A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer.

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.

NCT Number	NCT06284317
Lead Sponsor	ETOP IBCSG Partners Foundation Collaborators: AstraZeneca
Conditions	Non Small Cell Lung Cancer
Enrollment	290 participants
Start Date	2025-01-15
Primary Completion	2029-10 (estimated)
Study Completion	2030-03 (estimated)
Updated on ClinicalTrials.gov	2026-05-14