A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer

Official Title

A Phase III, Double-blind, Placebo-controlled, Multi-centre International Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN)

Summary:

This is a Phase III, randomized, double-blind, placebo-controlled, multi-centre international study assessing the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of pathological complete response.

Trial Description

Primary Outcome:

  • Pathological Complete Response (pCR) in modified intent-to-treat (mITT)
  • Event-Free Survival (EFS)
Secondary Outcome:
  • Disease-free survival (DFS) in modified resected population
  • Major Pathological Response (mPR)
  • Overall Survival (OS)
  • Event-free survival (EFS) in PD-L1-TC ≥1% positive patients
  • pCR in PD-L1-TC ≥1% positive patients
  • Disease-Free Survival (DFS) in PD-L1-TC ≥1% positive patients
  • Major Pathological Response (mPR) in PD-L1-TC ≥1% positive patients
  • Overall Survival (OS) in PD-L1-TC ≥1% positive patients
  • To assess disease-related symptoms and HRQoL (EORTC QLQ-C30) in patients treated with durva + chemo prior to surgery followed by durva post-surgery compared with placebo + chemo prior to surgery followed by placebo post-surgery
  • To assess disease-related symptoms and HRQoL (EORTC QLQ-LC13) in patients treated with durva + chemo prior to surgery followed by durva post-surgery compared with placebo + chemo prior to surgery followed by placebo post-surgery
  • To assess the PK of durvalumab in blood (through concentration)
  • Presence of ADA for durvalumab

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