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)
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%.
3 other identifiers
interventional
750
35 countries
268
Brief 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%.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2026
Longer than P75 for phase_3
268 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2026
CompletedFirst Posted
Study publicly available on registry
January 23, 2026
CompletedStudy Start
First participant enrolled
March 12, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 14, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 14, 2031
April 15, 2026
April 1, 2026
5.6 years
January 21, 2026
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Up to approximately 3 years
Overall survival (OS)
Up to approximately 5 years
Secondary Outcomes (6)
PFS by investigator according to RECIST v1.1
Up to approximately 3 years
Objective Response (OR) by BICR according to RECIST v1.1
Up to approximately 3 years
Duration of response (DOR) by BICR according to RECIST v1.1
Up to approximately 3 years
Disease control rate (DCR) by BICR according to RECIST v1.1
Up to approximately 3 years
Time to Response (TTR) by BICR according to RECIST v1.1
Up to approximately 3 years
- +1 more secondary outcomes
Study Arms (2)
Arm A: Pumitamig
EXPERIMENTALArm B: Pembrolizumab
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- BioNTech SEcollaborator
Study Sites (271)
Local Institution - 0348
Daphne, Alabama, 36526, United States
Local Institution - 0424
Bullhead City, Arizona, 86442, United States
Local Institution - 0391
Glendale, Arizona, 85304, United States
Local Institution - 0407
Anaheim, California, 92801, United States
Local Institution - 0352
Beverly Hills, California, 90211, United States
Orange Coast Memorial Medical Center
Fountain Valley, California, 92708, United States
Local Institution - 0027
Los Alamitos, California, 90720, United States
Local Institution - 0422
Los Angeles, California, 90095, United States
Local Institution - 0403
Oakland, California, 94611, United States
Local Institution - 0208
Pleasant Hill, California, 94523, United States
Local Institution - 0416
Walnut Creek, California, 94598, United States
Local Institution - 0340
Lakewood, Colorado, 80401, United States
Clermont Oncology Center
Clermont, Florida, 34711, United States
BRP- Hialeah Hospital
Hialeah, Florida, 33013, United States
Local Institution - 0406
Pompano Beach, Florida, 33064, United States
Local Institution - 0396
Athens, Georgia, 30607, United States
Local Institution - 0412
Augusta, Georgia, 30912, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, 30060, United States
Local Institution - 0423
Urbana, Illinois, 61801, United States
Missouri Cancer Associates
Columbia, Missouri, 65201, United States
Local Institution - 0224
Laurelton, New York, 11413, United States
Local Institution - 0026
New York, New York, 10021, United States
Local Institution - 0214
Westbury, New York, 11590, United States
Local Institution - 0283
Winston-Salem, North Carolina, 27103, United States
Local Institution - 0383
Cincinnati, Ohio, 45220, United States
Local Institution - 0418
Oklahoma City, Oklahoma, 73109, United States
Local Institution - 0288
Lancaster, Pennsylvania, 17601, United States
Local Institution - 0028
Pittsburgh, Pennsylvania, 15212, United States
WellSpan Oncology Research
York, Pennsylvania, 17403, United States
Local Institution - 0376
Galveston, Texas, 77555, United States
Local Institution - 0353
Houston, Texas, 77025, United States
Local Institution - 0409
Houston, Texas, 77090, United States
Texas Oncology - San Antonio
San Antonio, Texas, 78217, United States
Local Institution - 0381
San Antonio, Texas, 78260, United States
Local Institution - 0337
Richmond, Virginia, 23298, United States
Shenandoah Oncology, P.C.
