A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer (AEGEAN)
A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer (AEGEAN)
This is a Phase III, randomized, double-blind, placebo-controlled, multi-center 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.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN)
Actual Study Start Date: December 6, 2018
Estimated Primary Completion Date: April 30, 2024
Estimated Study Completion Date: April 30, 2024
Arm:
- Experimental: Arm 1: Durvalumab + platinum-based chemotherapy
- Placebo Comparator: Arm 2: Placebo + platinum-based chemotherapy
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 800 |
| Actual Study start date | 06 December 2018 |
| Estimated Study Completion Date | 30 April 2024 |