An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02477826
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
  • Ipilimumab — DRUG
  • Carboplatin — DRUG
  • Cisplatin — DRUG
  • Gemcitabine — DRUG
  • Pemetrexed — DRUG
  • Paclitaxel — DRUG

Study Details

The purpose of this study is to show that Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab plus Platinum-Doublet Chemotherapy improves progression free survival and/or overall survival compared with chemotherapy in patients with advanced lung cancer.

Key Dates

Start date
Aug 5, 2015
Status verified
Oct 2025
Primary completion
Oct 25, 2024
Completion
Oct 25, 2024

Study Design

Enrollment
2,747 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Nivolumab
    Nivolumab intravenously (IV) as specified
  • Experimental: Arm B: Nivolumab + Ipilimumab
    Nivolumab + Ipilimumab IV as specified
  • Experimental: Arm C: Nivolumab + Platinum doublet chemotherapy
    Nivolumab + Platinum doublet chemotherapy (IV) dose as specified
  • Experimental: Arm D: Platinum doublet chemotherapy
    Chemotherapy administered on specified days of IV chemotherapy

Primary Outcome Measure

Progression-Free Survival Per BICR [ Time Frame: From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks) ]

Locations (25)

FacilityCityStateZIPSite coordinators
Southern Cancer Center, Inc.MobileAlabama36608-
Local Institution - 0017San FranciscoCalifornia94115-
Local Institution - 0021New HavenConnecticut06520-
Local Institution - 0001AtlantaGeorgia30322-
Local Institution - 0013MariettaGeorgia30060-
Local Institution - 0004LexingtonKentucky40503-
Local Institution - 0115St LouisMissouri63110-
Local Institution - 0005BuffaloNew York14263-
Local Institution - 0019New YorkNew York10065-
Local Institution - 0014ClevelandOhio44106-
Local Institution - 0009ColumbusOhio43210-
Local Institution - 0007AllentownPennsylvania18103-
Local Institution - 0075LanghornePennsylvania19047-
Local Institution - 0012PhiladelphiaPennsylvania19111-2412-
Local Institution - 0299PhiladelphiaPennsylvania19107-
Local Institution - 0015SayrePennsylvania18840-
Local Institution - 0008CharlestonSouth Carolina29425-
Local Institution - 0010GreenvilleSouth Carolina29607-
Local Institution - 0080GreenvilleSouth Carolina29605-
Local Institution - 0020NashvilleTennessee37232-
Local Institution - 0003DallasTexas75390-
Local Institution - 0306DallasTexas75390-8852-
Local Institution - 0102HoustonTexas77030-
Local Institution - 0011Salt Lake CityUtah84108-
Local Institution - 0074KennewickWashington99336-

Related coverage on Hipa.ai

Find similar trials in Mobile, AL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Southern Cancer Center, Inc.· Mobile, ALLocal Institution - 0017· San Francisco, CALocal Institution - 0021· New Haven, CTLocal Institution - 0001· Atlanta, GALocal Institution - 0013· Marietta, GALocal Institution - 0004· Lexington, KY

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