A Safety Trial of Nivolumab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed During or After Receiving At Least One Prior Chemotherapy Regimen

Conditions

• Non Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nivolumab — DRUG

Study Details

The purpose of this study is to estimate the incidence and characterize the outcome of high grade, select adverse events in subjects with advanced or metastatic NSCLC treated with Nivolumab.

Key Dates

Start date

Apr 9, 2014

Status verified

Sep 2022

Primary completion

Oct 6, 2021

Completion

Oct 6, 2021

Study Design

Enrollment

1,428 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort A: Nivolumab
  Nivolumab 3 mg/kg solution intravenous infusion over 30 minutes every two weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent
• Experimental: Cohort B: Nivolumab
  Nivolumab 3 mg/kg solution intravenous infusion over 30 minutes every two weeks until 1 year (52 weeks). Discontinue treatment and at progression, retreatment allowed

Primary Outcome Measure

The Number of Participants With Treatment Related Select Adverse Events (Grade 3-4 and Grade 5) [ Time Frame: From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months) ]

Locations (127)

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