Can an Anti-Fibrotic drug shield lungs from radiation after immunotherapy?
NCT ID NCT05801133
First seen Sep 18, 2026 · Last updated Sep 18, 2026
Summary
Researchers are testing whether pirfenidone, a drug that reduces inflammation and scarring, can prevent radiation pneumonitis in people with advanced lung cancer. Participants have already received immune checkpoint inhibitors and need chest radiation. The trial gives pirfenidone alongside radiation to see if it lowers the rate of moderate to severe lung inflammation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pirfenidone, an anti-inflammatory and anti-fibrotic drug
- What this could lead to
- If it works, pirfenidone could become a way to protect the lungs of lung cancer patients who need chest radiation after immunotherapy, letting them receive treatment with fewer breathing complications.
- What could go wrong
- This is a small, single-arm phase 2 study with 41 participants and no control group, so any benefit seen may not hold up in larger randomized trials. Pirfenidone can cause nausea, rash, and liver problems, and it may not prevent lung injury in this specific group.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
41 people
The number who actually took part.
- Started
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Mar 2023
- Finished
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Oct 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. The patients joined the study voluntarily and signed an informed consent form (ICF). They had good compliance and cooperated with follow-up; 2. Patients with lung cancer who had received at least 2 cycles of immunomonotherapy or combination systemic therapy (including PD-1 or PD-L1 immunocheckpoint inhibitors) within 6 months; 3. Age ≥ 18 years, no gender limit; 4. ECOG PS score: 0~1; 5. The expected survival time ≥ 3 months; 6. Use appropriate methods of contraception or surgical sterilization during treatment and for 3 years after treatment for men and women of reproductive age; 7. Appropriate biochemical indicators and organ function. Exclusion Criteria: 1. Currently participating in interventional clinical research and treatment, or receiving other research drugs or treatment with research equipment within 4 weeks before the first administration; 2. Accept solid organ or blood system transplantation; 3. Suffer from active autoimmune diseases that require hormone or immunomodulatory treatment, such as rheumatoid arthritis, ankylosing spondylitis, type I diabetes, psoriasis, vitiligo, immune-related thyroid dysfunction, etc. (hormone replacement Can be included after treatment is normal); 4. Suffer from acute or chronic infectious diseases, such as hepatitis B, hepatitis C, tuberculosis, and HIV; 5. Allergic to research drug ingredients; 6. Active infection or fever of unknown cause occurred during the screening period and before the first administration\> 38.5℃ (according to the judgment of the investigator, the subject can be included in the group due to fever caused by the tumor); 7. Suffer from uncontrolled clinical symptoms or diseases of the heart, such as:(1) Heart failure above NYHA II; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year; (4) Patients with clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention; 8. Suffer from high blood pressure and cannot be well controlled by antihypertensive medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg); 9. Abnormal blood coagulation function (INR\>2.0, PT\>16s), have a bleeding tendency or are receiving thrombolytic therapy, and allow preventive use of low-dose aspirin and low-molecular-weight heparin; 10. Obvious coughing up blood or hemoptysis of 10ml or more per day in the 2 months before enrollment; 11. Have significant clinically significant bleeding symptoms or have a clear bleeding tendency within 3 months before enrollment; 12. Have received anti-tumor monoclonal antibodies (mAb) within 4 weeks before using the study drug for the first time, or the adverse events caused by the previously received drug have not recovered (ie ≤ grade 1 or reached the baseline level). Note: Except for subjects with ≤ Grade 2 neuropathy or ≤ Grade 2 hair loss, if the subject has undergone major surgery, the toxic reaction and/or complications caused by the surgical intervention must be fully recovered before starting treatment; 13. The investigator judged other situations not suitable for inclusion in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
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