CClinicalTrials.gg
RecruitingNCT07361510Updated Sep 30, 2026

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 interventional study of Pumitamig and Pembrolizumab in Non-Small Cell Lung Cancer (NSCLC), sponsored by Bristol-Myers Squibb. Recruiting at 284 sites in 36 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Bristol-Myers Squibb · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
750
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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%.

02

Conditions studied

  • Non-Small Cell Lung Cancer (NSCLC)

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
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria

  • 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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
750 participants (estimated)

Study arms

  • Experimental
    Arm A: Pumitamig

    Drug: Pumitamig

  • Active comparator
    Arm B: Pembrolizumab

    Drug: Pembrolizumab

Interventions

  • DrugPumitamig

    Specified dose on specified days

    Also known as: BMS-986545

  • DrugPembrolizumab

    Specified dose on specified days

05

What researchers measure

Primary outcomes

  1. Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Time frame: Up to approximately 3 years

  2. Overall survival (OS)

    Time frame: Up to approximately 5 years

Secondary outcomes

  1. PFS by investigator according to RECIST v1.1

    Time frame: Up to approximately 3 years

  2. Objective Response (OR) by BICR according to RECIST v1.1

    Time frame: Up to approximately 3 years

  3. Duration of response (DOR) by BICR according to RECIST v1.1

    Time frame: Up to approximately 3 years

  4. Disease control rate (DCR) by BICR according to RECIST v1.1

    Time frame: Up to approximately 3 years

  5. Time to Response (TTR) by BICR according to RECIST v1.1

    Time frame: Up to approximately 3 years

  6. 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

    Time frame: Up to approximately 3 years

06

Study locations

169 of 284 sites recruiting
  • Southern Cancer Center Pc
    Daphne, Alabama 36526, United States
    • Michael Meshad, Site 0348 · Contact · 111-111-1111
    Recruiting
  • Mohtaseb Cancer Center & Blood Disorders
    Bullhead City, Arizona 86442, United States
    • Hamdy Mohtaseb, Site 0424 · Contact
    Recruiting
  • Palo Verde Hematology Oncology
    Glendale, Arizona 85304, United States
    • Amol Rakkar, Site 0391 · Contact · 602-978-6255
    Recruiting
  • Beverly Hills Cancer Center
    Beverly Hills, California 90211, United States
    • Afshin Gabayan, Site 0352 · Contact · 310-432-8955
    Recruiting
  • Orange Coast Memorial Medical Center
    Fountain Valley, California 92708, United States
    • Amol Rao, Site 0299 · Contact · 510673-1293
    Recruiting
  • Local Institution - 0027
    Los Alamitos, California 90720, United States
    • Site 0027 · Contact
    Not yet recruiting
  • Local Institution - 0422
    Los Angeles, California 90095, United States
    • Site 0422 · Contact
    Not yet recruiting
  • Pacific Cancer Care
    Monterey, California 93940, United States
    • Michael Koontz, Site 0407 · Contact · 831-375-4105
    Recruiting
  • Local Institution - 0403
    Oakland, California 94611, United States
    • Site 0403 · Contact
    Not yet recruiting
  • Local Institution - 0208
    Pleasant Hill, California 94523, United States
    • Site 0208 · Contact
    Not yet recruiting
  • BASS Cancer Center
    Walnut Creek, California 94598, United States
    • Jewel Johl, Site 0416 · Contact · 916-734-3771
    Recruiting
  • Local Institution - 0340
    Lakewood, Colorado 80401, United States
    • Site 0340 · Contact
    Not yet recruiting
  • Clermont Oncology Center
    Clermont, Florida 34711, United States
    • Gopal Kunta, Site 0192 · Contact · 352-242-1366
    Recruiting
  • Advanced Research
    Coral Springs, Florida 33321, United States
    • Sumit Sawhney, Site 0406 · Contact · 954-302-3120
    Recruiting
  • BRP- Hialeah Hospital
    Hialeah, Florida 33013, United States
    • Luis Rangel, Site 0395 · Contact · 833-489-4968
    Recruiting
  • Florida Clinical Trials Group
