ROSETTA Lung-202: A Randomized, Double-Blind, Phase 3 Study of Pumitamig Monotherapy Compared to Pembrolizumab as First-line Treatment in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With PD-L1 ≥ 50%.
Status: Recruiting
Location: See all (275) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to evaluate the efficacy of Pumitamig versus Pembrolizumab in participants with previously untreated advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participants must have a histologically or cytologically confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC) (squamous and nonsquamous) with Stage IIIB/IIIC or Stage IV disease.
• Participants must have a programmed death ligand-1 (PD-L1) expression ≥ 50%.
• Participants must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
• Participants must have no prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC.
• Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
Locations
United States
Alabama
Southern Cancer Center Pc
RECRUITING
Daphne
Arizona
Mohtaseb Cancer Center & Blood Disorders
RECRUITING
Bullhead City
Palo Verde Hematology Oncology
RECRUITING
Glendale
California
Beverly Hills Cancer Center
RECRUITING
Beverly Hills
Orange Coast Memorial Medical Center
RECRUITING
Fountain Valley
Local Institution - 0027
NOT_YET_RECRUITING
Los Alamitos
Local Institution - 0422
NOT_YET_RECRUITING
Los Angeles
Pacific Cancer Care
RECRUITING
Monterey
Local Institution - 0403
NOT_YET_RECRUITING
Oakland
Local Institution - 0208
NOT_YET_RECRUITING
Pleasant Hill
BASS Cancer Center
RECRUITING
Walnut Creek
Colorado
Local Institution - 0340
NOT_YET_RECRUITING
Lakewood
Florida
Clermont Oncology Center
RECRUITING
Clermont
Advanced Research
RECRUITING
Coral Springs
BRP- Hialeah Hospital
RECRUITING
Hialeah
Florida Clinical Trials Group
RECRUITING
Tamarac
Georgia
University Cancer & Blood Center, LLC
RECRUITING
Athens
Local Institution - 0412
NOT_YET_RECRUITING
Augusta
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
RECRUITING
Marietta
Illinois
Local Institution - 0423
NOT_YET_RECRUITING
Urbana
Indiana
Northwest Cancer Centers, P.C.
RECRUITING
Dyer
Missouri
Missouri Cancer Associates
RECRUITING
Columbia
North Carolina
Novant Health Pharmacy Oncology Specialists
RECRUITING
Winston-salem
New York
Local Institution - 0224
NOT_YET_RECRUITING
Laurelton
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Optum Medical Care, PC
RECRUITING
Westbury
Ohio
Local Institution - 0383
NOT_YET_RECRUITING
Cincinnati
Oklahoma
Local Institution - 0418
NOT_YET_RECRUITING
Oklahoma City
Pennsylvania
Lancaster General Hospital
RECRUITING
Lancaster
Local Institution - 0028
NOT_YET_RECRUITING
Pittsburgh
WellSpan Oncology Research
RECRUITING
York
Texas
University Of Texas Medical Branch At Galveston
RECRUITING
Galveston
Kelsey-Seybold Clinic Main Campus
RECRUITING
Houston
Local Institution - 0381
NOT_YET_RECRUITING
San Antonio
Texas Oncology - San Antonio
RECRUITING
San Antonio
Virginia
Local Institution - 0337
NOT_YET_RECRUITING
Richmond
Shenandoah Oncology, P.C.
