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OncoMatch/Clinical Trials/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)

Is NCT07361510 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including Pumitamig and Pembrolizumab for non-small cell lung cancer (nsclc).

Phase 3RecruitingBristol-Myers SquibbNCT07361510Data as of Jun 2026Location: International · 36 countries

Treatment: Pumitamig · PembrolizumabThe 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%.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Pembrolizumab

Other

Pumitamig

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: PD-L1 (CD274) expression ≥ 50% (≥ 50%)

Disease stage

Required: Stage IIIB, IIIC, IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Lab requirements

Cardiac function

no 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

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

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Local Institution - 0348 · Daphne, Alabama
  • Local Institution - 0391 · Glendale, Arizona
  • Local Institution - 0407 · Anaheim, California
  • Local Institution - 0352 · Beverly Hills, California
  • Orange Coast Memorial Medical Center · Fountain Valley, California

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT07361510 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require CD274?

Yes, CD274 expression ≥ 50% is a required biomarker for enrollment.

What disease stage is eligible?

Stage IIIB or IIIC or IV is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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