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Clinical Trials in Italy / NCT07325136
Recruiting Phase 1/2

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 Italy tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 1/2
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
No
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)

FacilityCityRegionStatus
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

More Bristol-Myers Squibb trials in Italy

Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy Recruiting
A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5) Recruiting
A Study to Evaluate BMS-986470 in Healthy Volunteers and Participants With Sickle Cell Disease Recruiting
Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy for EGFRmt Non-small Cell Lung Cancer (IZABRIGHT-Lung02) Starting soon
A Study of BMS-986528 in Participants With Refractory Rheumatoid Arthritis Recruiting

Other trials for the same condition

A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC) Active, not 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 Italy