Clinical Trial

CHIO3 Trial: CHemotherapy Combined With Immune Checkpoint Inhibitor for Operable Stage IIIA/B Non-Small Cell Lung Cancer

Active, Not Recruiting Phase 2
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Record status
This record was last updated July 8, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
Summary
This is a single arm, phase II trial of combined neoadjuvant platinum doublet chemotherapy plus durvalumab followed by surgery, postoperative radiation and adjuvant durvalumab for 13 cycles for patients with potentially resectable stage IIIA and IIIB (T1-3, N2) NSCLC (per the 8th International Association for the Study of Lung Cancer classification). The primary objective of this study is to increase N2 nodal clearance (N2NC) to 50% or greater for combined platinum doublet chemotherapy with durvalumab induction therapy from historical rate of 30% for platinum doublet chemotherapy alone in patients with potentially resectable stage IIIA/B (N2) NSCLC.
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2019-08-19; most recent amendment 2025-07-02.
Status change: Recruiting → Active, Not Recruiting 2024-02-02
Status change: Not Yet Recruiting → Recruiting 2021-04-14
Trial Details
NCT Number NCT04062708
Lead Sponsor Alliance Foundation Trials, LLC.
Collaborators: AstraZeneca
Conditions Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer
Enrollment 38 participants
Start Date 2021-03-10
Primary Completion 2026-07 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2025-07-08