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)

Inclusion Criteria:
•Age ≥18 years
•Histologically or cytologically documented NSCLC with resectable (Stage IIA to select [ie, N2] Stage IIIB) disease
•World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment
•At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline
•No prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines
•Adequate organ and marrow function
•Confirmation of a patients tumour PD-L1 status
•Documented EGFR and ALK status
Exclusion Criteria:
•Active or prior documented autoimmune or inflammatory disorders
•Patients who have pre-operative radiotherapy treatment as part of their care plan
•Patients who have brain metastases or spinal cord compression
Phase III
Ying Zhuo, M.D.
Paul Alderson
  • Kadlec Clinic Hematology and Oncology
  • Kadlec Research