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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 · Bristol-Myers Squibb
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Official title
A Phase 1/2 Study of BMS-986525 as Monotherapy and in Combination Therapy in Participants With Relapsed/Refractory Small Cell Lung Cancer
About this study
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 criteria
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.
Study design
Enrollment target: 240 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-02-03
Estimated completion: 2029-04-24
Last updated: 2026-07-17
Interventions
Drug: BMS-986525Drug: Pumitamig
Primary outcomes
  • 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)
Sponsor
Bristol-Myers Squibb · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (12)
Karmanos Cancer InstituteRecruiting
Detroit, Michigan, United States
Local Institution - 0026Not Yet Recruiting
Buffalo, New York, United States
Duke Cancer InstituteRecruiting
Durham, North Carolina, United States
University Hospitals Cleveland Medical CenterRecruiting
Cleveland, Ohio, United States
SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
Local Institution - 0028Not Yet Recruiting
Shanghai Shi, Shanghai Municipality, China
Istituto Clinico HumanitasRecruiting
Rozzano, Milano, Italy
Local Institution - 0020Not Yet Recruiting
Hirakata, Osaka, Japan
Local Institution - 0018Not Yet Recruiting
Chuo-ku, Tokyo, Japan
Oncohelp Medical CenterRecruiting
Timișoara, Timiș County, Romania
Local Institution - 0003Not Yet Recruiting
Craiova, Romania
Local Institution - 0009Not Yet Recruiting
Madrid, Spain
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 · TrialPath