A Phase 3 interventional study of Pumitamig and Pembrolizumab in Non-Small Cell Lung Cancer (NSCLC), sponsored by Bristol-Myers Squibb. Recruiting at 284 sites in 36 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Bristol-Myers Squibb · Phase 3, Interventional, and Treatment
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%.
Exclusion Criteria
Drug: Pumitamig
Drug: Pembrolizumab
Specified dose on specified days
Also known as: BMS-986545
Specified dose on specified days
Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to approximately 3 years
Overall survival (OS)
Time frame: Up to approximately 5 years
PFS by investigator according to RECIST v1.1
Time frame: Up to approximately 3 years
Objective Response (OR) by BICR according to RECIST v1.1
Time frame: Up to approximately 3 years
Duration of response (DOR) by BICR according to RECIST v1.1
Time frame: Up to approximately 3 years
Disease control rate (DCR) by BICR according to RECIST v1.1
Time frame: Up to approximately 3 years
Time to Response (TTR) by BICR according to RECIST v1.1
Time frame: Up to approximately 3 years
Time to definitive deterioration (TTDD) based on the Non-Small Cell Lung Cancer-Symptom Assessment Questionnaire (NSCLC-SAQ) defined as the time from randomization until a definitive clinically meaningful worsening in symptoms or in NSCLC-SAQ total score
Time frame: Up to approximately 3 years
Showing the first 100 of 284 sites across 36 countries.
Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Supporting information: Study protocol, Sap, Csr
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Carcinoma, Non-Small-Cell Lung→
Bristol-Myers Squibb