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

Radiation Pneumonitis Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02296281
• Other study ID #: GNI-F647-1401
• Status: Not yet recruiting
• Phase: Phase 2
• First received: November 18, 2014
• Last updated: November 19, 2014
• Start date: January 2015

Study information

• Verified date: November 2014
• Source: Beijing Continent Pharmaceutical Co, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Radiation Pneumonitis

Intervention

Drug:
• Pirfenidone

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Beijing Continent Pharmaceutical Co, Ltd.	GNI-EPS Pharmaceuticals, Inc. (GNI Group), Shanghai Genomics, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in radiation-induced lung injury classification		36 Weeks	Yes