Actively Recruiting
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II/III Clinical Trial on the Efficacy and Safety of Pirfenidone Capsules in the Treatment of Radiation-induced Lung Injury With or Without Immune-related Pneumonia
Led by Beijing Continent Pharmaceutical Co, Ltd. · Updated on 2026-04-22
298
Participants Needed
36
Research Sites
N/A
Total Duration
On this page
Sponsors
B
Beijing Continent Pharmaceutical Co, Ltd.
Lead Sponsor
S
Sun Yat-sen University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Radiation-induced lung injury (RILI) is a common complication after thoracic radiotherapy, occurring in about 31.4% of patients. This condition, sometimes combined with immune-checkpoint inhibitor-related pneumonitis (CIP), can disrupt cancer treatment and negatively affect patient outcomes. Both RILI and CIP share similar symptoms like fever, dry cough, and chest pain, and diagnosis involves symptom assessment and imaging such as computed tomography (CT). This trial aims to find the best dose and evaluate the safety and effectiveness of pirfenidone capsules for treating RILI with or without CIP, addressing a critical need for better therapies. The study has two phases: Phase II focuses on finding the optimal dose of pirfenidone, testing low-dose (400 mg three times daily), high-dose (600 mg three times daily), and placebo groups over 168 days of treatment and observation, followed by safety and survival follow-up. Phase III will confirm the chosen dose's effects compared to placebo with a similar schedule and includes a long-term extension phase with survival assessments every three months. Participants will receive oral pirfenidone capsules or placebo with meals during the treatment period. Participants will undergo regular assessments including lung function tests like diffusing capacity of the lung for carbon monoxide (DLCO), forced vital capacity (FVC), and forced expiratory volume in one second (FEV1). Other evaluations include symptom scores, CT imaging, blood tests, and monitoring for adverse events. The primary outcome is the change in lung diffusion capacity at 24 weeks. Safety follow-up occurs for about a month after treatment, and long-term monitoring continues in the extension phase. The total study participation spans from screening through treatment, safety follow-up, and extended survival tracking.
CONDITIONS
Brief Title
Pirfenidone Capsules in the Treatment of Radiation-induced Lung Injury With or Without Immune Pneumonia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signed informed consent and able to understand and sign the form
- Aged 18 to 75 years with no gender restrictions
- Diagnosed malignant tumors confirmed by pathology or cytology and received chest radiotherapy
- Diagnosed clinical radiation-induced lung injury (RILI) grade 2-3 with or without immune pneumonitis (CIP), requiring only hormone treatment for CIP
- Lung diffusion capacity (DLCO) between 40% and less than 80% of predicted value at enrollment
- Radiation-induced lung injury duration less than 2 months
- Stable doses of lung injury-related treatments for at least 2 weeks, with hormone treatment not exceeding 4 weeks
- Able to take oral investigational drug
- Eastern Cooperative Oncology Group (ECOG) score 0-2
- Expected survival of 6 months or more
- Adequate major organ function as defined by specified blood counts and biochemical measures
- Negative pregnancy test for fertile women and agreement to use contraception during study and 6 months after
You will not qualify if you...
- Child-Pugh grade C or severe liver diseases like liver failure or hepatic encephalopathy
- History or current severe skin diseases such as Stevens-Johnson syndrome or toxic epidermal necrolysis
- Any condition deemed unsuitable by investigator for participation
- Active untreated brain or meningeal metastases; controlled CNS metastases allowed if symptom-free for 4 weeks
- Second malignancies needing systemic chemotherapy or investigational/biological therapy, except hormone therapy
- HIV infection or suspected HIV
- Unable to discontinue tetracycline antibiotics within 14 days before or during study
- Unable to tolerate pulmonary function tests without assisted oxygen
- Use of drugs with preventive or therapeutic effects on radiation pneumonitis within 1 month before or during study
- Use of nintedanib, high-dose acetylcysteine, or beneficial lung injury Chinese medicines within 1 month before randomization
- Receipt or planned receipt of live or attenuated live vaccines during study (except anti-tumor vaccines)
- Use of strong cytochrome P450 enzyme inhibitors or inducers within 1 month before or during study
- Breastfeeding women or male partners planning pregnancy during study
- Known mental disorders affecting study compliance
- Allergy to study drug ingredients or lactose intolerance
- Severe trauma or surgery within 1 month before or during study or planned surgery
- Other serious systemic diseases or lab abnormalities deemed unsuitable
- Participation in other drug clinical trials during this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive Pirfenidone Capsules or placebo three times daily to treat radiation-induced lung injury with or without immune pneumonia.
Regular visits at weeks 2, 4, 8, 16, and 24
Trial Site Locations
Total: 36 locations
1
Anhui Provincial Chest Hospital
Hefei, Anhui, China
Actively Recruiting
2
Chinese Academy of Medical Sciences Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
3
Affiliated Hospital of Fujian Medical University, Xiehe Branch
Fuzhou, Fujian, China
Actively Recruiting
4
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
Actively Recruiting
5
Lanzhou University First Hospital
Lanzhou, Gansu, China
Actively Recruiting
6
Foshan First Hospital
Foshan, Guangdong, China
Actively Recruiting
7
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Actively Recruiting
8
Panyu Central Hospital Affiliated to Guangzhou Medical University
Guangzhou, Guangdong, China
Actively Recruiting
9
Southern Medical University - Southern Hospital
Guangzhou, Guangdong, China
Actively Recruiting
10
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
11
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
Actively Recruiting
12
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
13
Gaozhou People's Hospital
Maoming, Guangdong, China
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14
Chinese Academy of Medical Sciences Cancer Hospital Shenzhen Branch
Shenzhen, Guangdong, China
Actively Recruiting
15
Shenzhen People's Hospital
Shenzhen, Guangdong, China
Actively Recruiting
16
Affiliated Hospital of Guangdong Medical UniversityAffiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China
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17
Zhongshan People's Hospital
Zhongshan, Guangdong, China
Actively Recruiting
18
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Actively Recruiting
19
The Second Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
Actively Recruiting
20
Hebei University Affiliated Hospital
Baoding, Hebei, China
Actively Recruiting
21
Anyang City Cancer Hospital
Anyang, Henan, China
Actively Recruiting
22
Henan Provincial Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
23
Hubei Provincial Cancer Hospital
Wuhan, Hubei, China
Actively Recruiting
24
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
25
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
26
Xuzhou Medical University Affiliated Hospital
Xuzhou, Jiangsu, China
Actively Recruiting
27
Gansu Provincial Cancer Hospital
Gansu, Lanzhou, China
Actively Recruiting
28
Jining First People's Hospital
Jining, Shandong, China
Actively Recruiting
29
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
30
Shanghai Chest HospitalShanghai Chest Hospital
Shanghai, Shanghai Municipality, China
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31
Sichuan Provincial Cancer Hospital
Chengdu, Sichuan, China
Actively Recruiting
32
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
33
Hunan Provincial Cancer HospitalHunan Provincial Cancer Hospital
Changsha, Wuhan, China
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34
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
35
Zhejiang Provincial Cancer HospitalZhejiang Provincial Cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
36
Taizhou Cancer Hospital
Taizhong, Zhejiang, China
Actively Recruiting
Research Team
M
Ming Chen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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