Winchester, Virginia, 22601, United States
Local Institution - 0384
Spokane, Washington, 99218, United States
Local Institution - 0339
Charleston, West Virginia, 25304, United States
Local Institution - 0380
Green Bay, Wisconsin, 54301, United States
Local Institution - 0421
Marshfield, Wisconsin, 54449, United States
Local Institution - 0076
Mar del Plata, Buenos Aires, B7600FZN, Argentina
Local Institution - 0229
Rosario, Santa Fe Province, 2000, Argentina
Local Institution - 0362
Rosario, Santa Fe Province, 2000, Argentina
Local Institution - 0420
San Miguel de Tucumán, Tucumán Province, T4000IHE, Argentina
Local Institution - 0058
Buenos Aires, 1430, Argentina
Local Institution - 0374
Córdoba, X5000BAL, Argentina
Local Institution - 0360
Kanwal, New South Wales, 2259, Australia
Local Institution - 0176
Penrith, New South Wales, 2750, Australia
Local Institution - 0154
Elizabeth Vale, South Australia, 5112, Australia
Local Institution - 0221
Ballarat, Victoria, 3350, Australia
Local Institution - 0201
Epping, Victoria, 3076, Australia
Local Institution - 0038
Joondalup, Western Australia, 6027, Australia
Local Institution - 0064
Linz, Upper Austria, 4021, Austria
Local Institution - 0196
Feldkirch, 6800, Austria
Local Institution - 0095
Sankt Pölten, 3100, Austria
Local Institution - 0345
Brasschaat, Antwerpen, 2930, Belgium
Local Institution - 0333
Auderghem, Bruxelles-Capitale, Région de, 1160, Belgium
Local Institution - 0109
Leuven, Vlaams-Brabant, 3000, Belgium
Local Institution - 0188
Edegem, 2650, Belgium
Local Institution - 0148
Fortaleza, Ceará, 60336-045, Brazil
Local Institution - 0066
Natal/RN, Rio Grande do Norte, 59062-000, Brazil
Local Institution - 0245
Porto Alegre, Rio Grande do Sul, 90110-270, Brazil
Local Institution - 0085
Barretos, São Paulo, 14784, Brazil
Local Institution - 0375
São Paulo, São Paulo, 01509-010, Brazil
Local Institution - 0090
Taubaté, São Paulo, 12030-200, Brazil
Local Institution - 0163
São Paulo, 01452-000, Brazil
Local Institution - 0202
Rousse, 7002, Bulgaria
Local Institution - 0326
Sofia, 1431, Bulgaria
Local Institution - 0047
Sofia, 1527, Bulgaria
Local Institution - 0325
Sofia, 1680, Bulgaria
Local Institution - 0411
Prince George, British Columbia, V2M7E9, Canada
Local Institution - 0413
Fredericton, New Brunswick, E3B4R3, Canada
Local Institution - 0002
Halifax, Nova Scotia, B3H 3A7, Canada
Local Institution - 0414
Oshawa, Ontario, L1G2B9, Canada
Local Institution - 0178
Ottawa, Ontario, K1H 8L6, Canada
Local Institution - 0156
Toronto, Ontario, M6R 1B5, Canada
Local Institution - 0361
Antofagasta, AN, 1240000, Chile
Local Institution - 0302
Las Condes, Arica y Parinacota Region, 7560908, Chile
Local Institution - 0419
Las Condes, Santiago Metropolitan, 7580206, Chile
Local Institution - 0222
Santiago, Santiago Metropolitan, 7510032, Chile
Local Institution - 0199
Santiago, Santiago Metropolitan, 8420383, Chile
Local Institution - 0293
Concepción, 4070196, Chile
Local Institution - 0150
Independencia, 8380455, Chile
Local Institution - 0175
Beijing, Beijing Municipality, 100142, China
Local Institution - 0167
Fuzhou, Fujian, 350014, China
Local Institution - 0141
Xiamen, Fujian, 361003, China
Local Institution - 0327
Zhangzhou, Fujian, 363000, China
Local Institution - 0312
Guangzhou, Guangdong, 510515, China
Local Institution - 0210
Shantou, Guangdong, 515031, China
Local Institution - 0255
Nanning, Guangxi, 530021, China
Local Institution - 0317
Harbin, Heilongjiang, 150081, China
Local Institution - 0004
Changsha, Hunan, 410013, China
