Radiation-induced Lung InjuryPhase 2/3NCT07388680
Pirfenidone Capsules in the Treatment of Radiation-induced Lung Injury With or Without Immune Pneumonia
A Phase 2/3 study testing Pirfenidone Capsules （400 mg）, Pirfenidone Capsules（600mg） and Pirfenidone Capsules（0mg） in people with Radiation-induced Lung Injury and Immune-related Pneumonia, run by Beijing Continent Pharmaceutical Co, Ltd. at 36 sites in China.
Trial summary
Radiation-induced lung injury (RILI) is one of the most common thoracic-radiotherapy complications, with an incidence as high as 31.4 %. Multiple studies have shown that RILI can adversely affect patient prognosis by disrupting treatment schedules. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Radiation-induced Lung Injury, Immune-related Pneumonia
- What is being tested?
- Pirfenidone Capsules （400 mg）, Pirfenidone Capsules（600mg） and Pirfenidone Capsules（0mg）
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 298 participants
- Where
- 36 sitesChina
- Study dates
- 26 Mar 2026to 30 Dec 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects must meet all the following inclusion criteria to be enrolled in this study:
- Voluntary signing of the informed consent form, and being capable of understanding and signing the informed consent form before the study.
- Age 18 to 75 years (inclusive of 18 and 75), with no gender restrictions.
- Malignant tumors diagnosed by pathological histology/cytology, and having received radiotherapy to the chest.
- According to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 standard, diagnosed by the investigator as clinical RILI grade 2-3 with or without CIP. For those with CIP, the investigator determines that only hormone treatment is required.
- At the time of enrollment, 40% ≤ DLCO as a percentage of the predicted value < 80% (mild to moderate lung diffusion function impairment).
Show all 16Show fewer
- The course of radiation-induced lung injury is less than 2 months.
- If receiving radiation-induced lung injury-related treatment (including glucocorticoids, antibiotics, etc.) at the time of enrollment, the types and doses of medication must remain stable within 2 weeks before enrollment, and the hormone medication does not exceed 4 weeks.
- At the time of enrollment, the investigator assesses that the subjects can take oral administration of the investigational drug.
- Eastern Cooperative Oncology Group score (ECOG) 0-2.
- Expected survival period ≥ 6 months.
- The functional level of major organs meets the following standards:
- Blood routine examination: Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count (PLT) ≥ 75 × 109/L or hemoglobin (Hb) ≥ 90 g/L;
- Biochemical examination: Total bilirubin (TBIL), blood urea nitrogen (BUN), and creatinine (Cr) ≤ 1.5 upper limit of normal value (ULN), or creatinine clearance rate ≥ 50 mL/min; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.0 ULN.
- Creatinine clearance rate = [(140 - age) × weight (kg)] / [0.818 × Scr (umol/L)] (for females × 0.85)
- For all fertile women, the serum pregnancy test within 7 days before the first administration must be negative, and fertile male and female subjects must agree to use reliable contraceptive methods (hormonal or barrier method or abstinence) with their partners during the entire study period and at least 6 months after the last use of the investigational drug.
Who cannot join
- Subjects with Child-Pugh grade C at the time of enrollment or with severe liver diseases such as liver failure, hepatic encephalopathy, etc.
- Subjects who have had Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug eruption with eosinophilia and systemic symptoms (DRESS), or severe skin diseases in the past or currently;
- Subjects who have other diseases that the investigator deems unsuitable for participation in this study during the screening process.
- Subjects with active untreated brain metastases or meningeal metastases; for subjects with treated central nervous system (CNS) metastases, if the symptoms are controlled for at least 4 weeks, they are eligible for enrollment;
- Subjects who have a second malignancy that requires concurrent systemic cytotoxic chemotherapy, investigational treatment or biological therapy (such as anti-cytotoxic T lymphocyte-associated protein 4 [CTLA4] or human epidermal growth factor receptor 2 [HER2] monoclonal antibodies), but are allowed to enroll if they have a second malignancy that only requires hormone therapy (such as gonadotropin-releasing hormone [LHRH] agonists, tamoxifen, etc.);
- Subjects with a history of human immunodeficiency virus (HIV) infection, or positive HIV antibodies or suspected HIV infection.
Show all 19Show fewer
- Subjects who cannot discontinue tetracycline antibiotics (such as doxycycline, minocycline, etc.) within 14 days before screening or during the study.
- Subjects who the investigator deems unable to follow the testing procedures (such as being unable to tolerate the interruption of assisted oxygen supply during pulmonary function tests).
