RecruitingInterventionalPhase 3Updated Nov 24, 2025
Safety and Efficacy Study of Pirfenidone to Treat Grade 2 or Above Radiation-induced Lung Injury | NCT02296281 | Trialant
Unknown statusInterventionalPhase 2Updated Nov 20, 2014
Safety and Efficacy Study of Pirfenidone to Treat Grade 2 or Above Radiation-induced Lung Injury
ClinicalTrials.gov ID
NCT02296281
Lead Sponsor
Beijing Continent Pharmaceutical Co, Ltd.INDUSTRY
Overall Status
Unknown status
Study Type
Interventional
Phase
Phase 2
Enrollment
48Estimated
Last Update Posted
Nov 20, 2014Estimated
Start Date
Jan 2015
Primary Completion Date
Jun 2016Estimated
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.
Radiation Pneumonitis
Pirfenidone
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-70 years old (include 18 and 70 years), male or female
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
General condition assessment, ECOG score of 0-1
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
The expected survival at 6 months or more
Subject is able to eat solid food
The initial radical thoracic radiotherapy treatment
The clinical diagnosis of radiation-induced lung injury in Grade 2 or above
The duration of radiation-induced lung injury in less than 1 month
Signed informed consent
Exclusion Criteria:
Radiation-induced lung injury has entered the chronic phase
A history of chronic bronchitis, emphysema, or a history of cor pulmonale
Lung resection surgery
Cancer progression
Pulmonary infection
Associated with other serious diseases: such as occurred within 6 months of myocardial infarction, uncontrolled diabetes etc.
With active peptic ulcer
Pregnant women and patients with mental disease
Those who participate in clinical trials of other drugs within 3 months
Investigator judge does not apply to participate in the trial