NCT05801133

Pifenidone Prophylactic Therapy for Radiation Lung Injury in Patients Who Have Previously Received Immune Checkpoint Inhibitors

Pifenidone is Used to Reduce Radiation Lung Injury in Lung Cancer Patients Previously Treated With Immune Checkpoint Inhibitors: A Single-arm, Open-label, Phase II Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: Hubei Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with advanced lung cancer who have previously received immunocheckpoint inhibitor therapy, undergone chest radiation therapy again have developed radiation induced lung injury. Pirfenidone has anti-inflammatory and anti fibrosis effects. This study is intended to evaluate the effectiveness of pirfenidone combined with radiotherapy in the prevention of radiation pneumonitis.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Pirfenidone	200 mg TID in the first week, 300 mg TID in the second week, and maintenance treatment of 400 mg TID from the third week until 3 months

Timeline

• Start date: 2023-03-31
• Primary completion: 2025-03-31
• Completion: 2025-09-01
• First posted: 2023-04-06
• Last updated: 2024-03-15

Locations

1 site across 1 country: China