ADOPT-lung is an international, multicentre, open-label randomised phase III trial. Protocol treatment consists of 3-4 cycles of neoadjuvant durvalumab in combination with platinum-based doublet chemotherapy, followed by surgery. Patients with R0 and R1 only resection will be randomised to receive either adjuvant durvalumab for 12 cycles (experimental arm) or observation (control arm). The primary objective of the study is to determine whether additional adjuvant immunotherapy with durvalumab after neoadjuvant chemo-immunotherapy has an effect on disease-free survival (DFS) in patients who do not achieve complete pathological response (pCR) as per local assessment according to the IASLC recommendations.
Histologically confirmed NSCLC.
Stage IIB-IIIB (T1-4 N0-2) according to 8th edition of the TNM staging system of lung cancer.
Known PD-L1 status, as tested locally using a validated assay. To ensure comparability of results, it is strongly encouraged that PD-L1 testing is done with the Ventana PD-L1 (SP263) assay.
Absence of EGFR mutation or ALK translocation, as tested locally.
T4 with invasion of heart, great vessels, carina, trachea, oesophagus, or spine.
Any previous or concurrent treatments for NSCLC.
Any previous immunotherapy.
Major surgical procedure (as per investigators assessment) within 28 days before enrolment.
ETOP IBCSG Partners Foundation
Lead sponsor
AstraZeneca
Collaborator