A Study to Assess the Safety and Tolerability of BMS-986525 Alone and in Combination Therapy in Participants With Relapsed/Refractory Small Cell Lung Cancer

NCT07325136 · tracked via the Priya Life Science USA tracker

Sponsor

Bristol-Myers Squibb

Phase

Phase 1/Phase 2

Started

2026-02-03

Last updated

2026-09-14

Condition(s) studied

Relapsed/Refractory Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

BMS-986525Pumitamig

BMS-986525: Specified dose on specified days

Pumitamig: Specified dose on specified days

Study summary

The purpose of this study is to assess the safety and tolerability of BMS-986525 alone and in combination with Pumitamig in participants with Relapsed/Refractory Small Cell Lung Cancer

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria * Participants must have histologically or cytologically documented relapsed/refractory small cell lung cancer (R/R-SCLC). * Participants must have received at least 1 platinum-based chemotherapy regimen as per locally approved drug labels and institutional guidelines. * In countries where standard of care first line systemic treatment includes platinum containing chemotherapy in combination with anti-PD-(L)1 therapy, it is required that participants have progressed on, are ineligible for or not have access to an anti-PD- (L)1 therapy. Exclusion Criteria * Participants must not have any untreated CNS metastases. * Participants must not have an active, known or suspected autoimmune disease. * Participants must not have had a prior organ or tissue allograft. * Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcome measure(s)

Number of participants with adverse events (AEs) — Up to approximately 2 years
Number of participants with serious adverse events (SAEs) — Up to approximately 2 years
Number of participants with AEs meeting dose-limiting toxicity (DLT) criteria — Up to 21 days
Number of participants with AEs leading to discontinuation — Up to approximately 2 years
Number of participants with AEs leading to death — Up to approximately 2 years

Trial sites (13)

Facility	City	Region	Status
Karmanos Cancer Institute	Detroit	Michigan	Recruiting
Roswell Park Cancer Institute	Buffalo	New York	Recruiting
Duke Cancer Institute	Durham	North Carolina	Recruiting
University Hospitals Cleveland Medical Center	Cleveland	Ohio	Recruiting
SCRI Oncology Partners	Nashville	Tennessee	Recruiting
Local Institution - 0029	Beijing	Beijing Municipality	Not Yet Recruiting
Shanghai East Hospital	Shanghai	Shanghai Municipality	Recruiting
Istituto Clinico Humanitas	Rozzano	Milano	Recruiting
Local Institution - 0020	Hirakata	Osaka	Not Yet Recruiting
Local Institution - 0018	Chuo-ku	Tokyo	Not Yet Recruiting
Oncohelp Medical Center	Timișoara	Timiș County	Recruiting
Centrul de Oncologie Sf. Nectarie SRL	Craiova	Romania	Recruiting
Hospital Universitario 12 de Octubre	Madrid	Spain	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07325136 on ClinicalTrials.gov ↗ ← All trials in the USA