A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor (TKI) Therapy

Part of paid clinical trials in Long Beach, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02864251
Phase
PHASE3
Status
Completed

Conditions

  • Non-Small-Cell Lung Carcinoma

Eligibility Criteria

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

Interventions

  • Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • Ipilimumab — BIOLOGICAL
    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

Study Details

The main purpose of this study is to determine whether nivolumab + chemotherapy is effective as compared to chemotherapy in the treatment of patients with EGFR mutation, NSCLC who failed first line (1L) or second-line (2L) EGFR TKI therapy.

Key Dates

Start date
Mar 17, 2017
Status verified
Sep 2023
Primary completion
Jan 20, 2022
Completion
Oct 17, 2022

Study Design

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

Arms

  • Experimental: Nivolumab+Platinum doublet chemotherapy
  • Experimental: Nivolumab + Ipilimumab
    Enrollment is closed for this arm
  • Active Comparator: Platinum doublet chemotherapy

Primary Outcome Measure

Progression Free Survival (PFS) by Blinded Independent Centralized Review (BICR) [ Time Frame: From randomization to the date of first documented tumor progression or death (approximately 58 months) ]

Locations (18)

FacilityCityStateZIPSite coordinators
Pacific Shores Medical GroupLong BeachCalifornia90808-
Local Institution - 0029Los AngelesCalifornia90017-
Local Institution - 0033Los AngelesCalifornia90095-
Local Institution - 0061OrangeCalifornia92868-
Torrance Memorial Physican NetworkRedondo BeachCalifornia90277-
Local Institution - 0003New HavenConnecticut06520-
Local Institution - 0004ChicagoIllinois60637-
Johns Hopkins UniversityBaltimoreMaryland21205-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Local Institution - 0002BostonMassachusetts02114-
Local Institution - 0064New YorkNew York10016-
Duke University Medical CenterButnerNorth Carolina27509-1626-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Texas Health Physicians GroupArlingtonTexas76012-
Baylor Scott and White Research InstituteTempleTexas76508-
Local Institution - 0063TylerTexas75701-
Local Institution - 0001Salt Lake CityUtah84112-

Find similar trials in Long Beach, CA

By research site
Pacific Shores Medical Group· Long Beach, CALocal Institution - 0029· Los Angeles, CALocal Institution - 0033· Los Angeles, CALocal Institution - 0061· Orange, CATorrance Memorial Physican Network· Redondo Beach, CALocal Institution - 0003· New Haven, CT

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