CHIO3 Trial: CHemotherapy Combined With Immune Checkpoint Inhibitor for Operable Stage IIIA/B Non-Small Cell Lung Cancer (NCT04062708)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (39 items) and avoid the listed exclusions (20 items).
Location: NorthWestern University — Chicago, Illinois
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Any prior treatment for NSCLC.
- Prior thoracic radiation.
- Patients with ≥Grade 2 peripheral neuropathy.
- Any active or history of autoimmune disease (including any history of inflammatory bowel disease) or history of a syndrome that required systemic steroids or immunosuppressive medications, except for patients with vitiligo or resolved childhood asthma/atopy.
- Patients requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \<10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
- Patients with previous malignancies (except nonmelanoma skin cancers, in situ bladder, gastric, breast, colon or cervical cancers/dysplasia) are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study period.
- History of solid organ transplant.
- N3 nodal disease.
- Mixed small cell/NSCLC will be excluded.
- Pregnant or breastfeeding.
- History of allogenic organ transplantation.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (9 Sites)
- NorthWestern University — Chicago, Illinois
- University of Chicago Medical Center — Chicago, Illinois
- Massachusetts General Hospital — Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts
- Lowell General Hospital — Lowell, Massachusetts
- SUNY Upstate Medical University — Syracuse, New York
- Baptist Cancer Center — Memphis, Tennessee
- University of Texas MD Anderson Cancer Center — Houston, Texas
- University of Virginia Health System — Charlottesville, Virginia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.