Local Institution - 0117
Nanjing, Jiangsu, 210000, China
Local Institution - 0316
Nanjing, Jiangsu, 210009, China
Local Institution - 0023
Nanchang, Jiangxi, 330006, China
Local Institution - 0177
Shenyang, Liaoning, 110042, China
Local Institution - 0014
Xi'an, Shaanxi, 710038, China
Local Institution - 0359
Jinan, Shandong, 250117, China
Local Institution - 0123
Linyi, Shandong, 276001, China
Local Institution - 0185
Shanghai, Shanghai Municipality, 200120, China
Local Institution - 0212
Shanghai Shi, Shanghai Municipality, 201700, China
Local Institution - 0246
Chengdu, Sichuan, 610041, China
Local Institution - 0183
Hangzhou, Zhejiang, 310016, China
Local Institution - 0089
Hangzhou, Zhejiang, 310052, China
Local Institution - 0113
Beijing, 100021, China
Local Institution - 0122
Shanghai Shi, 200030, China
Local Institution - 0046
Zhengzhou, 450008, China
Local Institution - 0310
Rionegro, Antioquia, 054047, Colombia
Local Institution - 0328
Barranquilla, Atlántico, 80020, Colombia
Local Institution - 0218
Bogotá, Colombia
Local Institution - 0307
Medellín, 050034, Colombia
Local Institution - 0092
Ostrava, Moravian-Silesian, 70384, Czechia
Local Institution - 0129
Pilsen, Plzeň Region, 305 99, Czechia
Local Institution - 0243
Hradec Králové, 500 05, Czechia
Local Institution - 0236
Olomouc, 77520, Czechia
Local Institution - 0060
Kuopio, Northern Savonia, 70200, Finland
Local Institution - 0171
Tampere, 33521, Finland
Local Institution - 0126
Vaasa, 65130, Finland
Local Institution - 0398
Nice, Alpes-Maritimes, 06189, France
Local Institution - 0130
Pessac, Aquitaine, 33600, France
Local Institution - 0162
Lille, Hauts-de-France, 59037, France
Local Institution - 0239
Montpellier, Hérault, 34298, France
Local Institution - 0144
La Tronche, Isère, 38700, France
Local Institution - 0057
Saint-Herblain, Loire-Atlantique, 44805, France
Local Institution - 0059
Toulouse, Midi-Pyrénées, 31400, France
Local Institution - 0397
Dijon, 21079, France
Local Institution - 0054
Limoges, 87042, France
Local Institution - 0151
Marseille, 13915, France
Local Institution - 0206
Paris, 75679, France
Local Institution - 0390
Quimper, 29000, France
Local Institution - 0400
Reims, 51726, France
Local Institution - 0207
Paris, Île-de-France Region, 75014, France
Local Institution - 0072
Wangen, Baden-Wurttemberg, 88239, Germany
Local Institution - 0270
Landshut, Bavaria, 84036, Germany
Local Institution - 0024
Rosenheim, Bavaria, 83022, Germany
Local Institution - 0187
Solingen, North Rhine-Westphalia, 42699, Germany
Local Institution - 0172
Kiel, Schleswig-Holstein, 24105, Germany
Local Institution - 0231
Berlin, 14165, Germany
Local Institution - 0158
Braunschweig, 38114, Germany
Local Institution - 0157
Erfurt, 99089, Germany
Local Institution - 0073
Essen, 45136, Germany
Local Institution - 0103
Gera, 07548, Germany
Local Institution - 0071
Göttingen, 37075, Germany
Local Institution - 0357
Kaiserslautern, 67655, Germany
Local Institution - 0264
Münster, 48149, Germany
Local Institution - 0083
Sindelfingen, 71065, Germany
Local Institution - 0240
Budapest, 1121, Hungary
Local Institution - 0234
Budapest, 1122, Hungary
Local Institution - 0012
Farkasgyepű, 8582, Hungary
Local Institution - 0244
Mátraháza, 3233, Hungary
Local Institution - 0241
Szolnok, 5004, Hungary
Local Institution - 0303
Eluru, Andhra Pradesh, 534002, India
Local Institution - 0319
Visakhapatnam, Andhra Pradesh, 530053, India
Local Institution - 0219
Mumbai, Maharashtra, 400012, India
Local Institution - 0015
Mumbai, Maharashtra, 400036, India
