Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of HL301 on Radiation Pneumonitis in Non-small Cell Lung Cancer Patients
NCT ID: NCT04632342
Last Updated: 2020-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
87 participants
INTERVENTIONAL
2020-11-30
2022-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Experimental group 1
HL301 1,200mg/day
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 group 2
HL301 1,800mg/day
HL301 tablet 300mg
* Experimental group 1 : 2 tablets at once, twice a day
* Experimental group 2 : 2 tablets at once, three times a day
Control group
Placebo
Placebo of HL301 tablet
2 tablets at once, three times a day
Interventions
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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 of HL301 tablet
2 tablets at once, three times a day
Eligibility Criteria
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Inclusion Criteria
* 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 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
19 Years
ALL
No
Sponsors
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Hanlim Pharm. Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Yonsei University Health System, Severance Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Jaeho Cho
Role: primary
Other Identifiers
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HL_HL301_203
Identifier Type: -
Identifier Source: org_study_id