Pumitamig compared with durvalumab after chemoradiation for non-small cell lung cancer
Compares pumitamig with durvalumab in adults whose lung cancer cannot be removed surgically.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Bucharest, Cluj-Napoca, Craiova, Floresti, Iasi, Iași, and Timișoara, RomaniaSee the 8 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which best describes your lung cancer?
- Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
Source: NCT07361497, who can take part
Where in Romania
- Centrul De Diagnostic Si Tratament Provita S.A.Bucharest, RomaniaTaking people
- Spitalul Universitar de Urgență BucureștiBucharest, RomaniaTaking people
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-NapocaCluj-Napoca, RomaniaTaking people
- Centrul De Oncologie SF Nectarie S.R.L.Craiova, RomaniaTaking people
- Radiotherapy Center Cluj S.R.L.Floresti, RomaniaTaking people
- Centrul De Oncologie-Euroclinic S.R.L.Iasi, RomaniaTaking people
- Institutul Regional de Oncologie IasiIași, RomaniaTaking people
- Asociatia OncohelpTimișoara, RomaniaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT07361497EU 2025-523576-23-00
- Record updated
- 5 November 2026
- Original description
A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)Read full original descriptionShow less
ROSETTA Lung-201: A Randomized, Multicenter, Open-label Phase 3 Study of Pumitamig Monotherapy Compared to Durvalumab in Participants With Unresectable Stage III NSCLC Without Progression After Platinum-based Concurrent Chemoradiation Therapy.
A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)
Inclusion: 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: 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; Participants must not have an active autoimmune disease; Participants with non-squamous histology must not have documented Epidermal Growth Factor Receptor (EGFR) and anaplastic lymphoma kinase (ALK) rearrangements; Other protocol-defined Inclusion/Exclusion criteria apply.