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. - Trial NCT06284317
Access comprehensive clinical trial information for NCT06284317 through Pure Global AI's free database. This Phase 3 trial is sponsored by ETOP IBCSG Partners Foundation and is currently Not yet recruiting. The study focuses on Non Small Cell Lung Cancer. Target enrollment is 290 participants.
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Study Focus
Sponsor & Location
ETOP IBCSG Partners Foundation
Timeline & Enrollment
Phase 3
Oct 01, 2024
Jan 01, 2030
Primary Outcome
Disease-free survival (DFS)
Summary
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06284317
Non-Device Trial