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Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of HL301 on Radiation Pneumonitis in Non-small Cell Lung Cancer Patients

Primary Purpose

Radiation Pneumonitis, Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HL301 tablet 300mg
Placebo of HL301 tablet
Sponsored by
Hanlim Pharm. Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Radiation Pneumonitis

Eligibility Criteria

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

Inclusion Criteria:

  • Male or Female, age ≥ 19 years
  • Stage III non-small cell lung cancer(NSCLC) patient who without surgical treatment

  • Patients scheduled for curative concurrent chemoradiotherapy

    • chemotherapy : paclitaxel and carboplatin
    • radiation therapy : IMRT, total 60~70Gy
  • Eastern Cooperative Oncology Group(ECOG) performance status of 0 to 2 at the screening visit
  • Subject whose remaining life expectancy is more than 6 months according to the judgment of investigator
  • Volunteer, be willing and able to provide written informed consent for the trial

Exclusion Criteria:

  • Subjects with pleural effusion
  • Subjects with a weight loss of 10% or more within the last 6 months from the screening visit
  • Subjects with a history of thoracic or neck radiotherapy or chemotherapy prior to screening visit
  • Subjects with distant metastases

  • Subjects with liver/renal dysfunction according to the following criteria on the screening test

    • Total Bilirubin >1.5 mg/dL
    • ALT or AST level is 2.0 times higher than the upper limit of normal (based on the institution)
    • Serum Creatinine >1.5 mg/dL
  • Subjects with serious cardiovascular disease within 3 months prior to the screening visit (ex. arrhythmia, congestive heart failure, infarction, unstable angina etc)
  • Subjects with serious systemic infection (≥ Grade 3, evaluated by CTCAE v5.0)
  • Patients with chronic or interstitial lung disease (excluding patients with chronic obstructive pulmonary disease (COPD)), patients with chronic bronchitis, patients with pneumonia
  • Subjects with thyroid dysfunction as present illness at the screening visit
  • Subjects who administered systemic steroids within 4 weeks prior to the date of randomization (except for cases when administered to prevent hypersensitivity reaction of paclitaxel)
  • Subjects who are hypersensitive to investigational products and standard anticancer treatments
  • Subjects who participate in other clinical trials within 30 days prior to the screening visit and administer investigational drugs or apply clinical trial medical devices
  • Women of childbearing age or men who do not agree to use a medically accepted method of contraception during the clinical trial
  • Pregnant or breast-feeding
  • Subjects who have clinical significance that is considered inappropriate for this clinical trial as judged by the investigator

Sites / Locations

  • Yonsei University Health System, Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Experimental group 1

Experimental group 2

Control group

Arm Description

HL301 1,200mg/day

HL301 1,800mg/day

Placebo

Outcomes

Primary Outcome Measures

Percentage of subjects with radiation pneumonia of ≥ Grade 2
Percentage of subjects with radiation pneumonia of ≥ Grade 2 evaluated by CTCAE v5.0

Secondary Outcome Measures

The incidence of radiation pneumonia
The incidence of radiation pneumonia
Percentage of subjects with radiation pneumonia of ≥ Grade 3
Percentage of subjects with radiation pneumonia of ≥ Grade 3 evaluated by CTCAE v5.0
Severity at the first diagnosis of radiation pneumonia
Severity at the first diagnosis of radiation pneumonia evaluated by CTCAE v5.0
Maximum severity of radiation pneumonia
Maximum severity of radiation pneumonia evaluated by CTCAE v5.0
Changes in lung function
Changes in lung function (FEV1, DL CO) at each time point after administration compared to before administration of investigational products
The incidence of pulmonary fibrosis
The incidence of pulmonary fibrosis
Lung fibrosis area
Lung fibrosis area
Lung volume reduction
Lung volume reduction
Pulmonary toxicity grade
Pulmonary toxicity grade evaluated by Radiation Therapy Oncology Group (RTOG) Acute radiation morbidity
The maximum grade of lung toxicity
The maximum grade of lung toxicity evaluated by RTOG Acute radiation morbidity

Full Information

First Posted
November 13, 2020
Last Updated
November 13, 2020
Sponsor
Hanlim Pharm. Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04632342
Brief Title
Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of HL301 on Radiation Pneumonitis in Non-small Cell Lung Cancer Patients
Official Title
A Multicenter, Randomized, Double-blinded, Placebo-controlled, Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Placebo on Radiation Pneumonitis in Unresectable Non-small Cell Lung Cancer Patients Treated With Curative Concurrent Chemoradiotherapy Using Paclitaxel and Carboplatin
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 2020 (Anticipated)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
February 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanlim Pharm. Co., Ltd.

