Study of Pirfenidone Capsules for Treating Radiation-induced Lung Injury With or Without Immune-related Pneumonia in Adults

What this Trial Is About

Radiation-induced lung injury RILI is a common complication after thoracic radiotherapy, occurring in about 31.4% of patients. This condition, sometimes combined with immune-checkpoint inhibitor-related pneumonitis CIP, can disrupt cancer treatment and negatively affect patient outcomes. Both RILI and CIP share similar symptoms like fever, dry cough, and chest pain, and diagnosis involves symptom assessment and imaging such as computed tomography CT. This trial aims to find the best dose and evaluate the safety and effectiveness of pirfenidone capsules for treating RILI with or without CIP, addressing a critical need for better therapies. The study has two phases Phase II focuses on finding the optimal dose of pirfenidone, testing low-dose 400 mg three times daily, high-dose 600 mg three times daily, and placebo groups over 168 days of treatment and observation, followed by safety and survival follow-up. Phase III will confirm the chosen doses effects compared to placebo with a similar schedule and includes a long-term extension phase with survival assessments every three months. Participants will receive oral pirfenidone capsules or placebo with meals during the treatment period. Participants will undergo regular assessments including lung function tests like diffusing capacity of the lung for carbon monoxide DLCO, forced vital capacity FVC, and forced expiratory volume in one second FEV1. Other evaluations include symptom scores, CT imaging, blood tests, and monitoring for adverse events. The primary outcome is the change in lung diffusion capacity at 24 weeks. Safety follow-up occurs for about a month after treatment, and long-term monitoring continues in the extension phase. The total study participation spans from screening through treatment, safety follow-up, and extended survival tracking.

Pirfenidone Capsules in the Treatment of Radiation-induced Lung Injury With or Without Immune Pneumonia