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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Durvalumab — DRUG
  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.
• Surgery — PROCEDURE
  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.
• Radiotherapy — RADIATION
  4-10 weeks after surgery, patients will receive 54 Gy of radiotherapy with single daily fractions.

Study Details

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.

Key Dates

Start date

Mar 10, 2021

Status verified

Jun 2025

Primary completion

Jul 31, 2026

Completion

Jul 31, 2026

Study Design

Enrollment

38 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment
  Combined neoadjuvant platinum doublet chemotherapy plus durvalumab followed by surgery, postoperative radiation and adjuvant durvalumab for 13 cycles.

Primary Outcome Measure

N2 nodal clearance (N2NC) [ Time Frame: 5 years ]

Locations (9)

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