Non-Small Cell Lung Cancer (NSCLC)Phase 3NCT07361510
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)
A Phase 3 study testing Pumitamig and Pembrolizumab in people with Non-Small Cell Lung Cancer (NSCLC), run by Bristol-Myers Squibb at 283 sites in 36 countries.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer (NSCLC)
- What is being tested?
- Pumitamig and Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 283 sitesin 36 countries
- Study dates
- 12 Mar 2026to 14 Oct 2031
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants must not have any documented actionable genomic alteration (AGA) for which first-line (1L) approved therapies are indicated.
- Participants must not have any symptomatic untreated central nervous system (CNS) metastases, leptomeningeal metastases (carcinomatous meningitis) or spinal cord compression.
- Participants must not have any significant cardiovascular impairment as evidenced by uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias, or major thrombotic or embolic events or major hemorrhagic events (within 6 months prior to randomization), or significant risk of pulmonary hemorrhage.
- Participants must not an active autoimmune disease.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
283 sites in 36 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
283 sites in 36 countries
United States41 sites, 41 recruiting
- Recruiting
University Cancer & Blood Center, LLC
Athens, Georgia, 30607
Frederick Flynt Jr, Site 0396, 706-353-2990
- Not yet recruiting
Local Institution - 0412
Augusta, Georgia, 30912
Site 0412
- Recruiting
Beverly Hills Cancer Center
Beverly Hills, California, 90211
Afshin Gabayan, Site 0352, 310-432-8955
- Recruiting
Mohtaseb Cancer Center & Blood Disorders
Bullhead City, Arizona, 86442
Hamdy Mohtaseb, Site 0424
- Recruiting
Charleston Area Medical Center (CAMC)
Charleston, West Virginia, 25304
Ahmed Khalid, Site 0339
- Recruiting
Cincinnati Veterans Affairs Medical Center
Cincinnati, Ohio, 45220
Jaskirat Randhawa, Site 0383
- Recruiting
Clermont Oncology Center
Clermont, Florida, 34711
Gopal Kunta, Site 0192, 352-242-1366
- Recruiting
Missouri Cancer Associates
Columbia, Missouri, 65201
Caleb Smith, Site 0350
- Recruiting
Advanced Research
Coral Springs, Florida, 33321
Sumit Sawhney, Site 0406, 954-302-3120
- Recruiting
Southern Cancer Center Pc
Daphne, Alabama, 36526
Michael Meshad, Site 0348, 111-111-1111
- Recruiting
Northwest Cancer Centers, P.C.
Dyer, Indiana, 46311
Shruti Singh, Site 0409, 219-924-8178
- Recruiting
Orange Coast Memorial Medical Center
Fountain Valley, California, 92708
Amol Rao, Site 0299, 510673-1293
- Recruiting
University Of Texas Medical Branch At Galveston
Galveston, Texas, 77555
Maurice Willis, Site 0376, 409-772-1164
- Recruiting
Palo Verde Hematology Oncology
Glendale, Arizona, 85304
Amol Rakkar, Site 0391, 602-978-6255
- Recruiting
HSHS St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54301
Brian Burnette, Site 0380, 920-884-3135
- Recruiting
BRP- Hialeah Hospital
Hialeah, Florida, 33013
Luis Rangel, Site 0395, 833-489-4968
- Recruiting
Kelsey-Seybold Clinic Main Campus
Houston, Texas, 77025
Sunil Patel, Site 0353, 713-442-1700
- Not yet recruiting
Local Institution - 0340
Lakewood, Colorado, 80401
Site 0340
- Recruiting
Lancaster General Hospital
Lancaster, Pennsylvania, 17602
Samuel Kerr, Site 0288, 717-215-9561
- Not yet recruiting
Local Institution - 0224
Laurelton, New York, 11413
Site 0224
- Recruiting
Cancer and Blood Specialty Clinic
Los Alamitos, California, 90720
Nihal Abdulla, Site 0027, 562-706-6648
- Recruiting
UCLA
Los Angeles, California, 90095
Edward Garon, Site 0422, 310-926-5333
- Recruiting
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, 30060
Walid Shaib, Site 0284, 770-281-5124
- Recruiting
Marshfield Medical Center - Marshfield
Marshfield, Wisconsin, 54449
Adedayo Onitilo, Site 0421, 715-393-1454
- Recruiting
Pacific Cancer Care
Monterey, California, 93940
Michael Koontz, Site 0407, 831-375-4105
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Mark Awad, Site 0026, 617-632-3468
- Not yet recruiting
Local Institution - 0403
Oakland, California, 94611
Site 0403
- Not yet recruiting
Local Institution - 0418
Oklahoma City, Oklahoma, 73109
Site 0418
- Not yet recruiting
Local Institution - 0028
Pittsburgh, Pennsylvania, 15212
Site 0028
- Not yet recruiting
Local Institution - 0208
Pleasant Hill, California, 94523
Site 0208
- Not yet recruiting
Local Institution - 0337
Richmond, Virginia, 23298
Site 0337
- Recruiting
Texas Oncology - San Antonio
San Antonio, Texas, 78217
Krishna Alluri, Site 0351, 210-656-7177
- Not yet recruiting
Local Institution - 0381
San Antonio, Texas, 78260
Site 0381
- Not yet recruiting
Local Institution - 0384
Spokane, Washington, 99218
Site 0384
- Recruiting
Florida Clinical Trials Group
Tamarac, Florida, 33321
Chintan Gandhi, Site 0434, 561-447-0614
- Not yet recruiting
Local Institution - 0423
Urbana, Illinois, 61801
Site 0423
- Recruiting
BASS Cancer Center
Walnut Creek, California, 94598
Jewel Johl, Site 0416, 916-734-3771
- Recruiting
Optum Medical Care, PC
Westbury, New York, 11590
Jonathan Goldberg, Site 0214, 914-242-2991
- Recruiting
Shenandoah Oncology, P.C.