RECRUITING
Winchester
Washington
Local Institution - 0384
NOT_YET_RECRUITING
Spokane
Wisconsin
HSHS St. Vincent Hospital Regional Cancer Center
RECRUITING
Green Bay
Local Institution - 0421
NOT_YET_RECRUITING
Marshfield
West Virginia
Charleston Area Medical Center (CAMC)
RECRUITING
Charleston
Other Locations
Argentina
Clinica Adventista Belgrano
RECRUITING
Buenos Aires
Hospital Italiano De Cordoba
RECRUITING
Córdoba
Local Institution - 0076
NOT_YET_RECRUITING
Mar Del Plata
Fundacion Estudios Clinicos
RECRUITING
Rosario
Sanatorio Plaza
RECRUITING
Rosario
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
RECRUITING
San Miguel De Tucumán
Australia
Grampians Health
RECRUITING
Ballarat Central
Lyell McEwin Hospital
RECRUITING
Elizabeth Vale
Local Institution - 0201
NOT_YET_RECRUITING
Epping
Gosford Hospital
RECRUITING
Gosford
Joondalup Health Campus
RECRUITING
Joondalup
Nepean Hospital
RECRUITING
Penrith
Austria
Landeskrankenhaus Feldkirch
RECRUITING
Feldkirch
Kepler Universitaetsklinikum
RECRUITING
Linz
Universitätsklinikum St. Pölten
RECRUITING
Sankt Pölten
Belgium
Local Institution - 0333
NOT_YET_RECRUITING
Auderghem
Algemeen Ziekenhuis klina
RECRUITING
Brasschaat
UZ Leuven
RECRUITING
Leuven
ZAS Augustinus
RECRUITING
Wilrijk
Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
RECRUITING
Barretos
Crio - Centro Regional Integrado de Oncologia
RECRUITING
Fortaleza
Liga Norte Riograndense Contra o Câncer
RECRUITING
Natal
Hospital São Lucas da PUCRS - Porto Alegre
RECRUITING
Porto Alegre
A. C. Camargo Cancer Center
RECRUITING
São Paulo
Centro Paulista de Oncologia Clínica
RECRUITING
São Paulo
Instituto do Cancer Brasil - Taubate
RECRUITING
Taubaté
Bulgaria
Complex Oncology Center - Ruse EOOD
RECRUITING
Rousse
Diagnostic and Consultative Center Convex
RECRUITING
Sofia
Local Institution - 0047
NOT_YET_RECRUITING
Sofia
Sveta Ekaterina Hospital
RECRUITING
Sofia
Canada
Local Institution - 0002
NOT_YET_RECRUITING
Halifax
Local Institution - 0414
NOT_YET_RECRUITING
Oshawa
Local Institution - 0178
NOT_YET_RECRUITING
Ottawa
Local Institution - 0411
NOT_YET_RECRUITING
Prince George
Local Institution - 0156
NOT_YET_RECRUITING
Toronto
Chile
Bradford Hill Norte
RECRUITING
Antofagasta
Servicios Medicos e Investigacion Biocenter SpA
RECRUITING
Concepción
Local Institution - 0150
NOT_YET_RECRUITING
Independencia
Centro de Oncología de Precisión
RECRUITING
Las Condes
Bradfordhill
RECRUITING
Santiago
China
Local Institution - 0113
NOT_YET_RECRUITING
Beijing
Local Institution - 0175
NOT_YET_RECRUITING
Beijing
Local Institution - 0004
NOT_YET_RECRUITING
Changsha
Local Institution - 0435
NOT_YET_RECRUITING
Changsha
Sichuan Cancer hospital
RECRUITING
Chengdu
Fujian Cancer Hospital
RECRUITING
Fuzhou
Nanfang Medical College Nanfang Hospital
RECRUITING
Guangzhou
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
The Second Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Local Institution - 0317
NOT_YET_RECRUITING
Harbin
Local Institution - 0429
NOT_YET_RECRUITING
Jinan
Shandong Cancer Hospital
RECRUITING
Jinan
Local Institution - 0123
NOT_YET_RECRUITING
Linyi
The Second Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Local Institution - 0316
NOT_YET_RECRUITING
Nanjing