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
The purpose of this clinical trial is to evaluate the safety when HL301 is administered to unresectable non-small cell lung cancer patients who receive chemoradiotherapy with Paclitaxel and Carboplatin and to search for a clinically appropriate dose by evaluating the efficacy by comparing the radiation pneumonia incidence rate with the control group.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
87 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group 1
Arm Type
Experimental
Arm Description
HL301 1,200mg/day
Arm Title
Experimental group 2
Arm Type
Experimental
Arm Description
HL301 1,800mg/day
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
HL301 tablet 300mg
Intervention Description
Experimental group 1 : 2 tablets at once, twice a day Experimental group 2 : 2 tablets at once, three times a day
Intervention Type
Drug
Intervention Name(s)
Placebo of HL301 tablet
Intervention Description
2 tablets at once, three times a day
Primary Outcome Measure Information:
Title
Percentage of subjects with radiation pneumonia of ≥ Grade 2
Description
Percentage of subjects with radiation pneumonia of ≥ Grade 2 evaluated by CTCAE v5.0
Time Frame
up to 24 weeks after completion of radiotherapy
Secondary Outcome Measure Information:
Title
The incidence of radiation pneumonia
Description
The incidence of radiation pneumonia
Time Frame
p to 24 weeks after completion of radiotherapy
Title
Percentage of subjects with radiation pneumonia of ≥ Grade 3
Description
Percentage of subjects with radiation pneumonia of ≥ Grade 3 evaluated by CTCAE v5.0
Time Frame
up to 24 weeks after completion of radiotherapy
Title
Severity at the first diagnosis of radiation pneumonia
Description
Severity at the first diagnosis of radiation pneumonia evaluated by CTCAE v5.0
Time Frame
up to 24 weeks after completion of radiotherapy
Title
Maximum severity of radiation pneumonia
Description
Maximum severity of radiation pneumonia evaluated by CTCAE v5.0
Time Frame
up to 24 weeks after completion of radiotherapy
Title
Changes in lung function
Description
Changes in lung function (FEV1, DL CO) at each time point after administration compared to before administration of investigational products
Time Frame
at 4 weeks and 12 weeks after completion of radiotherapy
Title
The incidence of pulmonary fibrosis
Description
The incidence of pulmonary fibrosis
Time Frame
at 24 weeks after completion of radiotherapy
Title
Lung fibrosis area
Description
Lung fibrosis area
Time Frame
at 24 weeks after completion of radiotherapy
Title
Lung volume reduction
Description
Lung volume reduction
Time Frame
at 24 weeks after completion of radiotherapy
Title
Pulmonary toxicity grade
Description
Pulmonary toxicity grade evaluated by Radiation Therapy Oncology Group (RTOG) Acute radiation morbidity
Time Frame
at the time of initial diagnosis of radiation pneumonia after completion of radiotherapy
Title
The maximum grade of lung toxicity
Description
The maximum grade of lung toxicity evaluated by RTOG Acute radiation morbidity
Time Frame
up to 24 weeks after completion of radiotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or Female, age ≥ 19 years Stage III non-small cell lung cancer(NSCLC) patient who without surgical treatment Patients scheduled for curative concurrent chemoradiotherapy chemotherapy : paclitaxel and carboplatin radiation therapy : IMRT, total 60~70Gy Eastern Cooperative Oncology Group(ECOG) performance status of 0 to 2 at the screening visit Subject whose remaining life expectancy is more than 6 months according to the judgment of investigator Volunteer, be willing and able to provide written informed consent for the trial Exclusion Criteria: Subjects with pleural effusion Subjects with a weight loss of 10% or more within the last 6 months from the screening visit Subjects with a history of thoracic or neck radiotherapy or chemotherapy prior to screening visit Subjects with distant metastases Subjects with liver/renal dysfunction according to the following criteria on the screening test Total Bilirubin >1.5 mg/dL ALT or AST level is 2.0 times higher than the upper limit of normal (based on the institution) Serum Creatinine >1.5 mg/dL Subjects with serious cardiovascular disease within 3 months prior to the screening visit (ex. arrhythmia, congestive heart failure, infarction, unstable angina etc) Subjects with serious systemic infection (≥ Grade 3, evaluated by CTCAE v5.0) Patients with chronic or interstitial lung disease (excluding patients with chronic obstructive pulmonary disease (COPD)), patients with chronic bronchitis, patients with pneumonia Subjects with thyroid dysfunction as present illness at the screening visit Subjects who administered systemic steroids within 4 weeks prior to the date of randomization (except for cases when administered to prevent hypersensitivity reaction of paclitaxel) Subjects who are hypersensitive to investigational products and standard anticancer treatments Subjects who participate in other clinical trials within 30 days prior to the screening visit and administer investigational drugs or apply clinical trial medical devices Women of childbearing age or men who do not agree to use a medically accepted method of contraception during the clinical trial Pregnant or breast-feeding Subjects who have clinical significance that is considered inappropriate for this clinical trial as judged by the investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaeho Cho, M.D.
Phone
82-2-2228-8113
Email
jjhmd@yuhs.ac
Facility Information:
Facility Name
Yonsei University Health System, Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaeho Cho
Phone
82-2-2228-8113
Email
jjhmd@yuhs.ac

12. IPD Sharing Statement

Learn more about this trial

Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of HL301 on Radiation Pneumonitis in Non-small Cell Lung Cancer Patients

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