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

StatusActive, Not Recruiting
PhasePhase 2
Started

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Record History

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  1. Results posted: Sep 23, 2026 Show 6 more changesShow less
    • Primary completion date changed from estimate of Jul 2026 to Feb 24, 2025
    • Study completion pushed from Jul 2026 to Jul 2027
    • Eligibility criteria expanded, about 61 words
    • Secondary endpoints: details revised at 1 of 7 entries
    • Site details revised at 1 of 9 sites
    • Publications: details revised at 34 of 35 entries
  2. Primary completion date changed from estimate of Jul 2026 to Feb 24, 2025
    • Study completion date: Jul 2026 to Jul 2027
    • Secondary endpoints revised (7)
    • Primary endpoint revised
    v14
  3. Primary completion date: Dec 2025 to Jul 2026
    • Study completion date: Jun 2026 to Jul 2026
    v13
  4. Primary completion date: Jul 2024 to Dec 2025v12 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 55 to confirmed 38
    • Study sites: 15 to 9
    • Study completion date: Sep 2024 to Jun 2026
  5. Primary completion date: Jul 2023 to Jul 2024
    • Site details revised at 2 of 15 sites
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. Primary completion date: Jul 2022 to Jul 2023v10
  2. Site contacts updated at 1 of 15 sitesv9
  3. Study sites: 13 to 15v8
  4. Primary completion date: Jul 2021 to Jul 2022v7
  5. Study sites: 12 to 13v6
  6. Re-verified, no change to tracked fieldsv5
  7. Study sites: 9 to 12v4
  8. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 8 to 9
    • Start date changed from estimate of Mar 2021 to Mar 10, 2021
    v3
  9. Start date: Sep 2019 to Mar 2021v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04062708
Lead Sponsor Alliance Foundation Trials, LLC.
Collaborators: AstraZeneca
Conditions
(from sponsor)		 Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 38 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov