search
Back to results

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

Primary Purpose

Lung Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Pirfenidone
Sponsored by
Hubei Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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; The investigator judged other situations not suitable for inclusion in this study.

Sites / Locations

  • Hubei Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pirfenidone combined with radiotherapy

Arm Description

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)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Objective Response Rate (ORR)
Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.
Disease Control Rate (DCR)
DCR was defined as the percentage of participants who have a confirmed complete response(CR) or partial response(PR) or stable disease(SD) per RECIST 1.1 as assessed by investigator
6 month progression-free-survival (PFS) rate
PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator
Treatment-related adverse events
overall incidence of adverse events (AE); incidence of grade 3 or higher AE; incidence of severe adverse events (SAE); incidence of AEs leading to discontinuation of drug use; incidence of AEs leading to suspension of drug use.

Full Information

First Posted
March 24, 2023
Last Updated
March 24, 2023
Sponsor
Hubei Cancer Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05801133
Brief Title
Pifenidone Prophylactic Therapy for Radiation Lung Injury in Patients Who Have Previously Received Immune Checkpoint Inhibitors
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2023 (Anticipated)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hubei Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pirfenidone combined with radiotherapy
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Pirfenidone
Other Intervention Name(s)
PFD, AiSiRui
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence rate of radiation pneumonia ≥ grade 2 (1 month, 3 month, 6 month)
Description
Incidence rate of radiation pneumonia ≥ grade 2 (1 month, 3 month, 6 month)
Time Frame
up to 6 month
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.
Time Frame
up to 6 month
Title
Disease Control Rate (DCR)
Description
DCR was defined as the percentage of participants who have a confirmed complete response(CR) or partial response(PR) or stable disease(SD) per RECIST 1.1 as assessed by investigator
Time Frame
up to 6 month
Title
6 month progression-free-survival (PFS) rate
Description
PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator
Time Frame
up to 6 month
Title
Treatment-related adverse events
Description
overall incidence of adverse events (AE); incidence of grade 3 or higher AE; incidence of severe adverse events (SAE); incidence of AEs leading to discontinuation of drug use; incidence of AEs leading to suspension of drug use.
Time Frame
up to 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; The investigator judged other situations not suitable for inclusion in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guang Han, MD,PhD
Phone
13886048178
Email
hg7913@hotmail.com
Facility Information:
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guang Han, MD.Phd
First Name & Middle Initial & Last Name & Degree
Guang Han, MD.Phd

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs