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NCT04062708 · ClinicalTrials.gov registry record · Phase 2
CHIO3 Trial: CHemotherapy Combined With Immune Checkpoint Inhibitor for Operable Stage IIIA/B Non-Small Cell Lung Cancer
A Phase 2 study of Stage IIIB Non-small Cell Lung Cancer and Stage IIIA Non-Small Cell Lung Cancer, sponsored by Alliance Foundation Trials.
- Active
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 9
- Study locations
NCT04062708 is a Phase 2 study of Stage IIIB Non-small Cell Lung Cancer and Stage IIIA Non-Small Cell Lung Cancer that is active but no longer recruiting, run by Alliance Foundation Trials. The registered enrollment target is 38 participants, below the 46-participant average among 16 other Stage IIIB Non-small Cell Lung Cancer trials with a reported enrollment target (17% lower). The trial reports 9 study locations across 6 states.
The verdict
NCT04062708, a Phase 2 study of Stage IIIB Non-small Cell Lung Cancer and Stage IIIA Non-Small Cell Lung Cancer, is active but no longer recruiting, sponsored by Alliance Foundation Trials.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 9
- Study locations
Study 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.
Conditions Studied
Interventions
- RADIATION Radiotherapy
- PROCEDURE Surgery
- DRUG Durvalumab
Study Locations (9)
Massachusetts
- Massachusetts General Hospital - Boston
- Brigham and Women's Hospital - Boston
- Lowell General Hospital - Lowell
Illinois
- NorthWestern University - Chicago
- University of Chicago Medical Center - Chicago
New York
- SUNY Upstate Medical University - Syracuse
Tennessee
- Baptist Cancer Center - Memphis
Texas
- University of Texas MD Anderson Cancer Center - Houston
Virginia
- University of Virginia Health System - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2021-03-10 |
| Est. Completion | 2026-07 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04062708
The ClinicalTrials.gov registry entry for NCT04062708 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 46-participant average among 16 other Stage IIIB Non-small Cell Lung Cancer trials with a reported enrollment target (17% lower). The listed sponsor is Alliance Foundation Trials, which has 20 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Stage IIIB Non-small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Radiotherapy is the first listed.
NCT04062708 reports 9 study locations spanning 6 distinct geographic areas - top geographies include Massachusetts, Illinois, New York.
Frequently Asked Questions
What is clinical trial NCT04062708 about?
NCT04062708 is a clinical study titled "CHIO3 Trial: CHemotherapy Combined With Immune Checkpoint Inhibitor for Operable Stage IIIA/B Non-Small Cell Lung Cancer". 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 Assoc...
What is the current status of trial NCT04062708?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2021-03-10. Estimated completion is 2026-07.
What conditions does trial NCT04062708 study?
This clinical trial studies the following conditions: Stage IIIB Non-small Cell Lung Cancer, Stage IIIA Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT04062708?
The interventions under investigation include: Radiotherapy (RADIATION), Surgery (PROCEDURE), Durvalumab (DRUG).
Who is sponsoring clinical trial NCT04062708?
This trial is sponsored by Alliance Foundation Trials, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04062708 being conducted?
This trial has 9 study locations across Illinois, Massachusetts, New York, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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