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Pirfenidone for radiation-related and immune-related lung injury

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

Phase2; Phase3 Interventional Beijing Continent Pharmaceutical Co, Ltd. · NCT07388680

This trial will try pirfenidone capsules to treat adults who develop radiation-induced lung injury or immune checkpoint inhibitor–related pneumonitis.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment298 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorBeijing Continent Pharmaceutical Co, Ltd. Industry-sponsored
Drugs / interventionschemotherapy, radiation, immunotherapy
Locations36 sites (Hefei, Anhui and 35 other locations)
Trial IDNCT07388680 on ClinicalTrials.gov

What this trial studies

This phase 2/3 interventional trial tests oral pirfenidone at specified dose levels versus control in adults with CTCAE v5.0 grade 2–3 radiation‑induced lung injury, with or without steroid‑managed immune pneumonitis. Eligible participants must have had chest radiotherapy for cancer, have DLCO between 40% and less than 80% predicted, and a RILI course under two months. The multicenter trial conducted at several hospitals in China compares symptom changes, imaging, and lung function while monitoring safety and tolerability. Outcomes will determine whether pirfenidone reduces inflammation and fibrosis and helps preserve respiratory function.

Who should consider this trial

Good fit: Adults 18–75 with pathologically confirmed cancer who received chest radiotherapy and now have CTCAE v5.0 grade 2–3 radiation‑induced lung injury, with or without steroid‑managed immune pneumonitis and DLCO 40–<80%, are ideal candidates.

Not a fit: Patients with mild (grade 0–1) or very severe (grade 4–5) lung injury, DLCO below 40%, or those whose pneumonitis requires treatments beyond steroids are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, pirfenidone could reduce lung inflammation and scarring, potentially preserving lung function and allowing patients to continue cancer therapy with fewer respiratory complications.

How similar studies have performed: Pirfenidone is approved and effective for idiopathic pulmonary fibrosis, but evidence specifically for radiation‑induced lung injury or checkpoint‑inhibitor pneumonitis is limited and mainly from small or early‑phase reports.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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).
* 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:

  1. Blood routine examination: Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count (PLT) ≥ 75 × 109/L or hemoglobin (Hb) ≥ 90 g/L;
  2. 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.

Exclusion Criteria:

* 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.
* 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.

Where this trial is running

Hefei, Anhui and 35 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Radiation-induced Lung InjuryImmune-related PneumoniaRadiation-induced lung injuryImmune-related pneumoniaRILICIPPirfenidone
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.