- Subjects who have used or are to use drugs that may have preventive and/or therapeutic effects on radiation pneumonitis within 1 month before screening or during the study, such as pentoxifylline, angiotensin-converting enzyme inhibitors, berberine, ursolic acid, statins, nicorandil, stem cells, interferon-γ, penicillamine, etc.;
- Subjects who have used nintedanib or high-dose acetylcysteine within 1 month before randomization;
- Subjects who have used known or judged by the investigator to be beneficial to lung injury Chinese herbal medicines or other substances during the 1 month before randomization;
- Subjects who have received or been exposed to live vaccines or attenuated live vaccines or plan to receive live vaccines or attenuated live vaccines (except anti-tumor treatment live vaccines) during the study;
- Subjects who have used drugs that are strong inhibitors or inducers of cytochrome CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1 within 1 month before screening or during the study;
- Female subjects who are breastfeeding at the time of screening or male subjects whose partner is planning to get pregnant during the study.
- Subjects with known mental disorders that may affect the study assessment or with poor compliance.
- Subjects who are allergic to any active ingredients of this drug or its excipients (such as lactose) or lactose intolerant.
- Subjects who had severe trauma or received surgery within 1 month before screening or during the study, or who plan to undergo surgery during the study.
- Subjects who, according to the investigator's judgment, have other serious systemic diseases or laboratory test abnormalities or other reasons that make them unsuitable for participating in this clinical trial.
- Subjects who plan to participate in other drug clinical trials during the study.
Trial locations and contacts
36 sites in 1 country. Contact the study team or a site near you to ask about taking part.
36 sites in 1 country
China36 sites, 36 recruiting
- Recruiting
Anyang City Cancer Hospital
Anyang, Henan
Anping Zheng
- Recruiting
Hebei University Affiliated Hospital
Baoding, Hebei
Hongyun Shi
- Recruiting
Chinese Academy of Medical Sciences Cancer Hospital
Beijing, Beijing Municipality
Nan Bi
- Recruiting
Hunan Provincial Cancer HospitalHunan Provincial Cancer Hospital
Changsha, Wuhan
Hui Wang
- Recruiting
Sichuan Provincial Cancer Hospital
Chengdu, Sichuan
Qifeng Wang
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
Jianxin / Lin Xue / Zhou
- Recruiting
Foshan First Hospital
Foshan, Guangdong
Rong Huang
- Recruiting
Affiliated Hospital of Fujian Medical University, Xiehe Branch
Fuzhou, Fujian
Benhua Xu
- Recruiting
Fujian Provincial Cancer Hospital
Fuzhou, Fujian
Jiancheng Li
- Recruiting
Gansu Provincial Cancer Hospital
Gansu, Lanzhou
Shihong Wei
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Yi Pan
- Recruiting
Panyu Central Hospital Affiliated to Guangzhou Medical University
Guangzhou, Guangdong
Jiazhuo Hu
- Recruiting
Southern Medical University - Southern Hospital
Guangzhou, Guangdong
Jian Guan
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Ming Chen
- Recruiting
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong
Linzhuo Zhai
- Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Yong Bao
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Qichun Wei
- Recruiting
Zhejiang Provincial Cancer HospitalZhejiang Provincial Cancer Hospital
Hangzhou, Zhejiang
Yongling Ji
- Recruiting
Anhui Provincial Chest Hospital
Hefei, Anhui
XuHong Min
- Recruiting
Jining First People's Hospital
Jining, Shandong
Leilei Yuan
- Recruiting
Lanzhou University First Hospital
Lanzhou, Gansu
Juntao Ran
- Recruiting
Gaozhou People's Hospital
Maoming, Guangdong
Zunbei Wen
- Recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi
Long Cheng
- Recruiting
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality
Zhengfei Zhu
- Recruiting
Shanghai Chest HospitalShanghai Chest Hospital
Shanghai, Shanghai Municipality
Wen Yu
- Recruiting
Chinese Academy of Medical Sciences Cancer Hospital Shenzhen Branch
Shenzhen, Guangdong
Lvhua Wang
- Recruiting
Shenzhen People's Hospital
Shenzhen, Guangdong
Zihuang Li
- Recruiting
Taizhou Cancer Hospital
Taizhong, Zhejiang
Yujin Xu
- Recruiting
Hubei Provincial Cancer Hospital
Wuhan, Hubei
Guang Han
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Qian Chu
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Rui Meng
- Recruiting
Xuzhou Medical University Affiliated Hospital
Xuzhou, Jiangsu
Xin Ding
- Recruiting
Affiliated Hospital of Guangdong Medical UniversityAffiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong
Huailin Chen
- Recruiting
Henan Provincial Cancer Hospital
Zhengzhou, Henan
Hong Ge
- Recruiting
Zhongshan People's Hospital
Zhongshan, Guangdong
Minying Li
- Recruiting
The Second Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou
Yuju Bo
About this study
Official title: 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
