NCT07361510Recruiting
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)
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%.
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.
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, Austria, United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Finland, Hungary, India, Japan, Malaysia, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Romania, Singapore, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom
- Sponsor
- Bristol-Myers Squibb(Industry)
- Protocol no.
- CA266-0002
- Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Interventions
- Drug
Treatments studied
- Pumitamig
- Pembrolizumab
Collaborators
BioNTech SE
Locations · 180
- Lausanne, SwitzerlandCentre Hospitalier Universitaire VaudoisRecruiting at this site
- Thun, SwitzerlandOnkologiezentrum Thun-Berner Oberland Spital Sts AgRecruiting at this site
- Nice, FranceCentre Antoine-LacassagneRecruiting at this site
- Pessac, FranceCHU Bordeaux Haut-LevequeRecruiting at this site
- Dijon, FranceCentre Hospitalier Universitaire (CHU) Dijon BourgogneRecruiting at this site
- Limoges, FranceCentre Hospitalier Universitaire de Limoges - Hôpital DupuytrenRecruiting at this site
- Paris, FranceHopitaux Universitaires Paris Centre-Hopital CochinRecruiting at this site
- Quimper, FranceCentre Hospitalier de Cornouaille Quimper - ConcarneauRecruiting at this site
- Reims, FranceInstitut Jean GodinotRecruiting at this site
- Paris, FranceGroupe hospitalier Paris saint JosephRecruiting at this site
- Wangen, GermanyFachkliniken WangenRecruiting at this site
- Landshut, GermanyVK&K Studien GbRRecruiting at this site
- Rosenheim, GermanyRoMed Klinikum RosenheimRecruiting at this site
- Kaiserslautern, GermanyWestpfalz- KlinikumRecruiting at this site
- Langen, GermanyGemeinschaftspraxis für Hämatologie und OnkologieRecruiting at this site
- Dortmund, GermanyGEFOS Society for Oncological StudiesRecruiting at this site
- Lübeck, GermanyUniversitatsklinikum Schleswig-HolsteinRecruiting at this site
- Erfurt, GermanyHELIOS Klinikum ErfurtRecruiting at this site
- Berlin, GermanyHelios Klinikum Emil Von Behring GmbhRecruiting at this site
- Braunschweig, GermanyStaedtisches Klinikum Braunschweig gGmbHRecruiting at this site
- Essen, GermanyKliniken Essen-Mitte/Huyssens-StiftRecruiting at this site
- Gera, GermanySRH Wald-Klinikum Gera GmbHRecruiting at this site
- Ferrara (Cona), ItalyAOU di Ferrara Arcispedale S. AnnaRecruiting at this site
- Aviano, ItalyCro-IrccsRecruiting at this site
- Catania, ItalyPoliclinico "G. Rodolico"Recruiting at this site
- Candiolo, ItalyIstituto di Candiolo IRCCS - Fondazione del Piemonte per l'OncologiaRecruiting at this site
- Genova, ItalyIRCCS AOM Azienda Ospedaliera MetropolitanaRecruiting at this site
- Milan, ItalyOspedale San RaffaeleRecruiting at this site
- Naples, ItalyIstituto Nazionale Tumori IRCCS Fondazione PascaleRecruiting at this site
- Novara, ItalyAzienda Ospedaliero Universitaria Maggiore della CaritàRecruiting at this site
In total, worldwide, 180 of the 283 sites listed in the registry are recruiting; the other 103 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: October 23, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 150 more locations
Other identifiers
- 2025-523586-18 · other identifier
- U1111-1326-9286 · other identifier
- 2025 · NIH grant
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.