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Recruiting Phase 3 NCT07361510

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)

Phase 3 – large-scale trial before approval
Conditions: Non-Small Cell Lung Cancer (NSCLC)

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
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%.
Who can participate
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 * 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.
Locations 33
Argentina (1)
Local Institution - 0076
Mar del Plata , Buenos Aires
NOT_YET_RECRUITING
Australia (1)
Local Institution - 0360
Kanwal , New South Wales
NOT_YET_RECRUITING
Belgium (1)
Local Institution - 0345
Brasschaat , Antwerpen
NOT_YET_RECRUITING
Brazil (1)
Local Institution - 0148
Fortaleza , Ceará
NOT_YET_RECRUITING
Bulgaria (1)
Local Institution - 0202
Rousse
NOT_YET_RECRUITING
Canada (1)
Local Institution - 0411
Prince George , British Columbia
NOT_YET_RECRUITING
Chile (1)
Local Institution - 0361
Antofagasta , AN
NOT_YET_RECRUITING
China (1)
Local Institution - 0175
Beijing , Beijing Municipality
NOT_YET_RECRUITING
Colombia (1)
Local Institution - 0310
Rionegro , Antioquia
NOT_YET_RECRUITING
Czech Republic (1)
Local Institution - 0092
Ostrava , Moravian-Silesian
NOT_YET_RECRUITING
Finland (1)
Local Institution - 0060
Kuopio , Northern Savonia
NOT_YET_RECRUITING
France (1)
Local Institution - 0398
Nice , Alpes-Maritimes
NOT_YET_RECRUITING
Germany (1)
Local Institution - 0072
Wangen , Baden-Wurttemberg
NOT_YET_RECRUITING
Hungary (1)
Local Institution - 0240
Budapest
NOT_YET_RECRUITING
India (1)
Local Institution - 0303
Eluru , Andhra Pradesh
NOT_YET_RECRUITING
Italy (1)
Local Institution - 0281
Ferrara (Cona) , Emilia-Romagna
NOT_YET_RECRUITING
Japan (1)
Local Institution - 0055
Toyohashi , Aichi-ken
NOT_YET_RECRUITING
Malaysia (1)
Local Institution - 0275
George Town , Pulau Pinang
NOT_YET_RECRUITING
Mexico (1)
Local Institution - 0070
Zapopan , Jalisco
NOT_YET_RECRUITING
Netherlands (1)
Local Institution - 0110
Nijmegen , Gelderland
NOT_YET_RECRUITING
Norway (1)
Local Institution - 0164
Grålum , Akershus
NOT_YET_RECRUITING
Peru (1)
Local Institution - 0121
San Borja , Lima region
NOT_YET_RECRUITING
Poland (1)
Local Institution - 0227
Przemyśl , Podkarpackie Voivodeship
NOT_YET_RECRUITING
Romania (1)
Local Institution - 0191
Baloteşti , Ilfov
NOT_YET_RECRUITING
Singapore (1)
Local Institution - 0267
Singapore
NOT_YET_RECRUITING
South Korea (1)
Local Institution - 0343
Seoul , Seoul-teukbyeolsi [Seoul]
NOT_YET_RECRUITING
Spain (1)
Local Institution - 0181
Málaga , Málaga
NOT_YET_RECRUITING
Sweden (1)
Local Institution - 0039
Stockholm , Stockholm County
NOT_YET_RECRUITING
Taiwan (1)
Local Institution - 0389
Kaohsuing City , Kaohsiung
NOT_YET_RECRUITING
Thailand (1)
Local Institution - 0272
Bangkok
NOT_YET_RECRUITING
Turkey (1)
Local Institution - 0242
Adana
NOT_YET_RECRUITING
United Kingdom (1)
Local Institution - 0365
Aberdeen , Aberdeenshire
NOT_YET_RECRUITING
United States (1)
Local Institution - 0348
Daphne , Alabama
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
12.03.2026
Completion date
14.10.2031
Registry ID
NCT07361510
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.