Local Institution - 0008
Nagpur, Maharashtra, 440001, India
Local Institution - 0125
Dwarka, National Capital Territory of Delhi, 110075, India
Local Institution - 0020
Hyderabad, Telangana, 500033, India
Local Institution - 0078
Delhi, 110029, India
Local Institution - 0036
Pune, 411001, India
Local Institution - 0281
Ferrara (Cona), Emilia-Romagna, 44124, Italy
Local Institution - 0174
Novara, Piedmont, 28100, Italy
Local Institution - 0279
Catania, Sicily, 95123, Italy
Local Institution - 0194
Aviano (PN), 33081, Italy
Local Institution - 0032
Candiolo, 10060, Italy
Local Institution - 0111
Genova, 16132, Italy
Local Institution - 0033
Milan, 20132, Italy
Local Institution - 0040
Naples, 80131, Italy
Local Institution - 0055
Toyohashi, Aichi-ken, 441-8570, Japan
Local Institution - 0363
Aomori, Aomori, 0308553, Japan
Local Institution - 0258
Funabashi, Chiba, 273-0853, Japan
Local Institution - 0256
Tōon, Ehime, 791-0295, Japan
Local Institution - 0417
Sapporo, Hokkaido, 060-0063, Japan
Local Institution - 0251
Nishinomiya-shi, Hyōgo, 6638501, Japan
Local Institution - 0056
Kanazawa, Ishikawa-ken, 920-8530, Japan
Local Institution - 0259
Kamakura, Kanagawa, 247-8533, Japan
Local Institution - 0248
Kumamoto, Kumamoto, 861-4193, Japan
Local Institution - 0254
Sendai, Miyagi, 980-0873, Japan
Local Institution - 0257
Sendai, Miyagi, 980-8574, Japan
Local Institution - 0250
Osakasayama-shi, Osaka, 5898511, Japan
Local Institution - 0247
Koshigaya, Saitama, 343-0845, Japan
Local Institution - 0166
Hidaka, Saitama-Pref, 350-1298, Japan
Local Institution - 0253
Hamamatsu, 431-3192, Japan
Local Institution - 0252
Hirakata-shi, 573-1191, Japan
Local Institution - 0341
Hiroshima, 734-8530, Japan
Local Institution - 0249
Yokohama, 101-0047, Japan
Local Institution - 0275
George Town, Pulau Pinang, 10990, Malaysia
Local Institution - 0271
Kuching, Sarawak, 93586, Malaysia
Local Institution - 0277
Kuala Lumpur, 50603, Malaysia
Local Institution - 0070
Zapopan, Jalisco, 45050, Mexico
Local Institution - 0075
Mexico City, Mexico City, 04700, Mexico
Local Institution - 0386
Monterrey, Nuevo León, 64623, Mexico
Local Institution - 0385
Mexico City, 14210, Mexico
Local Institution - 0097
Oaxaca City, 68020, Mexico
Local Institution - 0124
Querétaro, 76000, Mexico
Local Institution - 0110
Nijmegen, Gelderland, 6525 GA, Netherlands
Local Institution - 0286
Breda, North Brabant, 4818 CK, Netherlands
Local Institution - 0100
's-Hertogenbosch, 5211 NL, Netherlands
Local Institution - 0161
Amersfoort, 3813 TZ, Netherlands
Local Institution - 0261
Deventer, 7400 GC, Netherlands
Local Institution - 0094
Tilburg, 5022 GC, Netherlands
Local Institution - 0164
Grålum, Akershus, 1714, Norway
Local Institution - 0050
Drammen, Buskerud, 3004, Norway
Local Institution - 0121
San Borja, Lima region, 15034, Peru
Local Institution - 0155
Lima, 27, Peru
Local Institution - 0296
Lima, Lima 41, Peru
Local Institution - 0227
Przemyśl, Podkarpackie Voivodeship, 37-700, Poland
Local Institution - 0329
Katowice, 40-519, Poland
Local Institution - 0186
Lodz, 93-338, Poland
Local Institution - 0041
Opole, 45-372, Poland
Local Institution - 0105
Warsaw, 02-616, Poland
Local Institution - 0294
Braga, 4710-243, Portugal
Local Institution - 0278
Lisbon, 1769-001, Portugal
Local Institution - 0191
Baloteşti, Ilfov, 77015, Romania
Local Institution - 0044
Bucharest, 020335, Romania
Local Institution - 0049
Bucharest, 030171, Romania
Local Institution - 0136
Bucharest, 050098, Romania
Local Institution - 0209
