MedTrace Logo

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

NCT04062708 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-07-08

No results posted yet for this 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

  • Stage IIIA Non-small Cell Lung Cancer
  • Stage 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.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Alliance Foundation Trials, LLC.

    lead OTHER

Principal Investigators

  • Evanthia Galanis, MD · Alliance Foundation Trials, LLC.

  • Linda Martin, MD, MPH · University of Virginia

  • Jyoti Patel, MD · University of Chicago

  • James Urbanic, MD · University of California, San Diego

  • David Kozono, MD · Alliance Foundation Trials, LLC.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-10
Primary Completion
2026-07-31
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04062708 on ClinicalTrials.gov