Radiation-induced lung injury (RILI) is one of the most common thoracic-radiotherapy complications, with an incidence as high as 31.4 %. Multiple studies have shown that RILI can adversely affect patient prognosis by disrupting treatment schedules. Moreover, the widespread clinical use of immune-checkpoint inhibitors (ICIs) has further increased pulmonary toxicity when radiotherapy (RT) is combined with ICIs. Checkpoint-inhibitor-related pneumonitis (CIP)-i.e., immune-mediated lung injury-may necessitate permanent discontinuation of ICIs, diminish survival benefit, and, in severe cases, directly threaten life. The diagnosis of both RILI and CIP is based on an integrated assessment of subjective symptoms and imaging findings.RILI typically occurs 1-3 months after completion of radiotherapy, whereas CIP may emerge at any point during treatment. The two entities share similar clinical presentations: fever, dry cough, chest tightness, dyspnoea, and pleuritic chest pain. Computed tomography (CT) is the most sensitive imaging modality. Pulmonary-function testing is another routinely used clinical metric; vital capacity, total lung capacity, forced expiratory volume in 1 s (FEV₁), and diffusing capacity of the lung for carbon monoxide (DLCO) may all decline, with DLCO being the most sensitive parameter. In advanced cases, arterial oxygen and carbon-dioxide tensions may also deteriorate.Currently, RILI is managed empirically with systemic corticosteroids and supportive care; however, this approach yields limited improvement in diffusing capacity or ventilatory function, and its ability to prevent radiation-induced pulmonary fibrosis (RPF) remains undefined. Corticosteroids also remain the mainstay of CIP therapy. Pirfenidone, a potent cytokine inhibitor, attenuates fibroblast activity by reducing production of transforming growth factor-β1 (TGF-β1), platelet-derived growth factor (PDGF), and fibroblast growth factor (FGF), thereby suppressing fibroblast proliferation and extracellular-matrix collagen synthesis. Pre-clinical efficacy studies have demonstrated robust anti-inflammatory, anti-oxidant, and anti-fibrotic effects in the lung.Because RILI and pneumonitis arising from combined radio-immunotherapy are often indistinguishable in clinical practice, and because both share pathogenetic features with idiopathic pulmonary fibrosis (IPF), the investigators initiated this phase II/III trial to address the unmet medical need for effective therapy. Building on prior pre-clinical and clinical data, the study aims to establish the optimal dose of pirfenidone capsules for RILI with or without concomitant CIP and to confirm efficacy and safety.Phase II (dose-finding): The study consists of a screening period (Day -28 to Day -1), a 168-day treatment-observation period (Day 1-Day 168), a safety follow-up (28 ± 7 days after the last dose), and subsequent disease-progression and survival follow-up. Ninety subjects with RILI, with or without CIP, who meet all eligibility criteria will be randomly assigned 1:1:1 to low-dose pirfenidone (400 mg TID), high-dose pirfenidone (600 mg TID), or matching placebo.Phase III (confirmatory): The dose of pirfenidone capsules for phase III will be determined jointly by the sponsor and investigators based on accumulated efficacy and safety data. The trial structure mirrors phase II: screening (Day -28 to Day -1), 168-day treatment-observation (Day 1-Day 168), safety follow-up (28 ± 7 days after the last dose), and disease-progression and survival follow-up. Eligible subjects with RILI ± CIP will be randomized 1:1 to receive either pirfenidone capsules (400 mg or 600 mg TID, taken with meals) or identical placebo. After completion of the 28-day post-treatment follow-up, all phase III participants will enter an extension phase for long-term survival assessment every 3 months (± 7 days).This trial will investigate the progression-free survival (PFS) and overall survival (OS) associated with pirfenidone capsules in patients with Grade 2 and 3 radiation-induced lung injury (RILI), with or without chemotherapy-induced pneumonitis (CIP).
- Being tested
- Pirfenidone Capsules （400 mg）, Pirfenidone Capsules（600mg）, Pirfenidone Capsules（0mg）
- Keywords
- Radiation-induced lung injury, Immune-related pneumonia, RILI, CIP, Pirfenidone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pirfenidone Capsules （400 mg）Drug
Low-dose group:400 mg, TID
Pirfenidone Capsules（600mg）Drug
Pirfenidone Capsules（600mg，TID）
Pirfenidone Capsules（0mg）Drug
Placebo（0mg，TID）
| Study group | Role | What they receive |
|---|---|---|
| Low-dose group | Experimental | Pirfenidone Capsules (Low-dose group: 400 mg, TID) Receives: Drug: Pirfenidone Capsules （400 mg） |
| High-dose group | Experimental | Pirfenidone Capsules (High-dose group: 600 mg, TID) Receives: Drug: Pirfenidone Capsules（600mg） |
| Placebo group | Placebo comparator | Pirfenidone Capsules（0mg，TID） Receives: Drug: Pirfenidone Capsules（0mg） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase II and Phase III: The absolute value of the change in the predicted percentage of lung carbon monoxide diffusion capacity (DLCO% predicted) from the baseline at week 24.
