A Study About Safety and Efficacy of Pirfenidone to Treat Grade 2 or Grade3 Radiation-induced Lung Injury.

Phase 2 Completed 126 enrolled Beijing Continent Pharmaceutical Co, Ltd.

RandomizedParallel-groupOpen-labelTreatment

Summary

Using Pirfenidone to treat Grade 2 or Grade3 radiation-induced lung injury, and observe the efficacy and safety of the drug.

Timeline

Start: 2019-05-24
Primary completion: 2023-12-04
Completion: 2023-12-04

Outcome

Met primary endpoint

paper At week 24, the pirfenidone group showed an 8·0% improvement from baseline in DLCO%, whereas the control group showed a 2·4% reduction PMID 41207313 ↗

paper least squares mean difference 10·4%, 95% CI 4·3-16·5; p=0·0010). PMID 41207313 ↗

Publications

Hou Z, Dong B, Yao Q, Chen H, Shao Q, Li M, Wang J, Chen K, Zhu Z, Peng F, Wei S, Hu X, Li J, Liu M, Xu B, Zheng S, Bi N, Zheng S, Xu Q, Chen B, Wu C, Li R, Chen W, Liu X, Tian Y, Li X, Guo S, Zhao L, Zhu Y, Cai L, Li Q, Li L, Zhang H, Hu C, Wang L, Li Q, Chen B, Chen M. Pirfenidone for grade 2 and grade 3 radiation-induced lung injury: a multicentre, open-label, randomised, phase 2 trial. Lancet Oncol. 2025 Dec;26(12):1552-1562. doi: 10.1016/S1470-2045(25)00515-7. Epub 2025 Nov 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pirfenidone	Small molecule	400 mg	Oral