Winchester, Virginia, 22601
Michael McCusker Jr., Site 0349
- Recruiting
Novant Health Pharmacy Oncology Specialists
Winston-Salem, North Carolina, 27103
Garrett Sherwood, Site 0283, 336-209-0239
- Recruiting
WellSpan Oncology Research
York, Pennsylvania, 17403
Ikechukwu Akunyili, Site 0344, 717-339-2560
China28 sites, 27 recruiting
- Not yet recruiting
Local Institution - 0175
Beijing, Beijing Municipality, 100142
Site 0175
- Not yet recruiting
Local Institution - 0113
Beijing, 100021
Site 0113
- Not yet recruiting
Local Institution - 0004
Changsha, Hunan, 410013
Site 0004
- Not yet recruiting
Local Institution - 0435
Changsha, Hunan, 410013
Site 0435
- Recruiting
Sichuan Cancer hospital
Chengdu, Sichuan, 610041
Jin Zhou, Site 0246, 18908190355
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Yunjian Huang, Site 0167, 8613805099580
- Recruiting
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, 510515
Min Shi, Site 0312, 13826259986
- Recruiting
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
WEN LI, Site 0089, 13958194313
- Recruiting
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
Enguo Chen, Site 0183, 13588706779
- Not yet recruiting
Local Institution - 0317
Harbin, Heilongjiang, 150081
Site 0317
- Not yet recruiting
Local Institution - 0429
Jinan, Shandong, 250013
Site 0429
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
meng xiangjiao, Site 0359, 13793150996
- Not yet recruiting
Local Institution - 0123
Linyi, Shandong, 276001
Site 0123
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Anwen Liu, Site 0023, 8613767120022
- Recruiting
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210000
Liyun MIAO, Site 0117, 13813920964
- Recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009
Guoren Zhou, Site 0316, 8613951682839
- Recruiting
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530021
Shaozhang Zhou, Site 0255, 8613977183708
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Hua Zhong, Site 0122, 13818200560
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120
Caicun Zhou, Site 0185, 8613301825532
- Recruiting
Fudan University-Zhongshan Hospital
Shanghai Shi, Shanghai Municipality, 201700
Yong Zhang, Site 0212
- Recruiting
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515041
Wen Lin, Site 0210, 13612388011
- Not yet recruiting
Local Institution - 0177
Shenyang, Liaoning, 110042
Site 0177
- Not yet recruiting
Local Institution - 0430
Wuhan, Hubei, 430079
Site 0430
- Withdrawn
Local Institution - 0014
Xi'an, Shaanxi, 710038
- Not yet recruiting
Local Institution - 0141
Xiamen, Fujian, 361003
Site 0141
- Not yet recruiting
Local Institution - 0436
Xiangyang, Hubei, 441021
Site 0436
- Recruiting
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, 363000
Yuanmao Huang, Site 0327, 8617605966308
- Not yet recruiting
Local Institution - 0046
Zhengzhou, Henan, 450008
Site 0046
Japan18 sites, 18 recruiting
- Recruiting
Aomori Prefectural Central Hospital
Aomori, 030-8553
Dai Miura, Site 0363, 017-726-8111
- Recruiting
Funabashi Municipal Medical Center
Funabashi, Chiba, 273-0853
Sukeyuki Nakamura, Site 0258, +81-47-438-3321
- Recruiting
Hamamatsu University Hospital
Hamamatsu, 431-3192
Naoki Inui, Site 0253, 81534352356
- Recruiting
Saitama Medical University International Medical Center
Hidaka, Saitama, 350-1298
Hiroshi Kagamu, Site 0166, 042-984-4111
- Recruiting
Kansai Medical University Hospital
Hirakata-shi, 573-1191
Takayasu Kurata, Site 0252, 81728042503
- Recruiting
Hiroshima Prefectural Hospital
Hiroshima, 734-8530
Nobuhisa Ishikawa, Site 0341, 0822541818
- Recruiting
Shonan Kamakura General Hospital
Kamakura, Kanagawa, 247-8533
Tomoya Fukui, Site 0259, 0467-46-1717
- Recruiting
Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa-ken, 920-8530
Takashi Sone, Site 0056, 81762378211
- Recruiting
Dokkyo Medical University Saitama Medical Center
