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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Continent Pharmaceutical Co, Ltd.
• Collaborators: GNI-EPS Pharmaceuticals, Inc. (GNI Group); Shanghai Genomics, Inc.
• Treatments: Pirfenidone

Criteria

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