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

November 13, 2020 updated by: Hanlim Pharm. Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
87

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Jaeho Cho, M.D.
  • Phone Number: 82-2-2228-8113
  • Email: jjhmd@yuhs.ac

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Yonsei University Health System, Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Experimental group 1
HL301 1,200mg/day
Drug: HL301 tablet 300mg
  • Experimental group 1 : 2 tablets at once, twice a day
  • Experimental group 2 : 2 tablets at once, three times a day
EXPERIMENTAL: Experimental group 2
HL301 1,800mg/day
Drug: HL301 tablet 300mg
  • Experimental group 1 : 2 tablets at once, twice a day
  • Experimental group 2 : 2 tablets at once, three times a day
PLACEBO_COMPARATOR: Control group
Placebo
Drug: Placebo of HL301 tablet
2 tablets at once, three times a day

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of subjects with radiation pneumonia of ≥ Grade 2
Time Frame: up to 24 weeks after completion of radiotherapy
Percentage of subjects with radiation pneumonia of ≥ Grade 2 evaluated by CTCAE v5.0
up to 24 weeks after completion of radiotherapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The incidence of radiation pneumonia
Time Frame: p to 24 weeks after completion of radiotherapy
The incidence of radiation pneumonia
p to 24 weeks after completion of radiotherapy
Percentage of subjects with radiation pneumonia of ≥ Grade 3
Time Frame: up to 24 weeks after completion of radiotherapy
Percentage of subjects with radiation pneumonia of ≥ Grade 3 evaluated by CTCAE v5.0
up to 24 weeks after completion of radiotherapy
Severity at the first diagnosis of radiation pneumonia
Time Frame: up to 24 weeks after completion of radiotherapy
Severity at the first diagnosis of radiation pneumonia evaluated by CTCAE v5.0
up to 24 weeks after completion of radiotherapy
Maximum severity of radiation pneumonia
Time Frame: up to 24 weeks after completion of radiotherapy
Maximum severity of radiation pneumonia evaluated by CTCAE v5.0
up to 24 weeks after completion of radiotherapy
Changes in lung function
Time Frame: at 4 weeks and 12 weeks after completion of radiotherapy
Changes in lung function (FEV1, DL CO) at each time point after administration compared to before administration of investigational products
at 4 weeks and 12 weeks after completion of radiotherapy
The incidence of pulmonary fibrosis
Time Frame: at 24 weeks after completion of radiotherapy
The incidence of pulmonary fibrosis
at 24 weeks after completion of radiotherapy
Lung fibrosis area
Time Frame: at 24 weeks after completion of radiotherapy
Lung fibrosis area
at 24 weeks after completion of radiotherapy
Lung volume reduction
Time Frame: at 24 weeks after completion of radiotherapy
Lung volume reduction
at 24 weeks after completion of radiotherapy
Pulmonary toxicity grade
Time Frame: at the time of initial diagnosis of radiation pneumonia after completion of radiotherapy
Pulmonary toxicity grade evaluated by Radiation Therapy Oncology Group (RTOG) Acute radiation morbidity
at the time of initial diagnosis of radiation pneumonia after completion of radiotherapy
The maximum grade of lung toxicity
Time Frame: up to 24 weeks after completion of radiotherapy
The maximum grade of lung toxicity evaluated by RTOG Acute radiation morbidity
up to 24 weeks after completion of radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hanlim Pharm. Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HL_HL301_203

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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