Koshigaya, Saitama, 3438555
Hiroshige Yoshioka, Site 0247, 048-965-1111
- Recruiting
Saiseikai Kumamoto Hospital
Kumamoto, 861-4193
Kodai Kawamura, Site 0248, +81-96-351-8000
- Recruiting
Hyogo Medical University Hospital
Nishinomiya, Hyōgo, 663-8501
Takashi Kijima, Site 0251, 81798456111
- Recruiting
Kindai University Hospital
Sakai, Osaka, 590-0197
Hidetoshi Hayashi, Site 0250, 81723681184
- Recruiting
Sapporo Minami-Sanjo Hospital
Sapporo, Hokkaido, 060-0063
Toyohiro Saikai, Site 0417, +81112333711
- Recruiting
Tohoku University Hospital
Sendai, Miyagi, 980-8574
Tatsunori Ito, Site 0257, 81227177000
- Recruiting
Sendai Kousei Hospital
Sendai, Miyagi, 9810914
Shunichi Sugawara, Site 0254, 81227288000
- Recruiting
Ehime University Hospital
Tōon, Ehime, 791-0295
Shoichiro Yamamoto, Site 0256, +81-90-2789-2188
- Recruiting
Toyohashi Municipal Hospital
Toyohashi, Aichi-ken, 441-8570
Yasushi Makino, Site 0055, +81-532-33-6111
- Recruiting
Kanagawa cancer center
Yokohama, Kanagawa, 2418515
Shuji Murakami, Site 0249, 81455202222
Germany17 sites, 15 recruiting
- Recruiting
Helios Klinikum Emil Von Behring Gmbh
Berlin, 14165
Daniel Misch, Site 0231, +4930810262287
- Recruiting
Staedtisches Klinikum Braunschweig gGmbH
Braunschweig, 38114
Hendrik Eggers, Site 0158, +4917615323140
- Not yet recruiting
Local Institution - 0432
Cologne, North Rhine-Westphalia, 51109
Site 0432
- Recruiting
GEFOS Society for Oncological Studies
Dortmund, North Rhine-Westphalia, 44263
Daniela Collette, Site 0428
- Recruiting
HELIOS Klinikum Erfurt
Erfurt, Thuringia, 99089
Wolf Brunner, Site 0157
- Recruiting
Kliniken Essen-Mitte/Huyssens-Stift
Essen, 45136
Konstantinos Ferentinos, Site 0073
- Recruiting
SRH Wald-Klinikum Gera GmbH
Gera, 07548
Dagmar Täuscher, Site 0103, 493658287758
- Withdrawn
Local Institution - 0071
Göttingen, 37075
- Recruiting
Westpfalz- Klinikum
Kaiserslautern, Deutschland, 67655
Gerhard Held, Site 0357, +496312031260
- Recruiting
VK&K Studien GbR
Landshut, Bavaria, 84036
Florian Kaiser, Site 0270, +49 871 97403449
- Recruiting
Gemeinschaftspraxis für Hämatologie und Onkologie
Langen, Hesse, 63225
Katharina Girod, Site 0264, +4961033018276
- Recruiting
Universitatsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538
Sabine Bohnet, Site 0172, 4945150045002
- Recruiting
RoMed Klinikum Rosenheim
Rosenheim, Bavaria, 83022
Stephan Budweiser, Site 0024
- Withdrawn
Local Institution - 0083
Sindelfingen, 71065
- Not yet recruiting
Local Institution - 0187
Solingen, North Rhine-Westphalia, 42699
Site 0187
- Recruiting
Fachkliniken Wangen
Wangen, Baden-Wurttemberg, 88239
Philipp Meyn, Site 0072
- Not yet recruiting
Local Institution - 0433
Wiesbaden, Hesse, 65199
Site 0433
France16 sites, 11 recruiting
- Recruiting
Centre Hospitalier Universitaire (CHU) Dijon Bourgogne
Dijon, 21079
Pierre Mouillot, Site 0397, +33 3 80 29 30 31
- Not yet recruiting
Local Institution - 0144
La Tronche, Isère, 38700
Site 0144
- Withdrawn
Local Institution - 0162
Lille, Hauts-de-France, 59037
- Recruiting
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren
Limoges, 87042
Thomas Egenod, Site 0054, 33555056892
- Withdrawn
Local Institution - 0151
Marseille, 13915
- Withdrawn
Local Institution - 0239
Montpellier, Hérault, 34298
- Not yet recruiting
Local Institution - 0447
Montpellier, Occitanie, 34070
Site 0447
- Recruiting
Centre Antoine-Lacassagne
Nice, Alpes-Maritimes, 06189
Victoria ferrari, Site 0398, 0492031324
- Recruiting
Hopitaux Universitaires Paris Centre-Hopital Cochin
Paris, 75679
Marie Wislez, Site 0206, 33158413091
- Recruiting
Groupe hospitalier Paris saint Joseph
Paris, Île-de-France Region, 75014
Nadia Guezour, Site 0207, 330144128510
- Recruiting
CHU Bordeaux Haut-Leveque
Pessac, Aquitaine, 33600
Remi Veillon, Site 0130, 33557656338
- Recruiting
Centre Hospitalier de Cornouaille Quimper - Concarneau
Quimper, 29000
Romain Corre, Site 0390, 33899282481
