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

First listed
Oct 23, 2023
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-

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