DLCO% is a core indicator for evaluating pulmonary gas exchange function, reflecting the efficiency of oxygen transfer from the alveoli into the bloodstream. It is crucial for the diagnosis and prognosis of interstitial lung disease, pulmonary vascular disease, and similar conditions. DLCO% = measured diffusing capacity of the lung for carbon monoxide ÷ predicted value × 100%. Absolute value change refers to the direct difference between two consecutive measurements (for example, a decrease from 65% to 55% represents an absolute value change of -10%).
Measured: At the 24th week of the experiment
Secondary outcomes (29)
Phase II and Phase III: The absolute values of the changes in DLCO% at weeks 2, 4, 8, and 16 compared to the baseline.
Measured: At weeks 2, 4, 8 and 16 of the trial
Phase II and III: Compared with the baseline, the changes in the measured values of pulmonary carbon monoxide diffusion capacity (DLCO) (in units of liters [L]) at weeks 2, 4, 8, 16, and 24.
Measured: At weeks 2, 4, 8,16 and 24 of the trial
Phase II and Phase III: Changes in forced vital capacity (FVC) (in liters) from baseline at weeks 2, 4, 8, 16, and 24.
Measured: At weeks 2, 4, 8,16 and 24 of the trial
Phase II and Phase III: The absolute value changes of forced vital capacity as a percentage of the predicted value (FVC%) from baseline at weeks 2, 4, 8, 16, and 24.
Measured: At weeks 2, 4, 8,16 and 24 of the trial
Phase II and Phase III: Changes in forced expiratory volume in one second (FEV1) (in liters) from baseline at weeks 2, 4, 8, 16, and 24.
Measured: At weeks 2, 4, 8,16 and 24 of the trial
Phase II and Phase III: The absolute value of the change in forced expiratory volume in one second as a percentage of the predicted value (FEV1%) from baseline at weeks 2, 4, 8, 16, and 24.
Measured: At weeks 2, 4, 8,16 and 24 of the trial
Phase II and Phase III: Changes in FEV1/FVC from baseline at weeks 2, 4, 8, 16, and 24.
Measured: At weeks 2, 4, 8,16 and 24 of the trial
Phase II and Phase III: Changes in the St. George's Respiratory Questionnaire (SGRQ) scores from baseline at weeks 4, 8, 16, and 24.
The St. George's Respiratory Questionnaire (SGRQ) score is the standard instrument for assessing health-related quality of life in patients with chronic airway diseases. It comprises 76 items grouped into three domains-symptoms, activity, and disease impact. Each domain score and the overall total score are scaled from 0 to 100: 0 denotes "complete absence of symptoms or limitation," whereas 100 indicates "maximal severity." Higher scores signify a greater adverse effect of the disease on daily life.
Measured: At weeks 4, 8,16 and 24 of the trial
Phase II and Phase III: Changes in cough score from baseline at weeks 2, 4, 8, 16, and 24.
The cough score is a subjective instrument that quantifies the frequency, intensity, and disruptive impact of cough on daily activities and sleep into a 0-10-point or 0-100-mm scale; zero denotes complete absence of cough, and higher values indicate increasing symptom severity.
Measured: At weeks 2, 4, 8,16 and 24 of the trial
Phase II and Phase III: Changes in the Modified Medical Research Council Dyspnea Scale (mMRC) score at weeks 2, 4, 8, 16, and 24 compared to the baseline.
The Modified Medical Research Council Dyspnea Scale (mMRC) is a five-level instrument that rapidly quantifies the extent to which breathlessness limits physical activity; higher grades indicate greater disability.
Measured: At weeks 2, 4, 8,16 and 24 of the trial
Phase II and Phase III: Compared with the baseline, the changes in computed tomography (CT) imaging scores at weeks 4, 8, 16, and 24
CT imaging score is a standardized method that converts anatomical or functional features observed on CT scans into quantifiable numerical values, used for disease diagnosis, staging, treatment response monitoring, or prognostic assessment.Referring to the HRCT scoring system, the scores were assigned by imaging experts after consensus , with higher values generally indicating more severe disease.