- Recruiting
Institut Jean Godinot
Reims, 51726
Benoit Godbert, Site 0400, 0646054450
- Withdrawn
Local Institution - 0057
Saint-Herblain, Loire-Atlantique, 44805
- Withdrawn
Local Institution - 0059
Toulouse, Midi-Pyrénées, 31400
- Not yet recruiting
Local Institution - 0445
Villefranche-sur-Saône, Rhone, 69655
Site 0445
Turkey (Türkiye)11 sites, 11 recruiting
- Not yet recruiting
Local Institution - 0242
Adana, 01123
Site 0242
- Not yet recruiting
Local Institution - 0091
Adana, 1370
Site 0091
- Not yet recruiting
Local Institution - 0415
Ankara, 06800
Site 0415
- Not yet recruiting
Local Institution - 0118
Antalya, 07100
Site 0118
- Not yet recruiting
Local Institution - 0238
Çankaya, 06680
Site 0238
- Not yet recruiting
Local Institution - 0235
Cordaleo, 35000
Site 0235
- Not yet recruiting
Local Institution - 0107
Istanbul, 34214
Site 0107
- Not yet recruiting
Local Institution - 0017
Istanbul, 34295
Site 0017
- Not yet recruiting
Local Institution - 0133
Istanbul, 34732
Site 0133
- Not yet recruiting
Local Institution - 0367
Istanbul, 34899
Site 0367
- Not yet recruiting
Local Institution - 0364
Izmir, 35110
Site 0364
Romania10 sites, 10 recruiting
- Recruiting
Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu
Baloteşti, 77015
Cornelia Nitipir, Site 0191
- Recruiting
Centrul de Diagnostic si Tratament Provita
Bucharest, Bucharest, 020335
Mircea Dediu, Site 0044, 0040744432443
- Recruiting
Spitalul Clinic Colțea
Bucharest, 030171
Ileana-Raluca Patru, Site 0049, 40722619891
- Recruiting
Spitalul Universitar de Urgență București
Bucharest, 050098
Georgeta Iorga, Site 0136, 0040721245891
- Recruiting
Institutul Oncologic Cluj
Cluj-Napoca, 400015
Tudor Ciuleanu, Site 0209, 40745646368
- Recruiting
Centrul de Oncologie "Sfântul Nectarie"
Craiova, Dolj, 200542
Michael Schenker, Site 0084, 40727774974
- Recruiting
SC Radiotherapy Center Cluj SRL
Florești, Cluj, 407280
Andrei Ungureanu, Site 0132, 40742206212
- Recruiting
S.C. Centrul de Oncologie Euroclinic S.R.L.
Iași, 700106
Constantin Volovat, Site 0127, 40746110096
- Recruiting
Institutul Regional de Oncologie
Iași, 700483
Dana Clement, Site 0068, 40744692062
- Recruiting
Oncohelp Medical Center
Timișoara, Timiș County, 300239
Daniela Sirbu, Site 0222, 40744571617
India9 sites, 9 recruiting
- Not yet recruiting
Local Institution - 0078
Delhi, 110029
Site 0078
- Not yet recruiting
Local Institution - 0125
Dwarka, National Capital Territory of Delhi, 110075
Site 0125
- Not yet recruiting
Local Institution - 0427
Goraj, Gujarat, 391760
Site 0427
- Not yet recruiting
Local Institution - 0020
Hyderabad, Telangana, 500033
Site 0020
- Not yet recruiting
Local Institution - 0219
Mumbai, Maharashtra, 400012
Site 0219
- Not yet recruiting
Local Institution - 0015
Mumbai, Maharashtra, 400036
Site 0015
- Not yet recruiting
Local Institution - 0008
Nagpur, Maharashtra, 440001
Site 0008
- Not yet recruiting
Local Institution - 0036
Pune, 411001
Site 0036
- Not yet recruiting
Local Institution - 0319
Visakhapatnam, Andhra Pradesh, 530053
Site 0319
Mexico9 sites, 9 recruiting
- Not yet recruiting
Local Institution - 0443
Guadalajara, Jalisco, 44260
Site 0443
- Not yet recruiting
Local Institution - 0075
Mexico City, Mexico City, 04700
Site 0075
- Not yet recruiting
Local Institution - 0449
Mexico City, Mexico City, 11510
Site 0449
- Not yet recruiting
Local Institution - 0385
Mexico City, 14210
Site 0385
- Not yet recruiting
Local Institution - 0386
Monterrey, Nuevo León, 64623
Site 0386
- Not yet recruiting
Local Institution - 0097
Oaxaca City, 68020
Site 0097
- Not yet recruiting
Local Institution - 0450
Puebla City, 72424
Site 0450
- Not yet recruiting
Local Institution - 0124
Querétaro, 76000
Site 0124
- Not yet recruiting
Local Institution - 0070
Zapopan, Jalisco, 45050
Site 0070
Spain9 sites, 9 recruiting
- Recruiting
OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces