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
RECRUITING
Nanjing
Guangxi Medical University Affiliated Tumor Hospital
RECRUITING
Nanning
Shanghai East Hospital
RECRUITING
Shanghai
Local Institution - 0122
NOT_YET_RECRUITING
Shanghai Shi
Local Institution - 0212
NOT_YET_RECRUITING
Shanghai Shi
Cancer Hospital of Shantou University Medical College
RECRUITING
Shantou
Local Institution - 0177
NOT_YET_RECRUITING
Shenyang
Local Institution - 0430
NOT_YET_RECRUITING
Wuhan
Local Institution - 0014
WITHDRAWN
Xi'an
Local Institution - 0141
NOT_YET_RECRUITING
Xiamen
Zhangzhou Municipal Hospital of Fujian Province
RECRUITING
Zhangzhou
Local Institution - 0046
NOT_YET_RECRUITING
Zhengzhou
Colombia
Local Institution - 0328
NOT_YET_RECRUITING
Barranquilla
Local Institution - 0218
NOT_YET_RECRUITING
Bogotá
Local Institution - 0441
NOT_YET_RECRUITING
Bogotá
Local Institution - 0307
NOT_YET_RECRUITING
Medellín
Local Institution - 0310
NOT_YET_RECRUITING
Rionegro
Finland
Kuopion Yliopistollinen Sairaala
RECRUITING
Kuopio
Tampereen yliopistollinen sairaala
RECRUITING
Tampere
Vaasan Keskussairaala
RECRUITING
Vaasa
France
Centre Hospitalier Universitaire (CHU) Dijon Bourgogne
RECRUITING
Dijon
Local Institution - 0144
NOT_YET_RECRUITING
La Tronche
Local Institution - 0162
WITHDRAWN
Lille
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren
RECRUITING
Limoges
Local Institution - 0151
WITHDRAWN
Marseille
Local Institution - 0239
WITHDRAWN
Montpellier
Local Institution - 0398
NOT_YET_RECRUITING
Nice
Hopitaux Universitaires Paris Centre-Hopital Cochin
RECRUITING
Paris
Local Institution - 0207
NOT_YET_RECRUITING
Paris
CHU Bordeaux Haut-Leveque
RECRUITING
Pessac
Centre Hospitalier de Cornouaille Quimper - Concarneau
RECRUITING
Quimper
Institut Jean Godinot
RECRUITING
Reims
Local Institution - 0057
WITHDRAWN
Saint-herblain
Local Institution - 0059
WITHDRAWN
Toulouse
Germany
Local Institution - 0231
NOT_YET_RECRUITING
Berlin
Local Institution - 0158
NOT_YET_RECRUITING
Braunschweig
Local Institution - 0432
NOT_YET_RECRUITING
Cologne
GEFOS Society for Oncological Studies
RECRUITING
Dortmund
HELIOS Klinikum Erfurt
RECRUITING
Erfurt
Kliniken Essen-Mitte/Huyssens-Stift
RECRUITING
Essen
SRH Wald-Klinikum Gera GmbH
RECRUITING
Gera
Local Institution - 0071
WITHDRAWN
Göttingen
Local Institution - 0357
NOT_YET_RECRUITING
Kaiserslautern
VK&K Studien GbR
RECRUITING
Landshut
Gemeinschaftspraxis für Hämatologie und Onkologie
RECRUITING
Langen
Universitatsklinikum Schleswig-Holstein
RECRUITING
Lübeck
RoMed Klinikum Rosenheim
RECRUITING
Rosenheim
Local Institution - 0083
WITHDRAWN
Sindelfingen
Local Institution - 0187
NOT_YET_RECRUITING
Solingen
Fachkliniken Wangen
RECRUITING
Wangen
Local Institution - 0433
NOT_YET_RECRUITING
Wiesbaden
Hungary
Local Institution - 0240
NOT_YET_RECRUITING
Budapest
Local Institution - 0012
NOT_YET_RECRUITING
Farkasgyepű
Mátrai Gyógyintézet
RECRUITING
Gyöngyös
Local Institution - 0241
NOT_YET_RECRUITING
Szolnok
India
Local Institution - 0078
NOT_YET_RECRUITING
Delhi
Local Institution - 0125
NOT_YET_RECRUITING
Dwarka
Local Institution - 0303
NOT_YET_RECRUITING
Eluru
Local Institution - 0427
NOT_YET_RECRUITING
Goraj
Local Institution - 0020
NOT_YET_RECRUITING
Hyderabad
Local Institution - 0015