Measured: At weeks 4, 8,16 and 24 of the trial
Phase II and Phase III: The proportion of subjects with CIP at baseline who discontinued immunotherapy and experienced immune reactivation during the study period.
Measured: Within 24 weeks
Phase II and Phase III: The proportion of subjects whose lung injury grade decreased by at least one level compared to the baseline at week 24.
According to the Common Terminology Criteria for Adverse Events, Version 5.0, pulmonary injury is graded, with higher grades indicating more severe symptoms.
Measured: Within 24 weeks
Phase II and Phase III: The proportion of subjects achieving a lung injury level of ≤ 1 at the 24th week compared to the baseline.
According to the Common Terminology Criteria for Adverse Events, Version 5.0, pulmonary injury is graded, with higher grades indicating more severe symptoms.
Measured: Within 24 weeks
Phase II and Phase III: The time required for the subjects to first achieve a lung injury level of ≤ 1.
According to the Common Terminology Criteria for Adverse Events, Version 5.0, pulmonary injury is graded, with higher grades indicating more severe symptoms.
Measured: Within 24 weeks
Phase II and Phase III: The proportion of subjects who experienced their first acute pulmonary deterioration or died for any reason within 24 weeks of treatment.
Acute pulmonary deterioration is defined as the unexplained worsening or new onset of cough, dyspnea, hypoxia, or pneumonia from the completion of initial treatment up to Week 24, persisting for >4 days, with chest CT showing new or increased diffuse pulmonary infiltrates in the absence of pneumothorax or pleural effusion, and after exclusion of pneumonia, congestive heart failure, pulmonary embolism, or cancer progression. Pulmonary deterioration occurring within the first 2 weeks after initial treatment is not counted toward the endpoint, allowing full resolution of initial symptoms.
Measured: Within 24 weeks
Phase II and Phase III: Analyze the blood drug concentration of pirfenidone capsules, evaluate the steady-state blood drug trough concentration for individual patients and each group of people at specific treatment time poin
Measured: on days 1, 14, 28, 56, 112, and 168 of the trial
Phase II and Phase III: Analyze the blood drug concentration of pirfenidone capsules, evaluate the PopPK characteristics for individual patients and each group of people at specific treatment time poin
Measured: on days 1, 14, 28, 56, 112, and 168 of the trial
Phase II and Phase III: Adverse events/serious adverse events (AE/SAE).
Adverse Event (AE) refers to any untoward and unintended medical occurrence experienced by a trial participant during treatment or clinical investigation, regardless of causal relationship to the investigational product. Serious Adverse Event (SAE) is a subset of AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, causes persistent or significant disability/incapacity, leads to congenital anomaly/birth defect, or is judged medically important by the investigator.
According to the Common Terminology Criteria for Adverse Events, Version 5.0, pulmonary injury is graded, with higher grades indicating more severe symptoms.
Measured: Within 24 weeks
Phase II and Phase III:Number of participants with abnormal ECG readings
Measured: At weeks 2, 4, 8,16 and 24 of the trial
Phase II and Phase III: vital signs( blood pressure).
Record patient's systolic and diastolic blood pressure
Measured: At weeks 2, 4, 8,16 and 24 of the trial
Phase II and Phase III: vital signs(pulse rate).
Measured: At weeks 2, 4, 8,16 and 24 of the trial
Phase II and Phase III: vital signs(body temperature).
Measured: At weeks 2, 4, 8, 16 and 24 of the trial
Phase II and Phase III: vital signs( respiratory rate data).
Measured: At weeks 2, 4, 8, 16 and 24 of the trial
Phase II and Phase III: laboratory tests（complete blood count).
Measured: At weeks 2, 4, 8, 16 and 24 of the trial
Phase II and Phase III: Number of participants with abnormal urinalysis
Measured: At weeks 2, 4, 8, 16 and 24 of the trial
Phase II and Phase III: Number of participants with abnormal laboratory tests results (blood biochemistry)
Measured: At weeks 2, 4, 8, 16 and 24 of the trial
Phase II and Phase III: Number of participants with abnormal laboratory tests results (coagulation function)
Measured: At weeks 2, 4, 8, 16 and 24 of the trial
Phase II and Phase III: laboratory tests( pregnancy test for safety assessment).
