A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC

Part of paid clinical trials in Colorado Springs, Colorado.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03215706
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ipilimumab — BIOLOGICAL
    Specified dose on specified day
  • Nivolumab — BIOLOGICAL
    Specified dose on specified day
  • Carboplatin — DRUG
    Specified dose on specified day
  • Paclitaxel — DRUG
    Specified dose on specified day
  • Pemetrexed — DRUG
    Specified dose on specified day
  • Cisplatin — DRUG
    Specified dose on specified day

Study Details

The purpose of this study is to determine whether Nivolumab, Ipilimumab combined with chemotherapy is more effective than chemotherapy by itself when treating stage IV NSCLC as the first treatment given for the disease

Key Dates

Start date
Aug 24, 2017
Status verified
Dec 2025
Primary completion
Aug 16, 2019
Completion
Oct 18, 2024

Study Design

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

Arms

  • Experimental: Module A
    Chemotherapy/Biologics combined
  • Active Comparator: Module B
    Chemotherapy Combination

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From date of randomization to date of death (assessed up to October 2019, approximately 23 months) ]

Locations (16)

FacilityCityStateZIPSite coordinators
Memorial Health SystemsColorado SpringsColorado80909-
Local Institution - 0044PlainvilleConnecticut06062-
Local Institution - 0045JacksonvilleFlorida32207-
Local Institution - 0029MariettaGeorgia30060-
Local Institution - 0091WichitaKansas67214-
Local Institution - 0004LexingtonKentucky40503-
Local Institution - 0105DetroitMichigan48202-
Local Institution - 0058Johnson CityNew York13790-
Local Institution - 0098MineolaNew York11501-
Local Institution - 0095ColumbusOhio43210-
Local Institution - 0006LancasterPennsylvania17602-
Local Institution - 0047PittsburghPennsylvania15213-
Local Institution - 0093PittsburghPennsylvania15224-
Local Institution - 0094CharlestonSouth Carolina29414-
Southwest Regional Cancer ClinicSt. GeorgeUtah84770-
Local Institution - 0099MadisonWisconsin53705-

Find similar trials in Colorado Springs, CO

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Memorial Health Systems· Colorado Springs, COLocal Institution - 0044· Plainville, CTLocal Institution - 0045· Jacksonville, FLLocal Institution - 0029· Marietta, GALocal Institution - 0091· Wichita, KSLocal Institution - 0004· Lexington, KY

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