osakasayama-shi
Local Institution - 0157
NOT_YET_RECRUITING
Sagamihara
Local Institution - 0001
NOT_YET_RECRUITING
Sendai
Local Institution - 0759
NOT_YET_RECRUITING
Sendai
Local Institution - 0008
NOT_YET_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
Local Institution - 0052
NOT_YET_RECRUITING
Cheongju-si
Local Institution - 0151
NOT_YET_RECRUITING
Seongnam
Local Institution - 0035
NOT_YET_RECRUITING
Seoul
Local Institution - 0055
NOT_YET_RECRUITING
Seoul
Local Institution - 0063
NOT_YET_RECRUITING
Seoul
Local Institution - 0064
NOT_YET_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
Local Institution - 0222
NOT_YET_RECRUITING
Basel
Local Institution - 0166
NOT_YET_RECRUITING
Bellinzona
Local Institution - 0738
NOT_YET_RECRUITING
Münsterlingen
Local Institution - 0165
NOT_YET_RECRUITING
Sankt Gallen
Taiwan
Local Institution - 0735
NOT_YET_RECRUITING
Chiayi City
Local Institution - 0726
NOT_YET_RECRUITING
Taipei
Local Institution - 0729
NOT_YET_RECRUITING
Taipei
Local Institution - 0734
NOT_YET_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 - 0672
NOT_YET_RECRUITING
Cambridge
Local Institution - 0289
NOT_YET_RECRUITING
Cardiff
Local Institution - 0257
NOT_YET_RECRUITING
Guildford
Local Institution - 0693
NOT_YET_RECRUITING
Leeds
Local Institution - 0232
NOT_YET_RECRUITING
Liverpool
Local Institution - 0235
NOT_YET_RECRUITING
London
Local Institution - 0296
NOT_YET_RECRUITING
London
Local Institution - 0239
NOT_YET_RECRUITING
Manchester
Local Institution - 0533
NOT_YET_RECRUITING
Middlesex
Local Institution - 0913
NOT_YET_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