Can an Anti-Fibrotic drug shield lungs from radiation after immunotherapy?

NCT ID NCT05801133

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

Mar 2023

Finished

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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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