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)

StatusRecruiting

PhasePhase 3

SponsorBristol-Myers Squibb

Started2026-03-12

View on ClinicalTrials.gov ↗

Amendment history

2026-09-04

Study Status, Contacts/Locations v10

Trial sites expanded: 279 → 284 locations

2026-08-07

Study Status, Contacts/Locations v9

Trial sites expanded: 274 → 278 locations

2026-07-17

Study Status, Contacts/Locations v8

Study sites272→274

2026-06-25

Study Status, Contacts/Locations v7

Study sites273→272

2026-06-02

Study Status, Contacts/Locations v6

Study sites272→273

2026-05-12

Study Status, Contacts/Locations v5

Study sites271→272

2026-04-14

Study Status, Contacts/Locations v4

Trial sites expanded: 267 → 271 locations

2026-03-24

Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3

Trial statusNot Yet Recruiting→Recruiting

Start dateestimated 2026-04-09→confirmed 2026-03-12

Study sites254→267

2026-02-17

Study Status, Contacts/Locations, IPDSharing v2

Study sites250→254

2026-01-27

Study Status, Conditions, Contacts/Locations, References v1

Study sites238→250

2026-01-21

Original filing

Bristol-Myers Squibb

311 trials monitored

See 15 trials at risk

Lung Cancer

4,033 trials monitored

See 210 trials at risk

Non-Small Cell Lung Cancer (NSCLC)

2,914 trials monitored

See 156 trials at risk

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%.

Trial Details

NCT Number	NCT07361510
Lead Sponsor	Bristol-Myers Squibb Collaborators: BioNTech SE
Conditions	Non-Small Cell Lung Cancer (NSCLC)
Enrollment	750 participants
Start Date	2026-03-12
Primary Completion	2031-10-14 (estimated)
Study Completion	2031-10-14 (estimated)
Updated on ClinicalTrials.gov	2026-09-30