Barakaldo, Basque Country, 48903
Xabier Mielgo-Rubio, Site 0074, 0034605751636
- Recruiting
Parc de Salut Mar - Hospital del Mar
Barcelona, Barcelona [Barcelona], 08003
Edurne Arriola Aperribay, Site 0009, +34932483137
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [Cataluña], 08041
Margarita Majem Tarruella, Site 0142, 34935565651
- Recruiting
Hospital Universitario de Jaen
Jaén, 23007
Jose Antonio Lopez Lopez, Site 0099, 34677105057
- Recruiting
Hospital La Princesa
Madrid, 28006
Jacobo Rogado, Site 0266, +34915202200
- Recruiting
Hospital Clinico San Carlos
Madrid, 28040
Carlos Aguado de la Rosa, Site 0021, +34913307552
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Luis Paz-Ares Rodriguez, Site 0179, 0034913908922
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Jose Carlos Benitez Montañez, Site 0181, 34951308130
- Recruiting
Hospital General Universitario Morales Meseguer
Murcia, 30008
Jose Macias Cerrolaza, Site 0263, 0034699638832
United Kingdom9 sites, 8 recruiting
- Recruiting
Aberdeen Royal Infirmary
Aberdeen, Aberdeenshire, AB25 2ZN
Andrew Duncan, Site 0365, 01224 550072
- Recruiting
Addenbrooke's Hospital
Cambridge, CB2 2QQ
Huiqi Yang, Site 0114, 01223 216083
- Recruiting
Velindre Cancer Centre
Cardiff, CF14 2TL
paul shaw, Site 0182, 02920 615888
- Recruiting
The Royal Surrey County Hospital NHS Foundation Trust
Guildford, GU2 7XX
Ajay Mehta, Site 0007, 01483 571122 EX 2627
- Recruiting
Royal Marsden Hospital (Chelsea)
London, SW3 6JJ
Sanjaykumar Popat, Site 0087, 00442078082132
- Withdrawn
Local Institution - 0112
Middlesbrough, Cleveland, TS4 3BW
- Recruiting
Norfolk and Norwich University Hospital
Norwich, East, NR47UY
Farasat Kazmi, Site 0426, 01603 286286
- Recruiting
The Royal Marsden NHS Foundation Trust
Sutton, South East, SM25PT
Sanjaykumar Popat, Site 0410, 0208 186 5267
- Recruiting
Royal Wolverhampton Nhs Trust
Wolverhampton, WV10 0QP
Talha Hafeez, Site 0371, 01902 307999
Italy8 sites, 8 recruiting
- Recruiting
Cro-Irccs
Aviano, Friuli Venezia Giulia, 33081
Alessandra Bearz, Site 0194, 390434659294
- Recruiting
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
Candiolo, Torino, 10060
Vanesa Gregorc, Site 0032, 390119933250
- Recruiting
Policlinico "G. Rodolico"
Catania, Sicily, 95123
HECTOR SOTO PARRA, Site 0279, 0953782426
- Recruiting
AOU di Ferrara Arcispedale S. Anna
Ferrara (Cona), Emilia-Romagna, 44124
Luana Calabrò, Site 0281, 0532239661
- Recruiting
IRCCS AOM Azienda Ospedaliera Metropolitana
Genova, 16132
Carlo Genova, Site 0111, 393397231066
- Recruiting
Ospedale San Raffaele
Milan, 20132
Roberto Ferrara, Site 0033, 390223903829
- Recruiting
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Naples, 80131
Alessandro Morabito, Site 0040, 390817770291
- Recruiting
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, 28100
federica biello, Site 0174, 03213733878
Brazil7 sites, 7 recruiting
- Recruiting
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, 14784400
Carlos Baston silva, Site 0085, 33216600
- Recruiting
Crio - Centro Regional Integrado de Oncologia
Fortaleza, Ceará, 60336-045
Eduardo Henrique Cronemberger Costa e Silva, Site 0148, +5532613111+55859884
- Recruiting
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, 59062-000
Joilda Rego, Site 0066, 558440095595
- Recruiting
Hospital São Lucas da PUCRS - Porto Alegre
Porto Alegre, Rio Grande do Sul, 90110-270
Ana Caroline Gelatti, Site 0245, (51)3320-3039
- Recruiting
A. C. Camargo Cancer Center
São Paulo, São Paulo, 01509-010
Helano Freitas, Site 0375, 5511945544480
- Recruiting
Centro Paulista de Oncologia Clínica
São Paulo, 01452-000
William Nassib William Junior, Site 0163, 551135056675
- Recruiting
Instituto do Cancer Brasil - Taubate
Taubaté, São Paulo, 12030-200
Luis Eduardo Zucca, Site 0090, 551733216638
Argentina6 sites, 6 recruiting
- Recruiting
