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)
← catalyst calendarNCT07361510 · readout in 1,882 d
Sponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →. With BioNTech SE.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
750estimated
Sites
278
Countries
Argentina, Australia, Austria +33
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-03-12 | actual | When the study began enrolling |
| Primary completion | 2031-10-14 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2031-10-14 | estimated | The whole study's end, after follow-up |
| First posted | 2026-01-23 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-10 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Non-Small Cell Lung Cancer (NSCLC)
Interventions
- Drug: Pumitamig — also filed as BMS-986545
- Drug: Pembrolizumab
Primary outcomes
what the primary-completion date above is the date OFProgression-free Survival (PFS) by Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
measured Up to approximately 3 years
Overall survival (OS)
measured Up to approximately 5 years
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