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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

March 10, 2021

Primary Completion Date

July 31, 2026

Study Completion Date

July 31, 2026

Conditions
Stage IIIA Non-small Cell Lung CancerStage IIIB Non-small Cell Lung Cancer
Interventions
DRUG

Durvalumab

"Preoperative Treatment:~* Non-squamous NSCLC: durvalumab 1125 mg, followed by pemetrexed 500 mg/m2 IV with cisplatin 75 mg/m2 IV, every 3 weeks, for 4 cycles~* Squamous NSCLC: durvalumab 1125 mg, followed by docetaxel 75 mg/m2 IV with cisplatin 75 mg/m2 IV, every 3 weeks, for 4 cycles~Adjuvant Therapy:~• 1-6 weeks after completion of radiotherapy, durvalumab 1500 mg IV every 4 weeks will be administered for 13 cycles."

PROCEDURE

Surgery

Patients will be re-evaluated following preoperative treatment to assess if patient is still medically fit to withstand surgery. Eligible patients will then undergo lobectomy, bilobectomy, sleeve lobectomy or other extended resection, or a pneumonectomy will be performed at the discretion of the attending thoracic surgeon.

RADIATION

Radiotherapy

4-10 weeks after surgery, patients will receive 54 Gy of radiotherapy with single daily fractions.

Trial Locations (9)

13210

SUNY Upstate Medical University, Syracuse

22908

University of Virginia Health System, Charlottesville

38120

Baptist Cancer Center, Memphis

60611

NorthWestern University, Chicago

60637

University of Chicago Medical Center, Chicago

77030

University of Texas MD Anderson Cancer Center, Houston

02114

Massachusetts General Hospital, Boston

02115

Brigham and Women's Hospital, Boston

01854

Lowell General Hospital, Lowell

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

Alliance Foundation Trials, LLC.

OTHER