A Study of BMS-986315 and Nivolumab in Combination With Chemotherapy in Participants With First-line Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

Part of paid clinical trials in Glendale, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT06094296
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • BMS-986315 — DRUG
    Specified dose on specified days
  • Nivolumab — DRUG
    Specified dose on specified days
  • Pemetrexed — DRUG
    Specified dose on specified days
  • Cisplatin — DRUG
    Specified dose on specified days
  • Carboplatin — DRUG
    Specified dose on specified days
  • Paclitaxel — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to evaluate the efficacy and safety of BMS-986315 plus nivolumab in combination with platinum-based doublet chemotherapy (PDCT) versus nivolumab in combination with PDCT in the first-line treatment of Stage IV or recurrent non-small cell lung cancer (NSCLC).

Key Dates

Start date
Nov 27, 2023
Status verified
Mar 2025
Primary completion
Aug 8, 2024
Completion
Aug 8, 2024

Study Design

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

Arms

  • Experimental: Part 1: BMS-986315 Dose Level (DL) 1 + Nivolumab + Histology-based PDCT
  • Experimental: Part 1: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT
  • Active Comparator: Part 2: Nivolumab + Histology-based PDCT
  • Experimental: Part 2: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT
  • Experimental: Part 2: BMS-986315 DL 1 + Nivolumab + Histology-based PDCT

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) for Part 1 [ Time Frame: From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months) ]

Locations (5)

FacilityCityStateZIPSite coordinators
Local Institution - 0038GlendaleCalifornia37219-
Local Institution - 0044ClermontFlorida34711-
Local Institution - 0040Orange CityFlorida32763-
Local Institution - 0058BoiseIdaho83706-
Local Institution - 0049HoustonTexas77090-

Related coverage on Hipa.ai

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By research site
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