Radiation-induced Lung InjuryPhase 2NCT03902509
A Study About Safety and Efficacy of Pirfenidone to Treat Grade 2 or Grade3 Radiation-induced Lung Injury.
A Phase 2 study testing Pirfenidone and basic treatment in people with Radiation-induced Lung Injury, run by Beijing Continent Pharmaceutical Co, Ltd. at 2 sites in China.
Trial summary
Using Pirfenidone to treat Grade 2 or Grade3 radiation-induced lung injury, and observe the efficacy and safety of the drug. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Radiation-induced Lung Injury
- What is being tested?
- Pirfenidone and basic treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 2 sitesChina
- Study dates
- 24 May 2019to 4 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- 18-75 years old (including 18 and 75 years);
- clinically diagnosed grade 2 or 3 radiation-induced lung injury;
- the course of radiation-induced lung injury is less than 2 months;
- ECOG 0-2;
- the expected survival time is more than 6 months;
- the functional level of major organs meets the following standards: ANC≥3.0×109/L，PLT≥100×109/L，Hb≥90g/L, TBIL、BUN and Cr≤1.5×ULN， ALT、AST≤2.0×ULN
- capable of eating solid food upon enrollment;
- subjects will voluntarily participate in this study and sign the informed consent.
Who cannot join
- have a history of chronic bronchial acute attack or severe pulmonary heart disease;
- pneumonectomy;
- tumor progression;
- severe pulmonary infection;
- creatinine clearance rate < 30ml/min, severe renal disease or need dialysis;
- concomitant with other serious diseases: for example, myocardial infarction within 6 months, uncontrolled diabetes, etc., were considered not suitable for the participants in the study;
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- patients with active peptic ulcer;
- pregnant women and patients with mental illness;
- participating in clinical trials of other drugs within 3 months;
- the investigator determined that subject was not suitable.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
About this study
Official title: A Randomized, Controlled, Multi-site Study About Safety and Efficacy of Pirfenidone to Treat Grade 2 or Grade3 Radiation-induced Lung Injury.
Using Pirfenidone to treat Grade 2 or Grade3 radiation-induced lung injury, and observe the efficacy and safety of the drug.
Read the detailed description
The study is a randomized, controlled, multi-site clinical trial.
- Conditions
- Radiation-induced Lung Injury
- Being tested
- Pirfenidone, basic treatment
- Keywords
- pirfenidone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PirfenidoneDrug
pirfenidone capsule made in China
basic treatmentDrug
glucocorticoid and expectant treatment etc.
| Study group | Role | What they receive |
|---|---|---|
| Pirfenidone | Experimental | pirfenidone + basic treatment Receives: Drug: Pirfenidone; Drug: basic treatment |
| Controll | Other | with basic treatment and without pirfenidone treatment Receives: Drug: basic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLco% change
Compare DLco% from basement to the end of treatment
Measured: Week 4, 8,16, and 24
Secondary outcomes (4)
The grade change of radiation-induced lung injury
Measured: Week 4, 8,16, and 24
The score change of CT
Measured: Week 4, 8,16, and 24
Increase of effective lung volume
Measured: Week 4, 8,16, and 24
The grade change of Cough, Dyspnea and Fever
Measured: Week 4, 8,16, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start24 May 2019
- Primary completion4 Dec 2023
- Study completion4 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902509
- Sponsor's protocol ID
- RP-F647-201901
- Status last verified
- Dec 2023
- First submitted
- 2 Apr 2019
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hou Z, Dong B, Yao Q, Chen H, Shao Q, Li M, Wang J, Chen K, Zhu Z, Peng F, Wei S, Hu X, Li J, Liu M, Xu B, Zheng S, Bi N, Zheng S, Xu Q, Chen B, Wu C, Li R, Chen W, Liu X, Tian Y, Li X, Guo S, Zhao L, Zhu Y, Cai L, Li Q, Li L, Zhang H, Hu C, Wang L, Li Q, Chen B, Chen M. Pirfenidone for grade 2 and grade 3 radiation-induced lung injury: a multicentre, open-label, randomised, phase 2 trial. Lancet Oncol. 2025 Dec;26(12):1552-1562. doi: 10.1016/S1470-2045(25)00515-7. Epub 2025 Nov 6.
PubMed 41207313
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Multi-site Study About Safety and Efficacy of Pirfenidone to Treat Grade 2 or Grade3 Radiation-induced Lung Injury.
- ClinicalTrials.gov ID
- NCT03902509
- Acronym / sponsor ID
- RP-F647-201901
- Conditions
- Radiation-induced Lung Injury
- Keywords
- pirfenidone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 May 2019 (actual)
- Primary completion
- 4 Dec 2023 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 4 Apr 2019 (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.
Using Pirfenidone to treat Grade 2 or Grade3 radiation-induced lung injury, and observe the efficacy and safety of the drug.
Detailed description
The study is a randomized, controlled, multi-site clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pirfenidone | Experimental | Drug: Pirfenidone, Drug: basic treatmentpirfenidone + basic treatment |
| Controll | Other | Drug: basic treatmentwith basic treatment and without pirfenidone treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18-75 years old (including 18 and 75 years);
- clinically diagnosed grade 2 or 3 radiation-induced lung injury;
- the course of radiation-induced lung injury is less than 2 months;
- ECOG 0-2;
- the expected survival time is more than 6 months;
Key exclusion criteria (10 listed)
- have a history of chronic bronchial acute attack or severe pulmonary heart disease;
- pneumonectomy;
- tumor progression;
- severe pulmonary infection;
- creatinine clearance rate < 30ml/min, severe renal disease or need dialysis;
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 |
|---|---|---|
| Pirfenidonepirfenidone capsule made in China | Drug | Pirfenidone |
| basic treatmentglucocorticoid and expectant treatment etc. | Drug | Controll, Pirfenidone |
Primary outcome
DLco% change
Time frame: Week 4, 8,16, and 24
Compare DLco% from basement to the end of treatment
4 secondary outcomes
The grade change of radiation-induced lung injury
Time frame: Week 4, 8,16, and 24
The score change of CT
Time frame: Week 4, 8,16, and 24
Increase of effective lung volume
Time frame: Week 4, 8,16, and 24
The grade change of Cough, Dyspnea and Fever
Time frame: Week 4, 8,16, and 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Derived from this study: PubMed 41207313Hou Z, Dong B, Yao Q, Chen H, Shao Q, Li M, Wang J, Chen K, Zhu Z, Peng F, Wei S, Hu X, Li J, Liu M, Xu B, Zheng S, Bi N, Zheng S, Xu Q, Chen B, Wu C, Li R, Chen W, Liu X, Tian Y, Li X, Guo S, Zhao L, Zhu Y, Cai L, Li Q, Li L, Zhang H, Hu C, Wang L, Li Q, Chen B, Chen M. Pirfenidone for grade 2 and grade 3 radiation-induced lung injury: a multicentre, open-label, randomised, phase 2 trial. Lancet Oncol. 2025 Dec;26(12):1552-1562. doi: 10.1016/S1470-2045(25)00515-7. Epub 2025 Nov 6.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pirfenidone and basic treatment in people with Radiation-induced Lung Injury, run by Beijing Continent Pharmaceutical Co, Ltd. at 2 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 8 inclusion and 10 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: finished, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLco% change (time frame: Week 4, 8,16, and 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03902509, which also lists 1 linked publication.
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 4 May 2025.