A Dose Frequency Optimization,Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received Up to 12 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks

Official Title

A Dose Frequency Optimization, Phase IIIB/IV Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received up to 12 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks

Summary:

The primary objective of this study is to show that PFS (progress-free survival) rate at 6 months and at 1 year after randomization, of Nivolumab 480 mg every 4 weeks is non-inferior to nivolumab 240 mg every 2 weeks in subjects with advanced/metastatic (Stage IIIb/IV) NSCLC (non-Sq and Sq).

Trial Description

Primary Outcome:

  • Progression Free Survival (PFS) rate at 6 months after randomization
  • Progression Free Survival (PFS) rate at 12 months after randomization
Secondary Outcome:
  • Progression Free Survival (PFS) rate after randomization by tumour histology and by response criteria
  • Progression Free Survival (PFS) rate
  • Overall Survival Rate (OSR)
  • Safety and Tolerability assessed by the incidence and severity of adverse events (AEs)

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society