Double Blind Placebo Controlled Study of Adjuvant MEDI4736 In Completely Resected NSCLC

Official Title

A Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 In Completely Resected Non-Small Cell Lung Cancer

Summary:

The purpose of this study is to find out whether it is better to receive a new drug, MEDI4736, or better to receive no further treatment after surgery (and possibly chemotherapy) for lung cancer.

Trial Description

Primary Outcome:

  • Compare Disease free survival (DFS) for patients with NSCLC that is PD-L1 positive
Secondary Outcome:
  • Compare Disease Free Survival in all randomized patients
  • Compare overall survival (OS) for patients with NSCLC that is PD-L1 positive
  • Compare overall survival for all randomized patients
  • Compare Lung cancer specific survival for patients with NSCLC that is PD-L1 positive and all randomized patients
  • Evaluate the nature, severity and frequency of adverse effects and tolerability of MEDI4736
  • Evaluate the Quality of life between the two treatment arms in PD-L1+ patients and in all randomized patients.
  • Determine survival benefits participants judge necessary to make adjuvant immunotherapy worthwhile
  • Determine the incremental cost effectiveness and cost utility ratios for MEDI4736
  • Evaluate the predictive/prognostic significance of PD-L1 expression
  • Evaluation of changes in plasma/serum cytokines and other blood and tissue based biomarkers after treatment with MEDI4736 and at disease event
  • Explore polymorphisms that may be associated with outcomes

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