Measured: At weeks 2, 4, 8, 16 and 24 of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start26 Mar 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation-induced Lung InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 298 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sun Yat-sen University
- Responsible party
- Sponsor
- Investigators
- Ming Chen, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388680
- Sponsor's protocol ID
- KDN-F647-202401
- Status last verified
- Apr 2026
- First submitted
- 17 Nov 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07388680
- Acronym / sponsor ID
- KDN-F647-202401
- Keywords
- Radiation-induced lung injury, Immune-related pneumonia, RILI, CIP, Pirfenidone
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 298 participants (estimated)
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Sun Yat-sen University
- Study start
- 26 Mar 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Radiation-induced lung injury (RILI) is one of the most common thoracic-radiotherapy complications, with an incidence as high as 31.4 %. Multiple studies have shown that RILI can adversely affect patient prognosis by disrupting treatment schedules. Moreover, the widespread clinical use of immune-checkpoint inhibitors (ICIs) has further increased pulmonary toxicity when radiotherapy (RT) is combined with ICIs. Checkpoint-inhibitor-related pneumonitis (CIP)-i.e., immune-mediated lung injury-may necessitate permanent discontinuation of ICIs, diminish survival benefit, and, in severe cases, directly threaten life. The diagnosis of both RILI and CIP is based on an integrated assessment of subjective symptoms and imaging findings.RILI typically occurs 1-3 months after completion of radiotherapy, whereas CIP may emerge at any point during treatment. The two entities share similar clinical presentations: fever, dry cough, chest tightness, dyspnoea, and pleuritic chest pain. Computed tomography (CT) is the most sensitive imaging modality. Pulmonary-function testing is another routinely used clinical metric; vital capacity, total lung capacity, forced expiratory volume in 1 s (FEV₁), and diffusing capacity of the lung for carbon monoxide (DLCO) may all decline, with DLCO being the most sensitive parameter. In advanced cases, arterial oxygen and carbon-dioxide tensions may also deteriorate.Currently, RILI is managed empirically with systemic corticosteroids and supportive care; however, this approach yields limited improvement in diffusing capacity or ventilatory function, and its ability to prevent radiation-induced pulmonary fibrosis (RPF) remains undefined. Corticosteroids also remain the mainstay of CIP therapy. Pirfenidone, a potent cytokine inhibitor, attenuates fibroblast activity by reducing production of transforming growth factor-β1 (TGF-β1), platelet-derived growth factor (PDGF), and fibroblast growth factor (FGF), thereby suppressing fibroblast proliferation and extracellular-matrix collagen synthesis. Pre-clinical efficacy studies have demonstrated robust anti-inflammatory, anti-oxidant, and anti-fibrotic effects in the lung.Because RILI and pneumonitis arising from combined radio-immunotherapy are often indistinguishable in clinical practice, and because both share pathogenetic features with idiopathic pulmonary fibrosis (IPF), the investigators initiated this phase II/III trial to address the unmet medical need for effective therapy. Building on prior pre-clinical and clinical data, the study aims to establish the optimal dose of pirfenidone capsules for RILI with or without concomitant CIP and to confirm efficacy and safety.Phase II (dose-finding): The study consists of a screening period (Day -28 to Day -1), a 168-day treatment-observation period (Day 1-Day 168), a safety follow-up (28 ± 7 days after the last dose), and subsequent disease-progression and survival follow-up. Ninety subjects with RILI, with or without CIP, who meet all eligibility criteria will be randomly assigned 1:1:1 to low-dose pirfenidone (400 mg TID), high-dose pirfenidone (600 mg TID), or matching placebo.Phase III (confirmatory): The dose of pirfenidone capsules for phase III will be determined jointly by the sponsor and investigators based on accumulated efficacy and safety data. The trial structure mirrors phase II: screening (Day -28 to Day -1), 168-day treatment-observation (Day 1-Day 168), safety follow-up (28 ± 7 days after the last dose), and disease-progression and survival follow-up. Eligible subjects with RILI ± CIP will be randomized 1:1 to receive either pirfenidone capsules (400 mg or 600 mg TID, taken with meals) or identical placebo. After completion of the 28-day post-treatment follow-up, all phase III participants will enter an extension phase for long-term survival assessment every 3 months (± 7 days).This trial will investigate the progression-free survival (PFS) and overall survival (OS) associated with pirfenidone capsules in patients with Grade 2 and 3 radiation-induced lung injury (RILI), with or without chemotherapy-induced pneumonitis (CIP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-dose group | Experimental | Drug: Pirfenidone Capsules （400 mg）Pirfenidone Capsules (Low-dose group: 400 mg, TID) |
| High-dose group | Experimental | Drug: Pirfenidone Capsules（600mg）Pirfenidone Capsules (High-dose group: 600 mg, TID) |
| Placebo group | Placebo comparator | Drug: Pirfenidone Capsules（0mg）Pirfenidone Capsules（0mg，TID） |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- The subjects must meet all the following inclusion criteria to be enrolled in this study:
- Voluntary signing of the informed consent form, and being capable of understanding and signing the informed consent form before the study.
- Age 18 to 75 years (inclusive of 18 and 75), with no gender restrictions.