NOT_YET_RECRUITING
Mumbai
Local Institution - 0219
NOT_YET_RECRUITING
Mumbai
Local Institution - 0008
NOT_YET_RECRUITING
Nagpur
Local Institution - 0036
NOT_YET_RECRUITING
Pune
Local Institution - 0319
NOT_YET_RECRUITING
Visakhapatnam
Italy
Cro-Irccs
RECRUITING
Aviano
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
RECRUITING
Candiolo
Policlinico G. Rodolico
RECRUITING
Catania
AOU di Ferrara Arcispedale S. Anna
RECRUITING
Ferrara (cona)
Local Institution - 0111
NOT_YET_RECRUITING
Genova
Ospedale San Raffaele
RECRUITING
Milan
Istituto Nazionale Tumori IRCCS Fondazione Pascale
RECRUITING
Naples
Azienda Ospedaliero Universitaria Maggiore della Carità
RECRUITING
Novara
Japan
Aomori Prefectural Central Hospital
RECRUITING
Aomori
Funabashi Municipal Medical Center
RECRUITING
Funabashi
Hamamatsu University Hospital
RECRUITING
Hamamatsu
Saitama Medical University International Medical Center
RECRUITING
Hidaka
Kansai Medical University Hospital
RECRUITING
Hirakata-shi
Hiroshima Prefectural Hospital
RECRUITING
Hiroshima
Shonan Kamakura General Hospital
RECRUITING
Kamakura
Ishikawa Prefectural Central Hospital
RECRUITING
Kanazawa
Dokkyo Medical University Saitama Medical Center
RECRUITING
Koshigaya
Saiseikai Kumamoto Hospital
RECRUITING
Kumamoto
Hyogo Medical University Hospital
RECRUITING
Nishinomiya
Kindai University Hospital
RECRUITING
Sakai
Sapporo Minami-Sanjo Hospital
RECRUITING
Sapporo
Local Institution - 0257
NOT_YET_RECRUITING
Sendai
Sendai Kousei Hospital
RECRUITING
Sendai
Local Institution - 0256
NOT_YET_RECRUITING
Tōon
Toyohashi Municipal Hospital
RECRUITING
Toyohashi
Kanagawa cancer center
RECRUITING
Yokohama
Malaysia
Local Institution - 0275
NOT_YET_RECRUITING
George Town
Local Institution - 0277
NOT_YET_RECRUITING
Kuala Lumpur
Local Institution - 0271
NOT_YET_RECRUITING
Kuching
Mexico
Local Institution - 0443
NOT_YET_RECRUITING
Guadalajara
Local Institution - 0075
NOT_YET_RECRUITING
Mexico City
Local Institution - 0385
NOT_YET_RECRUITING
Mexico City
Local Institution - 0386
NOT_YET_RECRUITING
Monterrey
Local Institution - 0097
NOT_YET_RECRUITING
Oaxaca City
Local Institution - 0124
NOT_YET_RECRUITING
Querétaro
Local Institution - 0070
NOT_YET_RECRUITING
Zapopan
Netherlands
Local Institution - 0100
NOT_YET_RECRUITING
's-hertogenbosch
Meander Medisch Centrum
RECRUITING
Amersfoort
Local Institution - 0286
WITHDRAWN
Breda
Local Institution - 0261
WITHDRAWN
Deventer
Radboudumc
RECRUITING
Nijmegen
ETZ Elisabeth
RECRUITING
Tilburg
Norway
Drammen Sykehus, Vestre Viken HF
RECRUITING
Drammen
Østfold Hopsital, Kalnes
RECRUITING
Grålum
Peru
Local Institution - 0155
NOT_YET_RECRUITING
Lima
Local Institution - 0296
NOT_YET_RECRUITING
Lima
Local Institution - 0121
NOT_YET_RECRUITING
San Borja
Poland
Local Institution - 0105
WITHDRAWN
Katowice
Local Institution - 0329
WITHDRAWN
Katowice
Local Institution - 0186
WITHDRAWN
Lodz
Local Institution - 0041
WITHDRAWN
Opole
Local Institution - 0227
WITHDRAWN
Przemyśl
Portugal
Unidade Local de Saúde de Braga
RECRUITING
Braga
Unidade Local de Saúde Santa Maria - Lisboa
RECRUITING
Lisbon
Republic of Korea
Pusan National University Yangsan Hospital
RECRUITING
Busan
Kyungpook National University Chilgok Hospital
RECRUITING