    Tamarac, Florida 33321, United States
    • Chintan Gandhi, Site 0434 · Contact · 561-447-0614
    Recruiting
  • University Cancer & Blood Center, LLC
    Athens, Georgia 30607, United States
    • Frederick Flynt Jr, Site 0396 · Contact · 706-353-2990
    Recruiting
  • Local Institution - 0412
    Augusta, Georgia 30912, United States
    • Site 0412 · Contact
    Not yet recruiting
  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
    Marietta, Georgia 30060, United States
    • Walid Shaib, Site 0284 · Contact · 770-281-5124
    Recruiting
  • Local Institution - 0423
    Urbana, Illinois 61801, United States
    • Site 0423 · Contact
    Not yet recruiting
  • Northwest Cancer Centers, P.C.
    Dyer, Indiana 46311, United States
    • Shruti Singh, Site 0409 · Contact · 219-924-8178
    Recruiting
  • Missouri Cancer Associates
    Columbia, Missouri 65201, United States
    • Caleb Smith, Site 0350 · Contact
    Recruiting
  • Local Institution - 0224
    Laurelton, New York 11413, United States
    • Site 0224 · Contact
    Not yet recruiting
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
    • Mark Awad, Site 0026 · Contact · 617-632-3468
    Recruiting
  • Optum Medical Care, PC
    Westbury, New York 11590, United States
    • Jonathan Goldberg, Site 0214 · Contact · 914-242-2991
    Recruiting
  • Novant Health Pharmacy Oncology Specialists
    Winston-Salem, North Carolina 27103, United States
    • Garrett Sherwood, Site 0283 · Contact · 336-209-0239
    Recruiting
  • Local Institution - 0383
    Cincinnati, Ohio 45220, United States
    • Site 0383 · Contact
    Not yet recruiting
  • Local Institution - 0418
    Oklahoma City, Oklahoma 73109, United States
    • Site 0418 · Contact
    Not yet recruiting
  • Lancaster General Hospital
    Lancaster, Pennsylvania 17602, United States
    • Samuel Kerr, Site 0288 · Contact · 717-215-9561
    Recruiting
  • Local Institution - 0028
    Pittsburgh, Pennsylvania 15212, United States
    • Site 0028 · Contact
    Not yet recruiting
  • WellSpan Oncology Research
    York, Pennsylvania 17403, United States
    • Ikechukwu Akunyili, Site 0344 · Contact · 717-339-2560
    Recruiting
  • University Of Texas Medical Branch At Galveston
    Galveston, Texas 77555, United States
    • Maurice Willis, Site 0376 · Contact · 409-772-1164
    Recruiting
  • Kelsey-Seybold Clinic Main Campus
    Houston, Texas 77025, United States
    • Sunil Patel, Site 0353 · Contact · 713-442-1700
    Recruiting
  • Texas Oncology - San Antonio
    San Antonio, Texas 78217, United States
    • Krishna Alluri, Site 0351 · Contact · 210-656-7177
    Recruiting
  • Local Institution - 0381
    San Antonio, Texas 78260, United States
    • Site 0381 · Contact
    Not yet recruiting
  • Local Institution - 0337
    Richmond, Virginia 23298, United States
    • Site 0337 · Contact
    Not yet recruiting
  • Shenandoah Oncology, P.C.
    Winchester, Virginia 22601, United States
    • Michael McCusker Jr., Site 0349 · Contact
    Recruiting
  • Local Institution - 0384
    Spokane, Washington 99218, United States
    • Site 0384 · Contact
    Not yet recruiting
  • Charleston Area Medical Center (CAMC)
    Charleston, West Virginia 25304, United States
    • Ahmed Khalid, Site 0339 · Contact
    Recruiting
  • HSHS St. Vincent Hospital Regional Cancer Center
    Green Bay, Wisconsin 54301, United States
    • Brian Burnette, Site 0380 · Contact · 920-884-3135
    Recruiting
  • Local Institution - 0421
    Marshfield, Wisconsin 54449, United States
    • Site 0421 · Contact
    Not yet recruiting
  • Local Institution - 0076
    Mar del Plata, Buenos Aires B7600FZN, Argentina
    • Site 0076 · Contact
    Not yet recruiting
  • Fundacion Estudios Clinicos
    Rosario, Santa Fe Province 2000, Argentina
    • Gabriel Garbaos, Site 0229 · Contact · +5493469699922
    Recruiting
  • Sanatorio Plaza
    Rosario, Santa Fe Province 2000, Argentina
    • Miriam Raimondo, Site 0362 · Contact · +549341644-8821
    Recruiting
  • Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
    San Miguel de Tucumán, Tucumán Province T4000IHE, Argentina
    • Elisa Maria Arroyo, Site 0420 · Contact
