NCT07361510 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)
| NCT ID | NCT07361510 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Bristol-Myers Squibb |
| Condition | Non-Small Cell Lung Cancer (NSCLC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 750 participants |
| Start Date | 2026-03-12 |
| Primary Completion | 2031-10-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 750 participants in total. It began in 2026-03-12 with a primary completion date of 2031-10-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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%.
Eligibility Criteria
Inclusion Criteria * Participants must have a histologically or cytologically confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC) (squamous and nonsquamous) with Stage IIIB/IIIC or Stage IV disease. * Participants must have a programmed death ligand-1 (PD-L1) expression ≥ 50%. * Participants must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * Participants must have no prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC. * Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. Exclusion Criteria * Participants must not have any documented actionable genomic alteration (AGA) for which first-line (1L) approved therapies are indicated. * Participants must not have any symptomatic untreated central nervous system (CNS) metastases, leptomeningeal metastases (carcinomatous meningitis) or spinal cord compression. * Participants must not have any significant cardiovascular impairment as evidenced by uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias, or major thrombotic or embolic events or major hemorrhagic events (within 6 months prior to randomization), or significant risk of pulmonary hemorrhage. * Participants must not an active autoimmune disease. * Other protocol-defined Inclusion/Exclusion criteria apply.
Contact & Investigator
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
✉ Clinical.Trials@bms.com📞 855-907-3286
Bristol-Myers Squibb
STUDY DIRECTOR
Bristol-Myers Squibb
Frequently Asked Questions
Who can join the NCT07361510 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-Small Cell Lung Cancer (NSCLC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07361510 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 750 participants.
Is NCT07361510 currently recruiting?
Yes, NCT07361510 is actively recruiting participants. Contact the research team at Clinical.Trials@bms.com for enrollment information.
Where is the NCT07361510 trial being conducted?
This trial is being conducted at Daphne, United States, Bullhead City, United States, Glendale, United States, Anaheim, United States and 11 additional locations.
Who is sponsoring the NCT07361510 clinical trial?
NCT07361510 is sponsored by Bristol-Myers Squibb. The principal investigator is Bristol-Myers Squibb at Bristol-Myers Squibb. The trial plans to enroll 750 participants.
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