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New hope for lung injury: drug may repair radiation and immunotherapy damage

NCT ID NCT07388680

Disease control Sponsor: Beijing Continent Pharmaceutical Co, Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests if the drug pirfenidone can help people with lung damage caused by radiation therapy (with or without immunotherapy). About 298 adults with certain cancers who received chest radiation will take pirfenidone or a placebo for 24 weeks. The goal is to see if the drug improves lung function and helps people live longer.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 298 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

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: * 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.

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Conditions

The condition(s) this trial relates to.

pneumonitis radiation pneumonitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Immune-related pneumonia Radiation-induced lung injury

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    36 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Hospital of Fujian Medical University, Xiehe Branch

    RECRUITING

    Fuzhou, Fujian, China

  • Affiliated Hospital of Guangdong Medical UniversityAffiliated Hospital of Guangdong Medical University

    RECRUITING

    Zhanjiang, Guangdong, China

  • Anhui Provincial Chest Hospital

    RECRUITING

    Hefei, Anhui, China

  • Anyang City Cancer Hospital

    RECRUITING

    Anyang, Henan, China

  • Chinese Academy of Medical Sciences Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

  • Chinese Academy of Medical Sciences Cancer Hospital Shenzhen Branch

    RECRUITING

    Shenzhen, Guangdong, China

  • Foshan First Hospital

    RECRUITING

    Foshan, Guangdong, China

  • Fudan University Cancer Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • Fujian Provincial Cancer Hospital

    RECRUITING

    Fuzhou, Fujian, China

  • Gansu Provincial Cancer Hospital

    RECRUITING

    Gansu, Lanzhou, China

  • Gaozhou People's Hospital

    RECRUITING

    Maoming, Guangdong, China

  • Guangdong Provincial People's Hospital

    RECRUITING

    Guangzhou, Guangdong, China

  • Guangxi Medical University Cancer Hospital

    RECRUITING

    Nanning, Guangxi, China

  • Hebei University Affiliated Hospital

    RECRUITING

    Baoding, Hebei, China

  • Henan Provincial Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, China

  • Hubei Provincial Cancer Hospital

    RECRUITING

    Wuhan, Hubei, China

  • Hunan Provincial Cancer HospitalHunan Provincial Cancer Hospital

    RECRUITING

    Changsha, Wuhan, China

  • Jining First People's Hospital

    RECRUITING

    Jining, Shandong, China

  • Lanzhou University First Hospital

    RECRUITING

    Lanzhou, Gansu, China

  • Panyu Central Hospital Affiliated to Guangzhou Medical University

    RECRUITING

    Guangzhou, Guangdong, China

  • Shanghai Chest HospitalShanghai Chest Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • Shenzhen People's Hospital

    RECRUITING

    Shenzhen, Guangdong, China

  • Sichuan Provincial Cancer Hospital

    RECRUITING

    Chengdu, Sichuan, China

  • Southern Medical University - Southern Hospital

    RECRUITING

    Guangzhou, Guangdong, China

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, China

  • Taizhou Cancer Hospital

    RECRUITING

    Taizhong, Zhejiang, China

  • The First Affiliated Hospital of Guangzhou University of Chinese Medicine

    RECRUITING

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital of Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, China

  • The Second Affiliated Hospital of Zunyi Medical University

    RECRUITING

    Zunyi, Guizhou, China

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, China

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, China

  • West China Hospital of Sichuan University

    RECRUITING

    Chengdu, Sichuan, China

  • Xuzhou Medical University Affiliated Hospital

    RECRUITING

    Xuzhou, Jiangsu, China

  • Zhejiang Provincial Cancer HospitalZhejiang Provincial Cancer Hospital

    RECRUITING

    Hangzhou, Zhejiang, China

  • Zhongshan People's Hospital

    RECRUITING

    Zhongshan, Guangdong, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.