RecruitingPhase 2NCT05801133

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


Sponsor

Hubei Cancer Hospital

Enrollment

41 participants

Start Date

Mar 31, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether pirfenidone — a drug typically used for lung scarring — can prevent or reduce radiation-related lung damage in lung cancer patients who have previously received immunotherapy (checkpoint inhibitor drugs). **You may be eligible if:** - You are 18 or older with lung cancer - You have received at least 2 cycles of immunotherapy (PD-1 or PD-L1 inhibitor drugs) within the past 6 months - You are in good general health (ECOG score 0 or 1) - You are expected to live at least 3 months - Your organ function tests are within acceptable ranges **You may NOT be eligible if:** - You have an active autoimmune disease requiring treatment (such as rheumatoid arthritis or type 1 diabetes) - You have active hepatitis B, hepatitis C, tuberculosis, or HIV - You have had a solid organ or bone marrow transplant - You are allergic to pirfenidone - You are participating in another drug trial - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPirfenidone

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


Locations(1)

Hubei Cancer Hospital

Wuhan, Hubei, China

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NCT05801133


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