- Malignant tumors diagnosed by pathological histology/cytology, and having received radiotherapy to the chest.
- According to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 standard, diagnosed by the investigator as clinical RILI grade 2-3 with or without CIP. For those with CIP, the investigator determines that only hormone treatment is required.
Key exclusion criteria (19 listed)
- Subjects with Child-Pugh grade C at the time of enrollment or with severe liver diseases such as liver failure, hepatic encephalopathy, etc.
- Subjects who have had Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug eruption with eosinophilia and systemic symptoms (DRESS), or severe skin diseases in the past or currently;
- Subjects who have other diseases that the investigator deems unsuitable for participation in this study during the screening process.
- Subjects with active untreated brain metastases or meningeal metastases; for subjects with treated central nervous system (CNS) metastases, if the symptoms are controlled for at least 4 weeks, they are eligible for enrollment;
- Subjects who have a second malignancy that requires concurrent systemic cytotoxic chemotherapy, investigational treatment or biological therapy (such as anti-cytotoxic T lymphocyte-associated protein 4 [CTLA4] or human epidermal growth factor receptor 2 [HER2] monoclonal antibodies), but are allowed to enroll if they have a second malignancy that only requires hormone therapy (such as gonadotropin-releasing hormone [LHRH] agonists, tamoxifen, etc.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pirfenidone Capsules （400 mg）Low-dose group:400 mg, TID | Drug | Low-dose group |
| Pirfenidone Capsules（600mg）Pirfenidone Capsules（600mg，TID） | Drug | High-dose group |
| Pirfenidone Capsules（0mg）Placebo（0mg，TID） | Drug | Placebo group |
Primary outcome
Phase II and Phase III: The absolute value of the change in the predicted percentage of lung carbon monoxide diffusion capacity (DLCO% predicted) from the baseline at week 24.
Time frame: At the 24th week of the experiment
DLCO% is a core indicator for evaluating pulmonary gas exchange function, reflecting the efficiency of oxygen transfer from the alveoli into the bloodstream. It is crucial for the diagnosis and prognosis of interstitial lung disease, pulmonary vascular disease, and similar conditions. DLCO% = measured diffusing capacity of the lung for carbon monoxide ÷ predicted value × 100%. Absolute value change refers to the direct difference between two consecutive measurements (for example, a decrease from 65% to 55% represents an absolute value change of -10%).
29 secondary outcomes
Phase II and Phase III: The absolute values of the changes in DLCO% at weeks 2, 4, 8, and 16 compared to the baseline.
Time frame: At weeks 2, 4, 8 and 16 of the trial
Phase II and III: Compared with the baseline, the changes in the measured values of pulmonary carbon monoxide diffusion capacity (DLCO) (in units of liters [L]) at weeks 2, 4, 8, 16, and 24.
Time frame: At weeks 2, 4, 8,16 and 24 of the trial
Phase II and Phase III: Changes in forced vital capacity (FVC) (in liters) from baseline at weeks 2, 4, 8, 16, and 24.
Time frame: At weeks 2, 4, 8,16 and 24 of the trial
Phase II and Phase III: The absolute value changes of forced vital capacity as a percentage of the predicted value (FVC%) from baseline at weeks 2, 4, 8, 16, and 24.
Time frame: At weeks 2, 4, 8,16 and 24 of the trial
Phase II and Phase III: Changes in forced expiratory volume in one second (FEV1) (in liters) from baseline at weeks 2, 4, 8, 16, and 24.
Time frame: At weeks 2, 4, 8,16 and 24 of the trial
Phase II and Phase III: The absolute value of the change in forced expiratory volume in one second as a percentage of the predicted value (FEV1%) from baseline at weeks 2, 4, 8, 16, and 24.
Time frame: At weeks 2, 4, 8,16 and 24 of the trial
Phase II and Phase III: Changes in FEV1/FVC from baseline at weeks 2, 4, 8, 16, and 24.
Time frame: At weeks 2, 4, 8,16 and 24 of the trial
Phase II and Phase III: Changes in the St. George's Respiratory Questionnaire (SGRQ) scores from baseline at weeks 4, 8, 16, and 24.
Time frame: At weeks 4, 8,16 and 24 of the trial
Phase II and Phase III: Changes in cough score from baseline at weeks 2, 4, 8, 16, and 24.
Time frame: At weeks 2, 4, 8,16 and 24 of the trial
Phase II and Phase III: Changes in the Modified Medical Research Council Dyspnea Scale (mMRC) score at weeks 2, 4, 8, 16, and 24 compared to the baseline.
