Recruiting NCT07325136
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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BMS-986525, Pumitamig.
- Who it may be relevant to
- Registry conditions: Relapsed/Refractory Small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, China, Italy, Japan, Romania +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
Interventions
- Drug BMS-986525
Specified dose on specified days - Drug Pumitamig
Specified dose on specified days
Primary outcome measures
- Number of participants with adverse events (AEs) [Time frame: Up to approximately 2 years]
- Number of participants with serious adverse events (SAEs) [Time frame: Up to approximately 2 years]
- Number of participants with AEs meeting dose-limiting toxicity (DLT) criteria [Time frame: Up to 21 days]
- Number of participants with AEs leading to discontinuation [Time frame: Up to approximately 2 years]
- Number of participants with AEs leading to death [Time frame: Up to approximately 2 years]
Secondary outcome measures (4)
- Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumor Version 1.1 (RECIST v1.1) by investigator assessment [Time frame: Up to approximately 3 years]
- Maximum observed concentration within a dosing interval (Cmax) [Time frame: Up to approximately 2 years]
- Time of maximum observed plasma concentration within a dosing interval (Tmax) [Time frame: Up to approximately 2 years]
- Area under the concentration-time curve within a dosing interval (AUC(TAU)) [Time frame: Up to approximately 2 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 5 centers
- Karmanos Cancer Institute — Detroit
- Local Institution - 0026 — Buffalo
- Duke Cancer Institute — Durham
- University Hospitals Cleveland Medical Center — Cleveland
- SCRI Oncology Partners — Nashville
Japan · 2 centers
- Local Institution - 0020 — Hirakata
- Local Institution - 0018 — Chuo-ku
Romania · 2 centers
- Oncohelp Medical Center — Timișoara
- Local Institution - 0003 — Craiova
China · 1 center
- Local Institution - 0028 — Shanghai Shi
Italy · 1 center
- Istituto Clinico Humanitas — Rozzano
Spain · 1 center
- Local Institution - 0009 — Madrid
Identifiers
NCT: NCT07325136 · CA258-0001 · 2025-524090-16