An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy

Official Title

A Randomized, Multicentre, Double-Blind, Phase 3 Study of Nivolumab, Nivolumab in Combination With Ipilimumab, or Placebo as Maintenance Therapy in Subjects With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based First Line Chemotherapy (CheckMate 451: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 451)

Summary:

In this study, all patients must have already completed first-line chemotherapy to treat extensive-stage disease small cell lung cancer. The purpose of this study is to show that Nivolumab, or Nivolumab plus Ipilimumab followed by Nivolumab by itself, will prolong overall survival and progression free survival when administered as consolidation treatment in patients that are stable or responding after chemotherapy. Patients receiving treatment will be compared with patients taking placebo.

Trial Description

Primary Outcome:

  • Overall Survival (OS)
  • Progression-free survival (PFS)
Secondary Outcome:
  • A PFS descriptive analysis will be performed to evaluate nivolumab monotherapy versus nivolumab with Ipilimumab treatment regimen
  • An OS descriptive analysis will be performed to evaluate nivolumab monotherapy versus nivolumab with Ipilimumab treatment regimen

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society