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A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202)
Sponsor: Bristol-Myers Squibb
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%.
Official title: 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%.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
750
Start Date
2026-03-12
Completion Date
2031-10-14
Last Updated
2026-06-26
Healthy Volunteers
No
Conditions
Interventions
Pumitamig
Specified dose on specified days
Pembrolizumab
Specified dose on specified days
Locations (272)
Southern Cancer Center Pc
Daphne, Alabama, United States
Mohtaseb Cancer Center & Blood Disorders
Bullhead City, Arizona, United States
Palo Verde Hematology Oncology
Glendale, Arizona, United States
Local Institution - 0407
Anaheim, California, United States
Local Institution - 0352
Beverly Hills, California, United States
Orange Coast Memorial Medical Center
Fountain Valley, California, United States
Local Institution - 0027
Los Alamitos, California, United States
Local Institution - 0422
Los Angeles, California, United States
Local Institution - 0403
Oakland, California, United States
Local Institution - 0208
Pleasant Hill, California, United States
Local Institution - 0416
Walnut Creek, California, United States
Local Institution - 0340
Lakewood, Colorado, United States
Clermont Oncology Center
Clermont, Florida, United States
Advanced Research
Coral Springs, Florida, United States
BRP- Hialeah Hospital
Hialeah, Florida, United States
University Cancer & Blood Center, LLC
Athens, Georgia, United States
Local Institution - 0412
Augusta, Georgia, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, United States
Local Institution - 0423
Urbana, Illinois, United States
Northwest Cancer Centers, P.C.
Dyer, Indiana, United States
Missouri Cancer Associates
Columbia, Missouri, United States
Local Institution - 0224
Laurelton, New York, United States
Local Institution - 0026
New York, New York, United States
Local Institution - 0214
Westbury, New York, United States
Local Institution - 0283
Winston-Salem, North Carolina, United States
Local Institution - 0383
Cincinnati, Ohio, United States
Local Institution - 0418
Oklahoma City, Oklahoma, United States
Local Institution - 0288
Lancaster, Pennsylvania, United States
Local Institution - 0028
Pittsburgh, Pennsylvania, United States
WellSpan Oncology Research
York, Pennsylvania, United States
Local Institution - 0376
Galveston, Texas, United States
Kelsey-Seybold Clinic Main Campus
Houston, Texas, United States
Texas Oncology - San Antonio
San Antonio, Texas, United States
Local Institution - 0381
San Antonio, Texas, United States
Local Institution - 0337
Richmond, Virginia, United States
Shenandoah Oncology, P.C.
Winchester, Virginia, United States
Local Institution - 0384
Spokane, Washington, United States
Local Institution - 0339
Charleston, West Virginia, United States
HSHS St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
Local Institution - 0421
Marshfield, Wisconsin, United States
Local Institution - 0076
Mar del Plata, Buenos Aires, Argentina
Local Institution - 0229
Rosario, Santa Fe Province, Argentina
Sanatorio Plaza
Rosario, Santa Fe Province, Argentina
Local Institution - 0420
San Miguel de Tucumán, Tucumán Province, Argentina
Local Institution - 0058
Buenos Aires, Argentina
Local Institution - 0374
Córdoba, Argentina
Gosford Hospital
Gosford, New South Wales, Australia
Local Institution - 0176
Penrith, New South Wales, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
Local Institution - 0201
Epping, Victoria, Australia
Grampians Health
Mount Waverley, Victoria, Australia
Joondalup Health Campus
Joondalup, Western Australia, Australia
Kepler Universitaetsklinikum
