A Study of Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Second-Line Nivolumab Monotherapy in Asia

Sponsor
Bristol-Myers Squibb
Study ID
NCT03195491
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — BIOLOGICAL
    Intravenous infusion administered over 30 minutes at 240 mg

Study Details

The purpose of this study is to investigate the safety of patients in Asia with Non-Small Cell Lung Cancer (NSCLC)who are treated with Nivolumab monotherapy as a second line or third line treatment.

Key Dates

Start date
Dec 25, 2017
Status verified
Jan 2024
Primary completion
Jun 8, 2021
Completion
Jun 8, 2021

Study Design

Enrollment
400 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Monotherapy
    Nivolumab administered every two weeks

Primary Outcome Measure

Number of Non-HBV Participants Experiencing High Grade Treatment-Related Select Adverse Events [ Time Frame: From first dose up to 100 days post dose, up to approximately 36 months ]

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