    Recruiting
  • Clinica Adventista Belgrano
    Buenos Aires, 1430, Argentina
    • Aldo Perfetti, Site 0058 · Contact · 5491132682903
    Recruiting
  • Hospital Italiano De Cordoba
    Córdoba, X5000BAL, Argentina
    • Virginia Garcia, Site 0374 · Contact · +5493515054293
    Recruiting
  • Gosford Hospital
    Gosford, New South Wales 2250, Australia
    • Matthew Chan, Site 0360 · Contact · +61243209890
    Recruiting
  • Nepean Hospital
    Penrith, New South Wales 2750, Australia
    • Deme Karikios, Site 0176 · Contact · (02) 4734 1751
    Recruiting
  • Lyell McEwin Hospital
    Elizabeth Vale, South Australia 5112, Australia
    • Joanne Tang, Site 0154 · Contact · 08 7117 7265
    Recruiting
  • Grampians Health
    Ballarat Central, Victoria 3350, Australia
    • Wasek Faisal, Site 0221 · Contact · 61(03)53208500
    Recruiting
  • Local Institution - 0201
    Epping, Victoria 3076, Australia
    • Site 0201 · Contact
    Not yet recruiting
  • Joondalup Health Campus
    Joondalup, Western Australia 6027, Australia
    • Arman Hasani, Site 0038 · Contact · +61 8 9400 9897
    Recruiting
  • Kepler Universitaetsklinikum
    Linz, Upper Austria 4021, Austria
    • David Lang, Site 0064 · Contact · 4373278066910
    Recruiting
  • Landeskrankenhaus Feldkirch
    Feldkirch, 6800, Austria
    • Thomas Winder, Site 0196 · Contact · 004355223032681
    Recruiting
  • Universitätsklinikum St. Pölten
    Sankt Pölten, 3100, Austria
    • Martin Wiesholzer, Site 0095 · Contact · 02742900422140
    Recruiting
  • ZAS Augustinus
    Wilrijk, Antwerpen 2610, Belgium
    • Charlotte De Bondt, Site 0188 · Contact · +3232853867
    Recruiting
  • CHIREC - site delta
    Auderghem, Bruxelles-Capitale, Région de 1160, Belgium
    • Christophe Compère, Site 0333 · Contact · 003224348143
    Recruiting
  • UZ Leuven
    Leuven, Vlaams-Brabant 3000, Belgium
    • Els Wauters, Site 0109 · Contact · 3276346826
    Recruiting
  • Algemeen Ziekenhuis klina
    Brasschaat, 2930, Belgium
    • Vincent Geldhof, Site 0345 · Contact · +3234368061
    Recruiting
  • Crio - Centro Regional Integrado de Oncologia
    Fortaleza, Ceará 60336-045, Brazil
    • Eduardo Henrique Cronemberger Costa e Silva, Site 0148 · Contact · +5532613111+55859884
    Recruiting
  • Liga Norte Riograndense Contra o Câncer
    Natal, Rio Grande do Norte 59062-000, Brazil
    • Joilda Rego, Site 0066 · Contact · 558440095595
    Recruiting
  • Hospital São Lucas da PUCRS - Porto Alegre
    Porto Alegre, Rio Grande do Sul 90110-270, Brazil
    • Ana Caroline Gelatti, Site 0245 · Contact · (51)3320-3039
    Recruiting
  • Fundação Pio XII - Hospital de Câncer de Barretos
    Barretos, São Paulo 14784400, Brazil
    • Carlos Baston silva, Site 0085 · Contact · 33216600
    Recruiting
  • A. C. Camargo Cancer Center
    São Paulo, São Paulo 01509-010, Brazil
    • Helano Freitas, Site 0375 · Contact · 5511945544480
    Recruiting
  • Instituto do Cancer Brasil - Taubate
    Taubaté, São Paulo 12030-200, Brazil
    • Luis Eduardo Zucca, Site 0090 · Contact · 551733216638
    Recruiting
  • Centro Paulista de Oncologia Clínica
    São Paulo, 01452-000, Brazil
    • William Nassib William Junior, Site 0163 · Contact · 551135056675
    Recruiting
  • Complex Oncology Center - Ruse EOOD
    Rousse, 7002, Bulgaria
    • Nikolay Nikolaev, Site 0202 · Contact · 0887098616
    Recruiting
  • "Sveta Ekaterina" Hospital
    Sofia, 1431, Bulgaria
    • Galina Kurteva, Site 0326 · Contact · +359887623916
    Recruiting
  • University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna-ISUL" EAD
    Sofia, 1527, Bulgaria
    • Kremena Vasileva, Site 0047 · Contact · +359887123128
    Recruiting
  • Diagnostic and Consultative Center Convex
    Sofia, 1680, Bulgaria
    • Petya Balikova, Site 0325 · Contact · +359 893582321
    Recruiting
  • Bc Cancer Agency
    Prince George, British Columbia V2M7E9, Canada
    • Maria Ho, Site 0411 · Contact · 60498831314934
    Recruiting
  • Local Institution - 0002
    Halifax, Nova Scotia B3H 3A7, Canada
    • Site 0002 · Contact
    Not yet recruiting
  • Local Institution - 0414
    Oshawa, Ontario L1G2B9, Canada
