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


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 expression TC ≥ 25%, in patients with PD-L1 expression TC ≥ 1%
  • Compare Disease Free Survival in all randomized patients
Secondary Outcome:
  • Compare overall survival (OS) for patients with PD-L1
  • ≥ 25%, PD-L1 ≥ 1%, and in 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 ≥ 25%, PD-L1 ≥ 1% 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

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society