Linz, Upper Austria, Austria
Local Institution - 0196
Feldkirch, Austria
Local Institution - 0095
Sankt Pölten, Austria
Local Institution - 0345
Brasschaat, Antwerpen, Belgium
Local Institution - 0333
Auderghem, Bruxelles-Capitale, Région de, Belgium
Local Institution - 0109
Leuven, Vlaams-Brabant, Belgium
Local Institution - 0188
Edegem, Belgium
Local Institution - 0148
Fortaleza, Ceará, Brazil
Local Institution - 0066
Natal/RN, Rio Grande do Norte, Brazil
Local Institution - 0245
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0085
Barretos, São Paulo, Brazil
Local Institution - 0375
São Paulo, São Paulo, Brazil
Local Institution - 0090
Taubaté, São Paulo, Brazil
Local Institution - 0163
São Paulo, Brazil
Complex Oncology Center - Ruse EOOD
Rousse, Bulgaria
Local Institution - 0326
Sofia, Bulgaria
Local Institution - 0047
Sofia, Bulgaria
Local Institution - 0325
Sofia, Bulgaria
Local Institution - 0411
Prince George, British Columbia, Canada
Local Institution - 0002
Halifax, Nova Scotia, Canada
Local Institution - 0414
Oshawa, Ontario, Canada
Local Institution - 0178
Ottawa, Ontario, Canada
Local Institution - 0156
Toronto, Ontario, Canada
Local Institution - 0361
Antofagasta, AN, Chile
Local Institution - 0302
Las Condes, Arica y Parinacota Region, Chile
Local Institution - 0199
Santiago, Santiago Metropolitan, Chile
Local Institution - 0293
Concepción, Chile
Local Institution - 0150
Independencia, Chile
Local Institution - 0175
Beijing, Beijing Municipality, China
Local Institution - 0167
Fuzhou, Fujian, China
Local Institution - 0141
Xiamen, Fujian, China
Local Institution - 0327
Zhangzhou, Fujian, China
Local Institution - 0312
Guangzhou, Guangdong, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, China
Local Institution - 0317
Harbin, Heilongjiang, China
Local Institution - 0046
Zhengzhou, Henan, China
Local Institution - 0004
Changsha, Hunan, China
Local Institution - 0117
Nanjing, Jiangsu, China
Local Institution - 0316
Nanjing, Jiangsu, China
Local Institution - 0023
Nanchang, Jiangxi, China
Local Institution - 0177
Shenyang, Liaoning, China
Local Institution - 0014
Xi'an, Shaanxi, China
Shandong Cancer Hospital
Jinan, Shandong, China
Local Institution - 0123
Linyi, Shandong, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Local Institution - 0212
Shanghai Shi, Shanghai Municipality, China
Local Institution - 0246
Chengdu, Sichuan, China
Local Institution - 0183
Hangzhou, Zhejiang, China
Local Institution - 0089
Hangzhou, Zhejiang, China
Local Institution - 0113
Beijing, China
Local Institution - 0122
Shanghai Shi, China
Local Institution - 0310
Rionegro, Antioquia, Colombia
Local Institution - 0328
Barranquilla, Atlántico, Colombia
Local Institution - 0218
Bogotá, Colombia
Local Institution - 0307
Medellín, Colombia
Local Institution - 0092
Ostrava, Moravian-Silesian, Czechia
Local Institution - 0129
Pilsen, Plzeň Region, Czechia
Local Institution - 0243
Hradec Králové, Czechia
Local Institution - 0236
Olomouc, Czechia
Local Institution - 0060
Kuopio, Northern Savonia, Finland
Tampereen yliopistollinen sairaala
Tampere, Finland
Vaasan Keskussairaala
Vaasa, Finland
Local Institution - 0398
Nice, Alpes-Maritimes, France
CHU Bordeaux Haut-Leveque
Pessac, Aquitaine, France
Local Institution - 0162
Lille, Hauts-de-France, France
Local Institution - 0239
Montpellier, Hérault, France
Local Institution - 0144
La Tronche, Isère, France
Local Institution - 0057
Saint-Herblain, Loire-Atlantique, France
Local Institution - 0059
Toulouse, Midi-Pyrénées, France
Local Institution - 0397
Dijon, France
Local Institution - 0054
Limoges, France
Local Institution - 0151
Marseille, France
Hopitaux Universitaires Paris Centre-Hopital Cochin
Paris, France
