NCT07361497Recruiting
A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201)
Summary
A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)
Inclusion criteria
• Participants must have a histologically- or cytologically-confirmed diagnoses of non-small cell lung cancer (NSCLC) with unresectable Stage III disease. • Participants must have received at least 2 cycles of platinum-based concurrent chemoradiotherapy (a total dose of radiation of at least 54 Gy). • Participants must have no progressive disease (PD) following treatment with concurrent chemoradiotherapy (CCRT). • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
Exclusion criteria
• Participants with non-squamous histology must not have documented Epidermal Growth Factor Receptor (EGFR) and anaplastic lymphoma kinase (ALK) rearrangements. • Participants must not have an active autoimmune disease. • Participants must not have significant cardiovascular impairment such as uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias, major thrombotic or embolic events or major hemorrhagic events within 6 months prior to randomization, or significant risk of pulmonary hemorrhage. • Participants must not have advanced/clinically significant lung disease (within 6 months prior to randomization) or history of interstitial lung disease (ILD) or pneumonitis requiring treatment with systemic steroids (≥ Grade 2), or current or suspected ILD or pneumonitis. • Participants must not have any prior anticancer therapy (outside of CCRT) for locally advanced Stage III 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, Greece, Hong Kong, Hungary, India, Ireland, Japan, Mexico, Netherlands, Poland, Romania, Singapore, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom
- Sponsor
- Bristol-Myers Squibb(Industry)
- Protocol no.
- CA266-0001
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Interventions
- Drug
Treatments studied
- Pumitamig
- Durvalumab
Collaborators
BioNTech SE
Locations · 192
- Basel, SwitzerlandUniversitaetsspital BaselRecruiting at this site
- Bellinzona, SwitzerlandOspedale Regionale Bellinzona e ValliRecruiting at this site
- Münsterlingen, SwitzerlandKantonsspital Münsterlingen - Spital Thurgau AGRecruiting at this site
- Sankt Gallen, SwitzerlandKantonsspital St GallenRecruiting at this site
- Bordeaux, FranceInstitut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud OuestRecruiting at this site
- Lyon Cedex08, FranceCentre Leon BerardRecruiting at this site
- Montpellier, FranceInstitut Régional du Cancer MontpellierRecruiting at this site
- Saint-Herblain, FranceHôpital Nord Guillaume-et-René-Laennec / CHU de NantesRecruiting at this site
- Toulouse, FranceCHU de Toulouse - Hopital LarreyRecruiting at this site
- Lille, FranceCHU Lille - Institut Coeur PoumonRecruiting at this site
- Limoges, FranceCentre Hospitalier Universitaire de Limoges - Hôpital DupuytrenRecruiting at this site
- Marseille, FranceAssistance Publique Hôpitaux de Marseille - Hôpital NordRecruiting at this site
- Paris, FranceHopitaux Universitaires Paris Centre-Hopital CochinRecruiting at this site
- Augsburg, GermanyKlinikum AugsburgRecruiting at this site
- Koblenz, GermanyKatholisches Klinikum-Koblenz MarienhofRecruiting at this site
- Ludwigshafen am Rhein, GermanyKlinikum der Stadt Ludwigshafen gGmbHRecruiting at this site
- Kiel, GermanyUniversitatsklinikum Schleswig-HolsteinRecruiting at this site
- Jena, GermanyUniversitaetsklinikum JenaRecruiting at this site
- Gröbenzell, GermanyAsklepios Fachkliniken Muenchen-GautingRecruiting at this site
- Haile, GermanyKrankenhaus Martha-Maria Halle-Doelau GgmbhRecruiting at this site
- Hamburg, GermanyLungenClinic Grosshansdorf GmbHRecruiting at this site
- Immenhausen, GermanyLungenfachklinik ImmenhausenRecruiting at this site
- Regensburg, GermanyUniversitaetsklinikum RegensburgRecruiting at this site
- Naples, ItalyIstituto Nazionale Tumori IRCCS Fondazione PascaleRecruiting at this site
- Ravenna, ItalyOspedale Santa Maria delle CrociRecruiting at this site
- Aviano, ItalyCro-IrccsRecruiting at this site
- Orbassano, ItalyAzienda Ospedaliero-Universitaria San Luigi GonzagaRecruiting at this site
- Rome, ItalyPoliclinico Universitario Campus Bio-MedicoRecruiting at this site
- Milan, ItalyOspedale San RaffaeleRecruiting at this site
- Milan, ItalyIstituto Europeo di Oncologia IRCCSRecruiting at this site
In total, worldwide, 192 of the 260 sites listed in the registry are recruiting; the other 68 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: September 30, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 162 more locations
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.