CA266-0001: ROSETTA Lung-201: Phase 3 NSCLC study
Research type
Research Study
Full title
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
IRAS ID
1013502
Contact name
GSM-CT Representative
Contact email
Sponsor organisation
Bristol-Myers Squibb Services Unlimited Company
Eudract number
2025-523576-23
Clinicaltrials.gov Identifier
Research summary
ROSETTA Lung‑201 (CA266‑0001) is a global clinical study researching how well a medicine called pumitamig works compared with durvalumab in people with unresectable stage III non–small cell lung cancer (NSCLC) who have received at least two cycles of chemoradiation. The study will look at how well the cancer responds to treatment (efficacy) and how long people live (survival).\n\nPumitamig is designed to support the immune system in recognising and attacking cancer cells. It also blocks the growth of blood vessels that help tumours develop. Early studies suggest pumitamig can be given safely and may have potential benefits in lung cancer.\n\nThis Phase 3 study includes four parts:\n1. Screening – checks to confirm eligibility.\n2. Treatment – participants are randomly assigned to one of two groups:\n - Arm A: pumitamig, given by intravenous infusion every 3 weeks\n - Arm B: durvalumab, given every 4 weeks\n Treatment continues until one of the following: a maximum of 1 year of treatment, cancer progression, side effects becoming too severe, withdrawal of consent, confirmed pregnancy, or early study closure.\n3. Safety Follow‑up – participants are monitored for side effects for around 90 days after treatment stops.\n4. Survival Follow‑up – participants are contacted approximately every 12 weeks to check how they are doing.\n\nThe expected total study duration for each participant is around 7.5 years.\n\nAbout 850 people will take part worldwide, including participants in the UK. The study is funded by Bristol Myers Squibb (BMS) and will take place in hospitals and cancer centres across several countries. The results may help improve future treatment options for people with locally advanced lung cancer.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
26/EE/0032
Date of REC Opinion
2 Apr 2026
REC opinion
Further Information Favourable Opinion