Centre Hospitalier de Cornouaille Quimper - Concarneau
Quimper, France
Institut Jean Godinot
Reims, France
Local Institution - 0207
Paris, Île-de-France Region, France
Fachkliniken Wangen
Wangen, Baden-Wurttemberg, Germany
Local Institution - 0270
Landshut, Bavaria, Germany
Local Institution - 0024
Rosenheim, Bavaria, Germany
Local Institution - 0357
Kaiserslautern, Deutschland, Germany
Gemeinschaftspraxis für Hämatologie und Onkologie
Langen, Hesse, Germany
Local Institution - 0432
Cologne, North Rhine-Westphalia, Germany
Local Institution - 0428
Dortmund, North Rhine-Westphalia, Germany
Local Institution - 0187
Solingen, North Rhine-Westphalia, Germany
Local Institution - 0172
Kiel, Schleswig-Holstein, Germany
Local Institution - 0231
Berlin, Germany
Local Institution - 0158
Braunschweig, Germany
Local Institution - 0157
Erfurt, Germany
Local Institution - 0073
Essen, Germany
Local Institution - 0103
Gera, Germany
Local Institution - 0071
Göttingen, Germany
Local Institution - 0083
Sindelfingen, Germany
Local Institution - 0240
Budapest, Hungary
Local Institution - 0012
Farkasgyepű, Hungary
Local Institution - 0244
Mátraháza, Hungary
Local Institution - 0241
Szolnok, Hungary
Local Institution - 0303
Eluru, Andhra Pradesh, India
Local Institution - 0319
Visakhapatnam, Andhra Pradesh, India
Local Institution - 0427
Goraj, Gujarat, India
Local Institution - 0219
Mumbai, Maharashtra, India
Local Institution - 0015
Mumbai, Maharashtra, India
Local Institution - 0008
Nagpur, Maharashtra, India
Local Institution - 0125
Dwarka, National Capital Territory of Delhi, India
Local Institution - 0020
Hyderabad, Telangana, India
Local Institution - 0078
Delhi, India
Local Institution - 0036
Pune, India
AOU di Ferrara Arcispedale S. Anna
Ferrara (Cona), Emilia-Romagna, Italy
Cro-Irccs
Aviano, Friuli Venezia Giulia, Italy
Local Institution - 0279
Catania, Sicily, Italy
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
Candiolo, Torino, Italy
Local Institution - 0111
Genova, Italy
Local Institution - 0033
Milan, Italy
Local Institution - 0040
Naples, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, Italy
Toyohashi Municipal Hospital
Toyohashi, Aichi-ken, Japan
Local Institution - 0363
Aomori, Aomori, Japan
Funabashi Municipal Medical Center
Funabashi, Chiba, Japan
Local Institution - 0256
Tōon, Ehime, Japan
Local Institution - 0417
Sapporo, Hokkaido, Japan
Hyogo Medical University Hospital
Nishinomiya, Hyōgo, Japan
Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa-ken, Japan
Shonan Kamakura General Hospital
Kamakura, Kanagawa, Japan
Kanagawa cancer center
Yokohama, Kanagawa, Japan
Local Institution - 0257
Sendai, Miyagi, Japan
Sendai Kousei Hospital
Sendai, Miyagi, Japan
Kindai University Hospital
Sakai, Osaka, Japan
Local Institution - 0247
Koshigaya, Saitama, Japan
Local Institution - 0166
Hidaka, Saitama-Pref, Japan
Hamamatsu University Hospital
Hamamatsu, Japan
Local Institution - 0252
Hirakata-shi, Japan
Hiroshima Prefectural Hospital
Hiroshima, Japan
Saiseikai Kumamoto Hospital
Kumamoto, Japan
Local Institution - 0275
George Town, Pulau Pinang, Malaysia
Local Institution - 0271
Kuching, Sarawak, Malaysia
Local Institution - 0277
Kuala Lumpur, Malaysia
Local Institution - 0070
Zapopan, Jalisco, Mexico
Local Institution - 0075
Mexico City, Mexico City, Mexico
Local Institution - 0386
Monterrey, Nuevo León, Mexico
Local Institution - 0385
Mexico City, Mexico
Local Institution - 0097
Oaxaca City, Mexico
Local Institution - 0124
Querétaro, Mexico
Local Institution - 0110
Nijmegen, Gelderland, Netherlands
Local Institution - 0286
Breda, North Brabant, Netherlands
Local Institution - 0100
's-Hertogenbosch, Netherlands
Meander Medisch Centrum
Amersfoort, Netherlands
Local Institution - 0261
Deventer, Netherlands
