Using Pirfenidone to Prevent Lung Injury from Radiation in Lung Cancer Patients

Pifenidone is Used to Reduce Radiation Lung Injury in Lung Cancer Patients Previously Treated With Immune Checkpoint Inhibitors: A Single-arm, Open-label, Phase II Study

This study is testing if the medication pirfenidone can help prevent lung damage from radiation in lung cancer patients who have recently received immunotherapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hubei Cancer Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT05801133 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of pirfenidone, an anti-inflammatory and anti-fibrotic medication, in preventing radiation pneumonitis in patients with advanced lung cancer who have previously received immune checkpoint inhibitors. Participants will receive pirfenidone in conjunction with chest radiation therapy to assess its ability to mitigate lung injury caused by radiation. The study focuses on patients who have undergone at least two cycles of immunotherapy within the last six months and have a good performance status. The goal is to improve patient outcomes by reducing the incidence of radiation-induced lung complications.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced lung cancer who have received prior immunotherapy and are scheduled for chest radiation.

Not a fit: Patients currently involved in other clinical trials or those with active autoimmune diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of radiation pneumonitis in lung cancer patients undergoing treatment.

How similar studies have performed: While the use of pirfenidone for radiation lung injury is a novel approach, similar studies have shown promise in using anti-inflammatory agents to mitigate radiation effects.

Eligibility criteria

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.

Where this trial is running

Wuhan, Hubei

• Hubei Cancer Hospital — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Guang Han, MD,PhD

Conditions Lung Cancer