A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)

Part of paid clinical trials in Glendale, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02998528
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • Cisplatin — DRUG
    Specified dose on specified days
  • Vinorelbine — DRUG
    Specified dose on specified days
  • Gemcitabine — DRUG
    Specified dose on specified days
  • Docetaxel — DRUG
    Specified dose on specified days
  • Pemetrexed — DRUG
    Specified dose on specified days
  • Carboplatin — DRUG
    Specified dose on specified days
  • Paclitaxel — DRUG
    Specified dose on specified days
  • Ipilimumab — BIOLOGICAL
    This arm is closed and no longer enrolling patients.

Study Details

The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC. This study has multiple primary endpoints.

Key Dates

First listed
Dec 20, 2016
Start date
Mar 4, 2017
Status verified
Jan 2026
Primary completion
Sep 8, 2021
Completion
Dec 6, 2024

Study Design

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

Arms

  • Active Comparator: Platinum doublet chemotherapy
    Specified dose on specified days
  • Experimental: Nivolumab plus platinum doublet chemotherapy
    Specified dose on specified days
  • Experimental: Nivolumab plus Ipilimumab
    Specified dose on specified days

Primary Outcome Measure

Event-Free Survival (EFS) [ Time Frame: From randomization to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months) ]

Locations (57)

FacilityCityStateZIPSite coordinators
Local Institution - 0121GlendaleArizona85308-
Local Institution - 0081Los AngelesCalifornia90017-
Local Institution - 0025DenverColorado80218-
Local Institution - 0007PlainvilleConnecticut06062-
Local Institution - 0173HollywoodFlorida33021-
Local Institution - 0136MiamiFlorida33136-
Local Institution - 0054OrlandoFlorida32804-
Orlando Health, Inc.OrlandoFlorida32806-
Indian River Medical CenterVero BeachFlorida32960-
Northwest Georgia Oncology Center, P.C.MariettaGeorgia30060-
Local Institution - 0002ChicagoIllinois60637-
Local Institution - 0015ChicagoIllinois60611-
Illinois Cancer SpecialistsNilesIllinois60714-
Local Institution - 0171Fort WayneIndiana46804-
Local Institution - 0170LexingtonKentucky40536-
Local Institution - 0186LouisvilleKentucky40202-
University Medical Center New OrleansNew OrleansLouisiana70112-
Local Institution - 0001BaltimoreMaryland21287-
Local Institution - 0151BaltimoreMaryland21237-
Local Institution - 0008BostonMassachusetts02215-
Southcoast Center For CancerFairhavenMassachusetts02719-
Local Institution - 0006NewtonMassachusetts02459-
Local Institution - 0012DetroitMichigan48202-2608-
Local Institution - 0090HattiesburgMississippi39401-
St Vincent Frontier Cancer CenterBillingsMontana59102-
Local Institution - 0032Las VegasNevada89128-
Local Institution - 0009HackensackNew Jersey07601-
Valley Hospital Luckow PaviliWestwoodNew Jersey07675-
Local Institution - 0027AlbanyNew York12208-
Local Institution - 0011New YorkNew York10016-
Local Institution - 0140High PointNorth Carolina27262-
Christ HospitalCincinnatiOhio45219-
MetroHealth Medical CenterClevelandOhio44109-
Local Institution - 0149ZanesvilleOhio43701-
Kaiser PermanentePortlandOregon97227-
Local Institution - 0139PortlandOregon97239-
Local Institution - 0010PhiladelphiaPennsylvania19111-
Local Institution - 0018PittsburghPennsylvania15212-
Local Institution - 0013CharlestonSouth Carolina29414-
Local Institution - 0021CharlestonSouth Carolina29425-
Local Institution - 0146GreenvilleSouth Carolina29607-
Local Institution - 0005NashvilleTennessee37232-
Local Institution - 0092NashvilleTennessee37203-
Local Institution - 0035AustinTexas78745-
Texas OncologyBedfordTexas76022-
Local Institution - 0153Fort BlissTexas79918-
Local Institution - 0106HoustonTexas77090-
Southwest Cancer CenterLubbockTexas79415-
Texas Cancer Center - ShermanShermanTexas75090-0504-
Local Institution - 0143TylerTexas75701-
Local Institution - 0026WacoTexas76712-
Intermountain Medical CenterMurrayUtah84107-
Local Institution - 0003Salt Lake CityUtah84112-
Southwest Regional Cancer ClinicSt. GeorgeUtah84770-
Local Institution - 0135BurlingtonVermont05405-
Local Institution - 0125FairfaxVirginia22031-
Local Institution - 0198FredericksburgVirginia22408-

Find similar trials in Glendale, AZ

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Local Institution - 0121· Glendale, AZLocal Institution - 0081· Los Angeles, CALocal Institution - 0025· Denver, COLocal Institution - 0007· Plainville, CTLocal Institution - 0173· Hollywood, FLLocal Institution - 0136· Miami, FL

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