Local Institution - 0094
Tilburg, Netherlands
Østfold Hopsital, Kalnes
Grålum, Akershus, Norway
Drammen Sykehus, Vestre Viken HF
Drammen, Buskerud, Norway
Local Institution - 0121
San Borja, Lima region, Peru
Local Institution - 0155
Lima, Peru
Local Institution - 0296
Lima, Peru
Local Institution - 0041
Opole, Opole Voivodeship, Poland
Local Institution - 0227
Przemyśl, Podkarpackie Voivodeship, Poland
Local Institution - 0105
Katowice, Poland
Local Institution - 0329
Katowice, Poland
Local Institution - 0186
Lodz, Poland
Local Institution - 0294
Braga, Portugal
Local Institution - 0278
Lisbon, Portugal
Centrul de Diagnostic si Tratament Provita
Bucharest, Bucharest, Romania
Centrul de Oncologie "Sfântul Nectarie"
Craiova, Dolj, Romania
Oncohelp Medical Center
Timișoara, Timiș County, Romania
Local Institution - 0191
Baloteşti, Romania
Local Institution - 0049
Bucharest, Romania
Local Institution - 0136
Bucharest, Romania
Institutul Oncologic Cluj
Cluj-Napoca, Romania
Local Institution - 0132
Floresti/ Cluj, Romania
Local Institution - 0127
Iași, Romania
Local Institution - 0068
Iași, Romania
Local Institution - 0267
Singapore, Singapore
Local Institution - 0269
Singapore, Singapore
Pusan National University Yangsan Hospital
Busan, Kyǒngsangnam-do, South Korea
Konkuk University Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Kyungpook National University Chilgok Hospital
Deagu, Taegu-Kwangyǒkshi, South Korea
Chungnam national university hospital
Junggu, Taejǒn-Kwangyǒkshi, South Korea
OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces
Barakaldo, Basque Country, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [Cataluña], Spain
Local Institution - 0009
Barcelona, Spain
Hospital Universitario de Jaen
Jaén, Spain
Local Institution - 0266
Madrid, Spain
Local Institution - 0021
Madrid, Spain
Local Institution - 0179
Madrid, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Hospital General Universitario Morales Meseguer
Murcia, Spain
Local Institution - 0039
Stockholm, Stockholm County, Sweden
Local Institution - 0010
Gävle, Sweden
Local Institution - 0399
Lausanne, Switzerland
Local Institution - 0053
Sankt Gallen, Switzerland
Local Institution - 0019
Thun, Switzerland
Local Institution - 0262
Villars-sur-Glâne, Switzerland
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Local Institution - 0387
Kaohsiung City, Taiwan
Far Eastern Memorial Hospital
New Taipei City, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, Taiwan
Local Institution - 0272
Bangkok, Thailand
Local Institution - 0405
Chiang Mai, Thailand
Local Institution - 0273
Khon Kaen, Thailand
Local Institution - 0274
Songkhla, Thailand
Local Institution - 0242
Adana, Turkey (Türkiye)
Local Institution - 0091
Adana, Turkey (Türkiye)
Local Institution - 0415
Ankara, Turkey (Türkiye)
Local Institution - 0118
Antalya, Turkey (Türkiye)
Local Institution - 0235
Cordaleo, Turkey (Türkiye)
Local Institution - 0238
Çankaya, Turkey (Türkiye)
Local Institution - 0107
Istanbul, Turkey (Türkiye)
Local Institution - 0017
Istanbul, Turkey (Türkiye)
Local Institution - 0133
Istanbul, Turkey (Türkiye)
Local Institution - 0367
Istanbul, Turkey (Türkiye)
Local Institution - 0364
Izmir, Turkey (Türkiye)
Local Institution - 0365
Aberdeen, Aberdeenshire, United Kingdom
Local Institution - 0112
Middlesbrough, Cleveland, United Kingdom
Local Institution - 0426
Norwich, East, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, South East, United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom
Velindre Cancer Centre
Cardiff, United Kingdom
Local Institution - 0007
Guildford, United Kingdom
Royal Marsden Hospital (Chelsea)
London, United Kingdom
Royal Wolverhampton Nhs Trust
Wolverhampton, United Kingdom