Clinica Adventista Belgrano
Buenos Aires, 1430
Aldo Perfetti, Site 0058, 5491132682903
- Recruiting
Hospital Italiano De Cordoba
Córdoba, X5000BAL
Virginia Garcia, Site 0374, +5493515054293
- Recruiting
Investigaciones Oncologicas C Colon SA
Mar del Plata, Buenos Aires, 7600
Ignacio Casarini, Site 0076, +5492235937663
- Recruiting
Fundacion Estudios Clinicos
Rosario, Santa Fe Province, 2000
Gabriel Garbaos, Site 0229, +5493469699922
- Recruiting
Sanatorio Plaza
Rosario, Santa Fe Province, 2000
Miriam Raimondo, Site 0362, +549341644-8821
- Recruiting
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
San Miguel de Tucumán, Tucumán Province, T4000IHE
Elisa Maria Arroyo, Site 0420
Australia6 sites, 6 recruiting
- Recruiting
Grampians Health
Ballarat Central, Victoria, 3350
Wasek Faisal, Site 0221, 61(03)53208500
- Recruiting
Lyell McEwin Hospital
Elizabeth Vale, South Australia, 5112
Joanne Tang, Site 0154, 08 7117 7265
- Not yet recruiting
Local Institution - 0201
Epping, Victoria, 3076
Site 0201
- Recruiting
Gosford Hospital
Gosford, New South Wales, 2250
Matthew Chan, Site 0360, +61243209890
- Recruiting
Joondalup Health Campus
Joondalup, Western Australia, 6027
Arman Hasani, Site 0038, +61 8 9400 9897
- Recruiting
Nepean Hospital
Penrith, New South Wales, 2750
Deme Karikios, Site 0176, (02) 4734 1751
Netherlands6 sites, 4 recruiting
- Not yet recruiting
Local Institution - 0100
's-Hertogenbosch, 5211 NL
Site 0100
- Recruiting
Meander Medisch Centrum
Amersfoort, 3813 TZ
Judith Herder, Site 0161, 0031338507843
- Withdrawn
Local Institution - 0286
Breda, North Brabant, 4818 CK
- Withdrawn
Local Institution - 0261
Deventer, 7400 GC
- Recruiting
Radboudumc
Nijmegen, Gelderland, 6525 GA
Wouter van Geffen, Site 0110, (024)3638114
- Recruiting
ETZ Elisabeth
Tilburg, 5022 GC
Brian de Bruijn, Site 0094, 0132216969
Canada5 sites, 5 recruiting
- Not yet recruiting
Local Institution - 0002
Halifax, Nova Scotia, B3H 3A7
Site 0002
- Not yet recruiting
Local Institution - 0414
Oshawa, Ontario, L1G2B9
Site 0414
- Not yet recruiting
Local Institution - 0178
Ottawa, Ontario, K1H 8L6
Site 0178
- Recruiting
Bc Cancer Agency
Prince George, British Columbia, V2M7E9
Maria Ho, Site 0411, 60498831314934
- Not yet recruiting
Local Institution - 0156
Toronto, Ontario, M6R 1B5
Site 0156
Chile5 sites, 5 recruiting
- Recruiting
Bradford Hill Norte
Antofagasta, AN, 1240000
Angela Estay, Site 0361, 56994198125
- Recruiting
Servicios Medicos e Investigacion Biocenter SpA
Concepción, 4070196
Jose Barbosa, Site 0293
- Recruiting
Instituto Nacional del Cancer
Independencia, 8380455
Ronald Rodriguez, Site 0150
- Recruiting
Centro de Oncología de Precisión
Las Condes, Arica y Parinacota Region, 7560908
Pamela Salman Boghikian, Site 0302
- Recruiting
Bradfordhill
Santiago, Santiago Metropolitan, 8420383
Carlos Rojas, Site 0199, +56998744662
Colombia5 sites, 5 recruiting
- Not yet recruiting
Local Institution - 0328
Barranquilla, Atlántico, 80020
Site 0328
- Not yet recruiting
Local Institution - 0441
Bogotá, Bogota Capital District, 111221
Site 0441
- Not yet recruiting
Local Institution - 0218
Bogotá
Site 0218
- Not yet recruiting
Local Institution - 0307
Medellín, 050034
Site 0307
- Not yet recruiting
Local Institution - 0310
Rionegro, Antioquia, 054047
Site 0310
Poland5 sites
- Withdrawn
Local Institution - 0105
Katowice, 40-514
- Withdrawn
Local Institution - 0329
Katowice, 40-519
- Withdrawn
Local Institution - 0186
Lodz, 93-338
- Withdrawn
Local Institution - 0041
Opole, Opole Voivodeship, 45-061
- Withdrawn
Local Institution - 0227
Przemyśl, Podkarpackie Voivodeship, 37-700
Taiwan5 sites, 5 recruiting
- Recruiting
E-Da hospital
Kaohsiung City, 82445
Yu-Feng Wei, Site 0387, +88676150011ext.5056
- Recruiting
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, Kaohsiung, 83301
Kuo-Tung Huang, Site 0389, 886773171238199
- Recruiting
Far Eastern Memorial Hospital
