A Study of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT04702880
Phase
PHASE2
Status
Completed

Conditions

  • Extensive-stage Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BMS-986012 — BIOLOGICAL
    Specified dose on specified days
  • Carboplatin — DRUG
    Specified dose on specified days
  • Etoposide — DRUG
    Specified dose on specified days
  • Nivolumab — BIOLOGICAL
    Specified dose on specified days

Study Details

The purpose of this study is to demonstrate that treatment with BMS-986012 in combination with carboplatin, etoposide, and nivolumab will have acceptable safety and tolerability and will improve progression-free survival compared with carboplatin, etoposide, and nivolumab alone in newly diagnosed participants with extensive-stage small cell lung cancer (ES-SCLC).

Key Dates

Start date
Mar 17, 2021
Status verified
May 2026
Primary completion
May 22, 2025
Completion
Nov 28, 2025

Study Design

Enrollment
135 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012
  • Experimental: Arm B: Carboplatin + Etoposide + Nivolumab

Primary Outcome Measure

Number of Participants With Adverse Events [ Time Frame: From first dose to 100 days post last dose, or primary cutoff date, whichever occurs first (Up to approximately 43 months) ]

Locations (8)

FacilityCityStateZIPSite coordinators
Local Institution - 0075BirminghamAlabama35249-
Local Institution - 0022HackensackNew Jersey07601-
Local Institution - 0002DurhamNorth Carolina27710-
Local InstitutionCincinnatiOhio45267-
Local Institution - 0060CincinnatiOhio45267-
Local Institution - 0067ClevelandOhio44106-1716-
Local Institution - 0081NashvilleTennessee37203-
Local InstitutionDallasTexas75390-

Find similar trials in Birmingham, AL

By research site
Local Institution - 0075· Birmingham, ALLocal Institution - 0022· Hackensack, NJLocal Institution - 0002· Durham, NCLocal Institution· Cincinnati, OHLocal Institution - 0060· Cincinnati, OHLocal Institution - 0067· Cleveland, OH

Related Studies