Pifenidone Prophylactic Therapy for Radiation Lung Injury in Patients Who Have Previously Received Immune Checkpoint Inhibitors

NCT05801133 | Recruiting Phase 2

• 1 other identifier: HBRT-2023-01
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with advanced lung cancer who have previously received immunocheckpoint inhibitor therapy, undergone chest radiation therapy again have developed radiation induced lung injury. Pirfenidone has anti-inflammatory and anti fibrosis effects. This study is intended to evaluate the effectiveness of pirfenidone combined with radiotherapy in the prevention of radiation pneumonitis.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence rate of radiation pneumonia ≥ grade 2 (1 month, 3 month, 6 month)

  Incidence rate of radiation pneumonia ≥ grade 2 (1 month, 3 month, 6 month)

  up to 6 month

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  up to 6 month

• Disease Control Rate （DCR）

  up to 6 month

• 6 month progression-free-survival (PFS) rate

  up to 6 month

• Treatment-related adverse events

  up to 6 month

Study Arms (1)

Pirfenidone combined with radiotherapy

EXPERIMENTAL

Pirfenidone: synchronized with RT, 200 mg TID in the first week, 300 mg TID in the second week, and maintenance treatment of 400 mg TID from the third week until 3 months Radiotherapy: no limitation, TD≥50Gy (BED/ α/β： 10）

Drug: Pirfenidone

Interventions

Pirfenidone DRUG

200 mg TID in the first week, 300 mg TID in the second week, and maintenance treatment of 400 mg TID from the third week until 3 months

Also known as: PFD, AiSiRui

Pirfenidone combined with radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients joined the study voluntarily and signed an informed consent form (ICF). They had good compliance and cooperated with follow-up;
• 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;
• Age ≥ 18 years, no gender limit;
• ECOG PS score: 0～1;
• The expected survival time ≥ 3 months;
• Use appropriate methods of contraception or surgical sterilization during treatment and for 3 years after treatment for men and women of reproductive age；
• Appropriate biochemical indicators and organ function.

You may not qualify if:

• 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;
• Accept solid organ or blood system transplantation;
• 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);
• Suffer from acute or chronic infectious diseases, such as hepatitis B, hepatitis C, tuberculosis, and HIV;
• Allergic to research drug ingredients;
• 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);
• 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;
• Suffer from high blood pressure and cannot be well controlled by antihypertensive medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg);
• 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;
• Obvious coughing up blood or hemoptysis of 10ml or more per day in the 2 months before enrollment;
• Have significant clinically significant bleeding symptoms or have a clear bleeding tendency within 3 months before enrollment;
• 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;

Sponsors & Collaborators

• Hubei Cancer Hospital: lead

Study Sites (1)

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

pirfenidone

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Guang Han, MD,PhD

CONTACT

13886048178; hg7913@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 6, 2023
• Study Start: March 31, 2023
• Primary Completion: March 31, 2025
• Study Completion: September 1, 2025
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)