New Taipei City, 220
Cheng-Yu Chang, Site 0035, 886289667000ext.1815
- Recruiting
Taichung Veterans General Hospital
Taichung, 407
Tsung-Ying Yang, Site 0203, 8864235925253218
- Recruiting
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
Cheng-Ta Yang, Site 0388, 886332812008468
Belgium4 sites, 4 recruiting
- Recruiting
CHIREC - site delta
Auderghem, Bruxelles-Capitale, Région de, 1160
Christophe Compère, Site 0333, 003224348143
- Recruiting
Algemeen Ziekenhuis klina
Brasschaat, 2930
Vincent Geldhof, Site 0345, +3234368061
- Recruiting
UZ Leuven
Leuven, Vlaams-Brabant, 3000
Els Wauters, Site 0109, 3276346826
- Recruiting
ZAS Augustinus
Wilrijk, Antwerpen, 2610
Charlotte De Bondt, Site 0188, +3232853867
Bulgaria4 sites, 4 recruiting
- Recruiting
Complex Oncology Center - Ruse EOOD
Rousse, 7002
Nikolay Nikolaev, Site 0202, 0887098616
- Recruiting
"Sveta Ekaterina" Hospital
Sofia, 1431
Galina Kurteva, Site 0326, +359887623916
- Recruiting
University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna-ISUL" EAD
Sofia, 1527
Kremena Vasileva, Site 0047, +359887123128
- Recruiting
Diagnostic and Consultative Center Convex
Sofia, 1680
Petya Balikova, Site 0325, +359 893582321
Czechia4 sites, 4 recruiting
- Recruiting
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05
Michal Hrnciarik, Site 0243, +420495834780
- Recruiting
Fakultni nemocnice Olomouc
Olomouc, 779 00
Juraj Kultan, Site 0236, 420588445657
- Recruiting
Nemocnice AGEL Ostrava - Vitkovice a.s.
Ostrava, Ostrava Město, 703 84
Jaromir Roubec, Site 0092, 00420595633400
- Not yet recruiting
Local Institution - 0129
Pilsen, Plzeň Region, 305 99
Site 0129
Hungary4 sites, 4 recruiting
- Not yet recruiting
Local Institution - 0240
Budapest, 1121
Site 0240
- Recruiting
Farkasgyepui Tudogyogyintezet
Farkasgyepű, Veszprém megye, 8582
Zsolt Kiraly, Site 0012, 36209264476
- Recruiting
Mátrai Gyógyintézet
Gyöngyös, 3200
Istvan Albert, Site 0244, 36202708215
- Not yet recruiting
Local Institution - 0241
Szolnok, 5004
Site 0241
South Korea4 sites, 4 recruiting
- Recruiting
Pusan National University Yangsan Hospital
Busan, Kyǒngsangnam-do, 50612
Seong Hoon Yoon, Site 0342, 82-10-2870-9389
- Recruiting
Kyungpook National University Chilgok Hospital
Deagu, Taegu-Kwangyǒkshi, 41404
Shin Yup Lee, Site 0336, 82-10-6516-1694
- Recruiting
Chungnam national university hospital
Junggu, Taejǒn-Kwangyǒkshi, 35015
Jeong Eun Lee, Site 0335
- Recruiting
Konkuk University Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 05030
Hee Joung Kim, Site 0343, 82220307525
Switzerland4 sites, 3 recruiting
- Recruiting
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011
Nuria-Neisy Mederos-Alfonso, Site 0399, 41213140193
- Withdrawn
Local Institution - 0053
Sankt Gallen, 9007
- Recruiting
Onkologiezentrum Thun-Berner Oberland Spital Sts Ag
Thun, 3600
Christoph Ackermann, Site 0019, +41 58 636 22 27
- Not yet recruiting
Local Institution - 0262
Villars-sur-Glâne, 1752
Site 0262
Thailand4 sites, 4 recruiting
- Not yet recruiting
Local Institution - 0272
Bangkok, 10700
Site 0272
- Not yet recruiting
Local Institution - 0405
Chiang Mai, 50200
Site 0405
- Not yet recruiting
Local Institution - 0273
Khon Kaen, 40002
Site 0273
- Not yet recruiting
Local Institution - 0274
Songkhla, 90110
Site 0274
Austria3 sites, 3 recruiting
- Recruiting
Landeskrankenhaus Feldkirch
Feldkirch, 6800
Thomas Winder, Site 0196, 004355223032681
- Recruiting
Kepler Universitaetsklinikum
Linz, Upper Austria, 4021
David Lang, Site 0064, 4373278066910
- Recruiting
Universitätsklinikum St. Pölten
Sankt Pölten, 3100
Martin Wiesholzer, Site 0095, 02742900422140
Finland3 sites, 3 recruiting
- Recruiting
Kuopion Yliopistollinen Sairaala
Kuopio, Northern Savonia, 70200
Okko Kaariainen, Site 0060, 358 17 173311
- Recruiting
Tampereen yliopistollinen sairaala
Tampere, 33521
Jarkko Ahvonen, Site 0171, 358 3 311611.