Cluj-Napoca, 400015, Romania
Local Institution - 0084
Craiova, 200347, Romania
Local Institution - 0132
Floresti/ Cluj, 407280, Romania
Local Institution - 0127
Iași, 700106, Romania
Local Institution - 0068
Iași, 700483, Romania
Local Institution - 0267
Singapore, 169610, Singapore
Local Institution - 0269
Singapore, 308442, Singapore
Local Institution - 0343
Seoul, Seoul-teukbyeolsi [Seoul], 05030, South Korea
Local Institution - 0336
Deagu, Taegu-Kwangyǒkshi, 41404, South Korea
Local Institution - 0335
Junggu, Taejǒn-Kwangyǒkshi, 35015, South Korea
Local Institution - 0342
Yangsan, 50612, South Korea
Local Institution - 0181
Málaga, Málaga, 29010, Spain
Local Institution - 0074
Barakaldo, 48903, Spain
Local Institution - 0009
Barcelona, 08003, Spain
Local Institution - 0142
Barcelona, 08041, Spain
Local Institution - 0099
Jaén, 23007, Spain
Local Institution - 0266
Madrid, 28006, Spain
Local Institution - 0021
Madrid, 28040, Spain
Local Institution - 0179
Madrid, 28041, Spain
Local Institution - 0263
Murcia, 30008, Spain
Local Institution - 0039
Stockholm, Stockholm County, 17176, Sweden
Local Institution - 0010
Gävle, 801 87, Sweden
Local Institution - 0399
Lausanne, 1011, Switzerland
Local Institution - 0053
Sankt Gallen, 9007, Switzerland
Local Institution - 0019
Thun, 3600, Switzerland
Local Institution - 0262
Villars-sur-Glâne, 1752, Switzerland
Local Institution - 0389
Kaohsuing City, Kaohsiung, 83301, Taiwan
Local Institution - 0388
Taoyuan, Taoyuan, 33378, Taiwan
Local Institution - 0203
Chiayi City, 60090, Taiwan
Local Institution - 0387
Kaohsiung City, 82445, Taiwan
Local Institution - 0035
New Taipei City, 220, Taiwan
Local Institution - 0272
Bangkok, 10700, Thailand
Local Institution - 0405
Chiang Mai, 50200, Thailand
Local Institution - 0273
Khon Kaen, 40002, Thailand
Local Institution - 0274
Songkhla, 90110, Thailand
Local Institution - 0242
Adana, 01123, Turkey (Türkiye)
Local Institution - 0091
Adana, 1370, Turkey (Türkiye)
Local Institution - 0415
Ankara, 06800, Turkey (Türkiye)
Local Institution - 0118
Antalya, 7050, Turkey (Türkiye)
Local Institution - 0235
Cordaleo, 35000, Turkey (Türkiye)
Local Institution - 0238
Çankaya, 06680, Turkey (Türkiye)
Local Institution - 0107
Istanbul, 34214, Turkey (Türkiye)
Local Institution - 0017
Istanbul, 34295, Turkey (Türkiye)
Local Institution - 0133
Istanbul, 34732, Turkey (Türkiye)
Local Institution - 0367
Istanbul, 34899, Turkey (Türkiye)
Local Institution - 0364
Izmir, 35110, Turkey (Türkiye)
Local Institution - 0365
Aberdeen, Aberdeenshire, AB25 2ZN, United Kingdom
Local Institution - 0112
Middlesbrough, Cleveland, TS4 3BW, United Kingdom
Local Institution - 0410
Sutton, South East, SM25PT, United Kingdom
Local Institution - 0114
Cambridge, CB2 2QQ, United Kingdom
Local Institution - 0182
Cardiff, CF14 2TL, United Kingdom
Local Institution - 0007
Guildford, GU2 7XX, United Kingdom
Local Institution - 0087
London, SW3 6JJ, United Kingdom
Local Institution - 0371
Wolverhampton, WV10 0QP, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Central Study Contacts
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
First line of the email MUST contain NCT # and Site #.
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2026
First Posted
January 23, 2026
Study Start
March 12, 2026
Primary Completion (Estimated)
October 14, 2031
Study Completion (Estimated)
October 14, 2031
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See Plan Description
- Access Criteria
- See Plan Description
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