    • Site 0414 · Contact
    Not yet recruiting
  • Local Institution - 0178
    Ottawa, Ontario K1H 8L6, Canada
    • Site 0178 · Contact
    Not yet recruiting
  • Local Institution - 0156
    Toronto, Ontario M6R 1B5, Canada
    • Site 0156 · Contact
    Not yet recruiting
  • Bradford Hill Norte
    Antofagasta, AN 1240000, Chile
    • Angela Estay, Site 0361 · Contact · 56994198125
    Recruiting
  • Centro de Oncología de Precisión
    Las Condes, Arica y Parinacota Region 7560908, Chile
    • Pamela Salman Boghikian, Site 0302 · Contact
    Recruiting
  • Bradfordhill
    Santiago, Santiago Metropolitan 8420383, Chile
    • Carlos Rojas, Site 0199 · Contact · +56998744662
    Recruiting
  • Servicios Medicos e Investigacion Biocenter SpA
    Concepción, 4070196, Chile
    • Jose Barbosa, Site 0293 · Contact
    Recruiting
  • Instituto Nacional del Cancer
    Independencia, 8380455, Chile
    • Ronald Rodriguez, Site 0150 · Contact
    Recruiting
  • Local Institution - 0175
    Beijing, Beijing Municipality 100142, China
    • Site 0175 · Contact
    Not yet recruiting
  • Fujian Cancer Hospital
    Fuzhou, Fujian 350014, China
    • Yunjian Huang, Site 0167 · Contact · 8613805099580
    Recruiting
  • Local Institution - 0141
    Xiamen, Fujian 361003, China
    • Site 0141 · Contact
    Not yet recruiting
  • Zhangzhou Municipal Hospital of Fujian Province
    Zhangzhou, Fujian 363000, China
    • Yuanmao Huang, Site 0327 · Contact · 8617605966308
    Recruiting
  • Nanfang Medical College Nanfang Hospital
    Guangzhou, Guangdong 510515, China
    • Min Shi, Site 0312 · Contact
    Recruiting
  • Cancer Hospital of Shantou University Medical College
    Shantou, Guangdong 515041, China
    • Wen Lin, Site 0210 · Contact · 13612388011
    Recruiting
  • Guangxi Medical University Affiliated Tumor Hospital
    Nanning, Guangxi 530021, China
    • Shaozhang Zhou, Site 0255 · Contact · 8613977183708
    Recruiting
  • Local Institution - 0317
    Harbin, Heilongjiang 150081, China
    • Site 0317 · Contact
    Not yet recruiting
  • Local Institution - 0046
    Zhengzhou, Henan 450008, China
    • Site 0046 · Contact
    Not yet recruiting
  • Local Institution - 0430
    Wuhan, Hubei 430079, China
    • Site 0430 · Contact
    Not yet recruiting
  • Local Institution - 0436
    Xiangyang, Hubei 441021, China
    • Site 0436 · Contact
    Not yet recruiting
  • Local Institution - 0004
    Changsha, Hunan 410013, China
    • Site 0004 · Contact
    Not yet recruiting
  • Local Institution - 0435
    Changsha, Hunan 410013, China
    • Site 0435 · Contact
    Not yet recruiting
  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
    Nanjing, Jiangsu 210000, China
    • Liyun MIAO, Site 0117 · Contact · 13813920964
    Recruiting
  • Jiangsu Cancer Hospital
    Nanjing, Jiangsu 210009, China
    • Guoren Zhou, Site 0316 · Contact · 8613951682839
    Recruiting
  • The Second Affiliated Hospital of Nanchang University
    Nanchang, Jiangxi 330006, China
    • Anwen Liu, Site 0023 · Contact · 8613767120022
    Recruiting
  • Local Institution - 0177
    Shenyang, Liaoning 110042, China
    • Site 0177 · Contact
    Not yet recruiting
  • Local Institution - 0014
    Xi'an, Shaanxi 710038, China
    Withdrawn
  • Local Institution - 0429
    Jinan, Shandong 250013, China
    • Site 0429 · Contact
    Not yet recruiting

Showing the first 100 of 284 sites across 36 countries.

07

References and documents

Individual participant data

Plan to share: 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

Supporting information: Study protocol, Sap, Csr

08

Registry details

Key details

Study ID
NCT07361510
Lead sponsor
Bristol-Myers Squibb
Collaborators
BioNTech SE
Responsible party
Sponsor
First posted
Jan 23, 2026
Start date
Mar 12, 2026
Primary completion
Oct 14, 2031 (estimated)
Completion
Oct 14, 2031 (estimated)
Last update
Sep 30, 2026

Study contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Contact
Clinical.Trials@bms.com
855-907-3286
First line of the email MUST contain NCT # and Site #.
Contact
Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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