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

Beijing Continent Pharmaceutical

Status and phase: Unknown; Phase 2

Conditions: Radiation Pneumonitis

Treatments: Drug: Pirfenidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT02296281

GNI-F647-1401

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

treatment group

Experimental group

Treatment:

Drug: Pirfenidone