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

NCT03902509 | Completed Phase 2

• 1 other identifier: RP-F647-201901
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Radiation-induced Lung Injury

Keywords

pirfenidone

Outcome Measures

Primary Outcomes (1)

• DLco% change

  Compare DLco% from basement to the end of treatment

  Week 4, 8,16, and 24

Secondary Outcomes (4)

• The grade change of radiation-induced lung injury

  Week 4, 8,16, and 24

• The score change of CT

  Week 4, 8,16, and 24

• Increase of effective lung volume

  Week 4, 8,16, and 24

• The grade change of Cough, Dyspnea and Fever

  Week 4, 8,16, and 24

Study Arms (2)

Pirfenidone

EXPERIMENTAL

pirfenidone + basic treatment

Drug: Pirfenidone; Drug: basic treatment

Controll

OTHER

with basic treatment and without pirfenidone treatment

Drug: basic treatment

Interventions

Pirfenidone DRUG

pirfenidone capsule made in China

Pirfenidone

basic treatment DRUG

glucocorticoid and expectant treatment etc.

Controll; Pirfenidone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old (including 18 and 75 years);
• clinically diagnosed grade 2 or 3 radiation-induced lung injury;
• the course of radiation-induced lung injury is less than 2 months;
• ECOG 0-2;
• the expected survival time is more than 6 months;
• the functional level of major organs meets the following standards: ANC≥3.0×109/L，PLT≥100×109/L，Hb≥90g/L, TBIL、BUN and Cr≤1.5×ULN， ALT、AST≤2.0×ULN
• capable of eating solid food upon enrollment;
• subjects will voluntarily participate in this study and sign the informed consent.

You may not qualify if:

• have a history of chronic bronchial acute attack or severe pulmonary heart disease;
• pneumonectomy;
• tumor progression;
• severe pulmonary infection;
• creatinine clearance rate \< 30ml/min, severe renal disease or need dialysis;
• concomitant with other serious diseases: for example, myocardial infarction within 6 months, uncontrolled diabetes, etc., were considered not suitable for the participants in the study;
• patients with active peptic ulcer;
• pregnant women and patients with mental illness;
• participating in clinical trials of other drugs within 3 months;
• the investigator determined that subject was not suitable.

Sponsors & Collaborators

• Beijing Continent Pharmaceutical Co, Ltd.: lead

Study Sites (2)

Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100021, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Related Publications (1)

• 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.

  PMID: 41207313 DERIVED

MeSH Terms

Interventions

pirfenidone

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 4, 2019
• Study Start: May 24, 2019
• Primary Completion: December 4, 2023
• Study Completion: December 4, 2023
• Last Updated: May 4, 2025

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)