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NCT Number: 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

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

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Key information

Conditions

Relapsed/Refractory Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Local Institution - 0028, Shanghai Shi, Shanghai Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986525

Drug

Specified dose on specified days

Pumitamig

Drug

Specified dose on specified days

Other names: BNT-327, BMS-986545

Primary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to approximately 2 years

  2. Number of participants with serious adverse events (SAEs)

    Time frame: Up to approximately 2 years

  3. Number of participants with AEs meeting dose-limiting toxicity (DLT) criteria

    Time frame: Up to 21 days

  4. Number of participants with AEs leading to discontinuation

    Time frame: Up to approximately 2 years

  5. Number of participants with AEs leading to death

    Time frame: Up to approximately 2 years

Secondary outcomes

  1. 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

  2. Maximum observed concentration within a dosing interval (Cmax)

    Time frame: Up to approximately 2 years

  3. Time of maximum observed plasma concentration within a dosing interval (Tmax)

    Time frame: Up to approximately 2 years

  4. Area under the concentration-time curve within a dosing interval (AUC(TAU))

    Time frame: Up to approximately 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1/2 Study of BMS-986525 as Monotherapy and in Combination Therapy in Participants With Relapsed/Refractory Small Cell Lung Cancer

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jan 8, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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