Safety and Efficacy Study of Pirfenidone to Treat Grade 2 or Above Radiation-induced Lung Injury

Phase 2

• Conditions: Radiation Pneumonitis
• Interventions: Drug: Pirfenidone

• Registration Number: NCT02296281
• Lead Sponsor: Beijing Continent Pharmaceutical Co, Ltd.

Brief Summary

The purpose of this study is to assess the safety and efficacy of pirfenidone capsules to treat grade 2 or above radiation-induced lung injury patients.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-11
• Study First Submitted: 2014-11-18
• Study First Submitted QC: 2014-11-19
• Last Update Submitted: 2014-11-19
• Study First Posted: 2014-11-20
• Last Update Posted: 2014-11-20
• Study Start: 2015-01
• Primary Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. 18-70 years old (include 18 and 70 years), male or female
2. The pathological diagnosis of lung cancer, with non-small cell lung cancer (NSCLC) staging IIIA or IIIB, and small cell lung cancer (SCLC) in council deadline
3. General condition assessment, ECOG score of 0-1
4. Enough heart, liver and kidney function, such as AST, ALT, LDH≤2 times ULN such as plasma total bilirubin, creatinine ≤1.5 times ULN; hematopoietic function enough, such as neutrophils ≥4.0 x109 / L, platelets ≥100 x109 / L
5. The expected survival at 6 months or more
6. Subject is able to eat solid food
7. The initial radical thoracic radiotherapy treatment
8. The clinical diagnosis of radiation-induced lung injury in Grade 2 or above
9. The duration of radiation-induced lung injury in less than 1 month
10. Signed informed consent

Exclusion Criteria

1. Radiation-induced lung injury has entered the chronic phase
2. A history of chronic bronchitis, emphysema, or a history of cor pulmonale
3. Lung resection surgery
4. Cancer progression
5. Pulmonary infection
6. Associated with other serious diseases: such as occurred within 6 months of myocardial infarction, uncontrolled diabetes etc.
7. With active peptic ulcer
8. Pregnant women and patients with mental disease
9. Those who participate in clinical trials of other drugs within 3 months
10. Investigator judge does not apply to participate in the trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment group	Pirfenidone	-

Primary Outcome Measures

Name	Time	Method
Changes in radiation-induced lung injury classification	36 Weeks