An Immuno-Therapy Study of Experimental Medication BMS-986205 Given With Nivolumab With or Without Chemotherapy Compared to Chemotherapy in Participants With Previously Untreated Stage IV or Recurrent Non-Small Cell Lung Cancer

Part of paid clinical trials in San Diego, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03417037
Phase
PHASE3
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • BMS-986205 — DRUG
    Administered orally daily, 100 mg
  • Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • Chemotherapy — DRUG
    Platinum-based doublet chemotherapy

Study Details

This is a study of experimental medication BMS-986205 given with Nivolumab with or without chemotherapy compared to chemotherapy in participants with previously untreated stage IV or recurrent non-small cell lung cancer.

Key Dates

First listed
Jan 31, 2018
Start date
May 24, 2018
Status verified
Apr 2018
Primary completion
Apr 25, 2021
Completion
Aug 20, 2025

Study Design

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

Arms

  • Experimental: Arm A
    BMS-986205 and Nivolumab administered in combination
  • Experimental: Arm B
    BMS-986205 and Nivolumab administered in combination with chemotherapy
  • Active Comparator: Arm C
    Chemotherapy administered alone

Primary Outcome Measure

Objective response rate (ORR) measured by number of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group [ Time Frame: 24 months ]

Locations (19)

FacilityCityStateZIPSite coordinators
Local InstitutionSan DiegoCalifornia92123-
Local InstitutionFort MyersFlorida33916-
Local InstitutionJacksonvilleFlorida32256-
Local InstitutionSt. PetersburgFlorida33705-
Local InstitutionTallahasseeFlorida32308-
Local InstitutionWest Palm BeachFlorida33401-
Local InstitutionDecaturGeorgia30033-
Local InstitutionMariettaGeorgia30060-
Local InstitutionWichitaKansas67214-
Local InstitutionLouisvilleKentucky40202-
Local InstitutionBostonMassachusetts02114-
Local InstitutionBridgetonMissouri63044-
Local InstitutionLincolnNebraska68510-
Local InstitutionClevelandOhio44106-
Local InstitutionGettysburgPennsylvania17325-
Local InstitutionGreenvilleSouth Carolina29607-
Local InstitutionLebanonTennessee37087-
Local InstitutionFort WorthTexas76104-
Local InstitutionLubbockTexas79430-0002-

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