Time frame: At weeks 2, 4, 8,16 and 24 of the trial
Phase II and Phase III: Compared with the baseline, the changes in computed tomography (CT) imaging scores at weeks 4, 8, 16, and 24
Time frame: At weeks 4, 8,16 and 24 of the trial
Phase II and Phase III: The proportion of subjects with CIP at baseline who discontinued immunotherapy and experienced immune reactivation during the study period.
Time frame: Within 24 weeks
Phase II and Phase III: The proportion of subjects whose lung injury grade decreased by at least one level compared to the baseline at week 24.
Time frame: Within 24 weeks
Phase II and Phase III: The proportion of subjects achieving a lung injury level of ≤ 1 at the 24th week compared to the baseline.
Time frame: Within 24 weeks
Phase II and Phase III: The time required for the subjects to first achieve a lung injury level of ≤ 1.
Time frame: Within 24 weeks
Phase II and Phase III: The proportion of subjects who experienced their first acute pulmonary deterioration or died for any reason within 24 weeks of treatment.
Time frame: Within 24 weeks
Phase II and Phase III: Analyze the blood drug concentration of pirfenidone capsules, evaluate the steady-state blood drug trough concentration for individual patients and each group of people at specific treatment time poin
Time frame: on days 1, 14, 28, 56, 112, and 168 of the trial
Phase II and Phase III: Analyze the blood drug concentration of pirfenidone capsules, evaluate the PopPK characteristics for individual patients and each group of people at specific treatment time poin
Time frame: on days 1, 14, 28, 56, 112, and 168 of the trial
Phase II and Phase III: Adverse events/serious adverse events (AE/SAE).
Time frame: Within 24 weeks
Phase II and Phase III:Number of participants with abnormal ECG readings
Time frame: At weeks 2, 4, 8,16 and 24 of the trial
Phase II and Phase III: vital signs( blood pressure).
Time frame: At weeks 2, 4, 8,16 and 24 of the trial
Phase II and Phase III: vital signs(pulse rate).
Time frame: At weeks 2, 4, 8,16 and 24 of the trial
Phase II and Phase III: vital signs(body temperature).
Time frame: At weeks 2, 4, 8, 16 and 24 of the trial
Phase II and Phase III: vital signs( respiratory rate data).
Time frame: At weeks 2, 4, 8, 16 and 24 of the trial
Phase II and Phase III: laboratory tests（complete blood count).
Time frame: At weeks 2, 4, 8, 16 and 24 of the trial
Phase II and Phase III: Number of participants with abnormal urinalysis
Time frame: At weeks 2, 4, 8, 16 and 24 of the trial
Phase II and Phase III: Number of participants with abnormal laboratory tests results (blood biochemistry)
Time frame: At weeks 2, 4, 8, 16 and 24 of the trial
Phase II and Phase III: Number of participants with abnormal laboratory tests results (coagulation function)
Time frame: At weeks 2, 4, 8, 16 and 24 of the trial
Phase II and Phase III: laboratory tests( pregnancy test for safety assessment).
Time frame: At weeks 2, 4, 8, 16 and 24 of the trial
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
Related trials for Radiation-induced Lung Injury
RecruitingObservational study
Exploration of Whole-Brain Radiotherapy Combined With PD-1 Inhibitors on Brain Injury
Small Cell Lung Cancer ( SCLC ), Brain Injury
RecruitingPhase 2
PirfenidoneVsPlacebo as Prophylaxis Against Acute Radiation-induced Lung Injury Following HFRT in Breast Cancer Patients
Acute Lung Injury, Prevention
Active, not recruitingObservational study
Cardiotoxicity in Locally Advanced Lung Cancer Patients Treated With Chemoradiation Therapy
Cardiotoxicity, Lung Cancer Stage III
Active, not recruitingObservational study
Effects of Immune Checkpoint Inhibitors on Coronary Microvasculature
Coronary Microvascular Dysfunction, Cardiotoxicity
Not yet recruitingPhase 2
Early Prophylactic Versus Late Salvage Recombinant Human Endostatin in Managing Radiosurgery-Induced Brain Injury for NSCLC Brain Metastases
Lung Cancer (Non-Small Cell), Radiation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ming Chen principal investigator
Sun Yat-Sen University Cancer Center
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pirfenidone Capsules （400 mg）, Pirfenidone Capsules（600mg） and Pirfenidone Capsules（0mg） in people with Radiation-induced Lung Injury and Immune-related Pneumonia, run by Beijing Continent Pharmaceutical Co, Ltd. at 36 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming Chen (13600470913, chenming@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase II and Phase III: The absolute value of the change in the predicted percentage of lung carbon monoxide diffusion capacity (DLCO% predicted) from the baseline at week 24. (time frame: At the 24th week of the experiment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.