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 major pathological response.

Trial Description

Primary Outcome:

• Major Pathological Response (mPR)
• Event-free survival

• Pathological complete response (pCR)
• mPR in PD-L1-TC positive patients
• Event-free survival (EFS)
• Disease-free survival (DFS)
• Overall Survival (OS)
• 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
• EFS and DFS in PD-L1 TC positive patients

View this trial on ClinicalTrials.gov