- Recruiting
Vaasan Keskussairaala
Vaasa, 65130
Antti Jekunen, Site 0126, 358 6 2181111
Malaysia3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0275
George Town, Pulau Pinang, 10990
Site 0275
- Not yet recruiting
Local Institution - 0277
Kuala Lumpur, 50603
Site 0277
- Not yet recruiting
Local Institution - 0271
Kuching, Sarawak, 93586
Site 0271
Peru3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0155
Lima, 27
Site 0155
- Not yet recruiting
Local Institution - 0296
Lima, Lima 41
Site 0296
- Not yet recruiting
Local Institution - 0121
San Borja, Lima region, 15034
Site 0121
Norway2 sites, 2 recruiting
- Recruiting
Drammen Sykehus, Vestre Viken HF
Drammen, Buskerud, 3004
Inger Johanne Eide, Site 0050, 4732000240
- Recruiting
Østfold Hopsital, Kalnes
Grålum, Akershus, 1714
Johanne Dypvik, Site 0164
Portugal2 sites, 2 recruiting
- Recruiting
Unidade Local de Saúde de Braga
Braga, 4710-243
Ana Daniela Marques, Site 0294, +351916940855
- Recruiting
Unidade Local de Saúde Santa Maria - Lisboa
Lisbon, 1769-001
Ana Sofia Vilarica, Site 0278
Singapore2 sites, 2 recruiting
- Recruiting
National Cancer Centre Singapore
Singapore, 168583
Yi Lin Teh, Site 0267, 6564368000
- Not yet recruiting
Local Institution - 0269
Singapore, 308442
Site 0269
Sweden2 sites, 2 recruiting
- Not yet recruiting
Local Institution - 0010
Gävle, 801 87
Site 0010
- Not yet recruiting
Local Institution - 0039
Stockholm, Stockholm County, 17176
Site 0039
About this study
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%.
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%.
- Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Being tested
- Pumitamig, Pembrolizumab
- Keywords
- Non-Small Cell Lung Cancer (NSCLC), 1L NSCLC, Programmed death ligand-1 (PD-L1), Frst line NSCLC, Advanced NSCLC, Metastatic NSCLC, Pumitamig, Pembrolizumab, ROSETTA LUNG-202, ROSETTA LUNG, CA2660002
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PumitamigDrug
Also called BMS-986545
Specified dose on specified days
PembrolizumabDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Pumitamig | Experimental | Not described Receives: Drug: Pumitamig |
| Arm B: Pembrolizumab | Active comparator | Not described Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: Up to approximately 3 years
Overall survival (OS)
Measured: Up to approximately 5 years
Secondary outcomes (6)
PFS by investigator according to RECIST v1.1
Measured: Up to approximately 3 years
Objective Response (OR) by BICR according to RECIST v1.1
Measured: Up to approximately 3 years
Duration of response (DOR) by BICR according to RECIST v1.1
Measured: Up to approximately 3 years
Disease control rate (DCR) by BICR according to RECIST v1.1
Measured: Up to approximately 3 years
Time to Response (TTR) by BICR according to RECIST v1.1
Measured: Up to approximately 3 years
Time to definitive deterioration (TTDD) based on the Non-Small Cell Lung Cancer-Symptom Assessment Questionnaire (NSCLC-SAQ) defined as the time from randomization until a definitive clinically meaningful worsening in symptoms or in NSCLC-SAQ total score
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start12 Mar 2026
- Primary completion14 Oct 2031 (estimated)
- Study completion14 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioNTech SE
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361510
- Sponsor's protocol ID
- CA266-0002
- Other IDs
- 2025-523586-18, U1111-1326-9286, 2025
- Status last verified
- Oct 2026
- First submitted
- 21 Jan 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html