Relapsed/Refractory Small Cell Lung Cancer
Conditions
Keywords
Extensive stage-small cell lung cancer (ES-SCLC)
Brief 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
Interventions
DRUGBMS-986525
Specified dose on specified days
DRUGPumitamig
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumor Version 1.1 (RECIST v1.1) by investigator assessment | Up to approximately 3 years |
| Maximum observed concentration within a dosing interval (Cmax) | Up to approximately 2 years |
| Time of maximum observed plasma concentration within a dosing interval (Tmax) | Up to approximately 2 years |
| Area under the concentration-time curve within a dosing interval (AUC(TAU)) | Up to approximately 2 years |
Countries
China, Italy, Japan, Romania, Spain, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed