Efficacy Study of Nivolumab Compared to Docetaxel in Subjects Previously Treated With Advanced or Metastatic Non Small Cell Lung Cancer

Sponsor
Bristol-Myers Squibb
Study ID
NCT02613507
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to determine whether Nivolumab improves life expectancy compared to Docetaxel in Subjects with Advanced or Metastatic Non-small Cell Lung Cancer who have failed prior platinum-based doublet chemotherapy.

Key Dates

Start date
Dec 11, 2015
Status verified
Nov 2024
Primary completion
Sep 15, 2017
Completion
Nov 24, 2023

Study Design

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

Arms

  • Experimental: Arm A: Nivolumab
    Nivolumab Intravenous infusion specified dose on specified days
  • Active Comparator: Arm B: Docetaxel
    Docetaxel Intravenous infusion specified dose on specified days

Primary Outcome Measure

Median Overall Survival [ Time Frame: From randomization to the date of death or date participant was last known to be alive (assessed from December 2015 to Oct 2017 approximately 22 months) ]

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