Deagu
Chungnam national university hospital
RECRUITING
Junggu
Konkuk University Medical Center
RECRUITING
Seoul
Romania
Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu
RECRUITING
Baloteşti
Centrul de Diagnostic si Tratament Provita
RECRUITING
Bucharest
Spitalul Clinic Colțea
RECRUITING
Bucharest
Spitalul Universitar de Urgență București
RECRUITING
Bucharest
Institutul Oncologic Cluj
RECRUITING
Cluj-napoca
Centrul de Oncologie Sfântul Nectarie
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
Oncohelp Medical Center
RECRUITING
Timișoara
Singapore
Local Institution - 0269
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
Hospital Universitario de Jaen
RECRUITING
Jaén
Hospital Clinico San Carlos
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Local Institution - 0266
NOT_YET_RECRUITING
Madrid
Hospital Universitario Virgen de la Victoria
RECRUITING
Málaga
Hospital General Universitario Morales Meseguer
RECRUITING
Murcia
Sweden
Local Institution - 0010
NOT_YET_RECRUITING
Gävle
Local Institution - 0039
NOT_YET_RECRUITING
Stockholm
Switzerland
Centre Hospitalier Universitaire Vaudois
RECRUITING
Lausanne
Local Institution - 0053
WITHDRAWN
Sankt Gallen
Onkologiezentrum Thun-Berner Oberland Spital Sts Ag
RECRUITING
Thun
Local Institution - 0262
NOT_YET_RECRUITING
Villars-sur-glâne
Taiwan
E-Da hospital
RECRUITING
Kaohsiung City
Chang Gung Memorial Hospital at Kaohsiung
RECRUITING
Kaohsiung Niao Sung Dist
Far Eastern Memorial Hospital
RECRUITING
New Taipei City
Taichung Veterans General Hospital
RECRUITING
Taichung
Chang Gung Medical Foundation-Linkou Branch
RECRUITING
Taoyuan
Thailand
Local Institution - 0272
NOT_YET_RECRUITING
Bangkok
Local Institution - 0405
NOT_YET_RECRUITING
Chiang Mai
Local Institution - 0273
NOT_YET_RECRUITING
Khon Kaen
Local Institution - 0274
NOT_YET_RECRUITING
Songkhla
Turkey
Local Institution - 0091
NOT_YET_RECRUITING
Adana
Local Institution - 0242
NOT_YET_RECRUITING
Adana
Local Institution - 0415
NOT_YET_RECRUITING
Ankara
Local Institution - 0118
NOT_YET_RECRUITING
Antalya
Local Institution - 0238
NOT_YET_RECRUITING
Çankaya
Local Institution - 0235
NOT_YET_RECRUITING
Cordaleo
Local Institution - 0017
NOT_YET_RECRUITING
Istanbul
Local Institution - 0107
NOT_YET_RECRUITING
Istanbul
Local Institution - 0133
NOT_YET_RECRUITING
Istanbul
Local Institution - 0367
NOT_YET_RECRUITING
Istanbul
Local Institution - 0364
NOT_YET_RECRUITING
Izmir
United Kingdom
Aberdeen Royal Infirmary
RECRUITING
Aberdeen
Addenbrooke's Hospital
RECRUITING
Cambridge
Velindre Cancer Centre
RECRUITING
Cardiff
The Royal Surrey County Hospital NHS Foundation Trust
RECRUITING
Guildford
Royal Marsden Hospital (Chelsea)
RECRUITING
London
Local Institution - 0112
WITHDRAWN
Middlesbrough
Norfolk and Norwich University Hospital
RECRUITING
Norwich
The Royal Marsden NHS Foundation Trust
RECRUITING
Sutton
Royal Wolverhampton Nhs Trust
RECRUITING
Wolverhampton
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: 2026-03-12
Estimated Completion Date: 2031-10-14
Participants
Target number of participants: 750
Treatments
Experimental: Arm A: Pumitamig
Active_comparator: Arm B: Pembrolizumab
Related Therapeutic Areas
Sponsors
Leads: Bristol-Myers Squibb
Collaborators: BioNTech SE