Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02481830
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
  • Topotecan — DRUG
  • Amrubicin — DRUG

Study Details

The purpose of this study is to compare the overall survival of nivolumab versus chemotherapy in subjects with relapsed SCLC.

Key Dates

Start date
Sep 14, 2015
Status verified
Jul 2023
Primary completion
Aug 17, 2018
Completion
Aug 30, 2022

Study Design

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

Arms

  • Experimental: Arm A Nivolumab
    Nivolumab intravenous infusion as specified
  • Active Comparator: Arm B Chemotherapy Topotecan
    Topotecan as specified
  • Active Comparator: Arm B Chemotherapy Amrubicin
    Amrubicin intravenous infusion as specified (upon investigator's choice, where locally approved for 2nd line SCLC treatment)

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: OS was followed continuously while participants were on the study drug and every 3 months, minimum follow up for overall survival was 15.8 months ]

Locations (14)

FacilityCityStateZIPSite coordinators
Local Institution - 0065Little RockArkansas72205-
Local Institution - 0024New HavenConnecticut06520-
Local Institution - 0018AtlantaGeorgia30322-
Local Institution - 0056St LouisMissouri63110-
Local Institution - 0088LincolnNebraska68506-
Local Institution - 0173Johnson CityNew York13790-
Local Institution - 0001DurhamNorth Carolina27710-
Local Institution - 0090ClevelandOhio44106-
Local Institution - 0002BethlehemPennsylvania18015-
Local Institution - 0057LancasterPennsylvania17604-
Local Institution - 0053PhiladelphiaPennsylvania19111-2412-
Local Institution - 0009NashvilleTennessee37232-
Local Institution - 0089NashvilleTennessee37203-
Local Institution - 0070KennewickWashington99336-

Find similar trials in Little Rock, AR

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Local Institution - 0065· Little Rock, ARLocal Institution - 0024· New Haven, CTLocal Institution - 0018· Atlanta, GALocal Institution - 0056· St Louis, MOLocal Institution - 0088· Lincoln, NELocal Institution - 0173· Johnson City, NY

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