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Status unknownNCT04632342Updated Nov 17, 2020

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

A Phase 2 interventional study of HL301 tablet 300mg and Placebo of HL301 tablet in Radiation Pneumonitis and Lung Cancer, sponsored by Hanlim Pharm. Co., Ltd.. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2020-11-17.

Sponsored by Hanlim Pharm. Co., Ltd. · Phase 2, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
87
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Radiation Pneumonitis
  • Lung Cancer
03

In context

Pneumonia

2,045 studies on the registry are indexed under Pneumonia; 284 are open to participants now.

This study's planned enrollment of 87 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Hanlim Pharm. Co., Ltd. is the lead sponsor of 49 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
87 participants (estimated)

Study arms

  • Experimental
    Experimental group 1

    HL301 1,200mg/day

    Drug: HL301 tablet 300mg

  • Experimental
    Experimental group 2

    HL301 1,800mg/day

    Drug: HL301 tablet 300mg

  • Placebo comparator
    Control group

    Placebo

    Drug: Placebo of HL301 tablet

Interventions

  • DrugHL301 tablet 300mg

    * Experimental group 1 : 2 tablets at once, twice a day * Experimental group 2 : 2 tablets at once, three times a day

  • DrugPlacebo of HL301 tablet

    2 tablets at once, three times a day

06

What researchers measure

Primary outcomes

  1. Percentage of subjects with radiation pneumonia of ≥ Grade 2

    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 outcomes

  1. The incidence of radiation pneumonia

    The incidence of radiation pneumonia

    Time frame: p to 24 weeks after completion of radiotherapy

  2. Percentage of subjects with radiation pneumonia of ≥ Grade 3

    Percentage of subjects with radiation pneumonia of ≥ Grade 3 evaluated by CTCAE v5.0

    Time frame: up to 24 weeks after completion of radiotherapy

  3. Severity at the first diagnosis of radiation pneumonia

    Severity at the first diagnosis of radiation pneumonia evaluated by CTCAE v5.0

    Time frame: up to 24 weeks after completion of radiotherapy

  4. Maximum severity of radiation pneumonia

    Maximum severity of radiation pneumonia evaluated by CTCAE v5.0

    Time frame: up to 24 weeks after completion of radiotherapy

  5. Changes in lung function

    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

  6. The incidence of pulmonary fibrosis

    The incidence of pulmonary fibrosis

    Time frame: at 24 weeks after completion of radiotherapy

  7. Lung fibrosis area

    Lung fibrosis area

    Time frame: at 24 weeks after completion of radiotherapy

  8. Lung volume reduction

    Lung volume reduction

    Time frame: at 24 weeks after completion of radiotherapy

  9. Pulmonary toxicity grade

    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

  10. The maximum grade of lung toxicity

    The maximum grade of lung toxicity evaluated by RTOG Acute radiation morbidity

    Time frame: up to 24 weeks after completion of radiotherapy

07

Study locations

1 site
  • Yonsei University Health System, Severance Hospital
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04632342
Lead sponsor
Hanlim Pharm. Co., Ltd.
Responsible party
Sponsor
First posted
Nov 17, 2020
Start date
Nov 2020 (estimated)
Primary completion
Jan 2022 (estimated)
Completion
Feb 2022 (estimated)
Last update
Nov 17, 2020

Study contacts

Jaeho Cho, M.D.
Contact
jjhmd@yuhs.ac
82-2-2228-8113

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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