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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
87
* Experimental group 1 : 2 tablets at once, twice a day * Experimental group 2 : 2 tablets at once, three times a day
2 tablets at once, three times a day
Yonsei University Health System, Severance Hospital
Seoul, South Korea
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
The incidence of radiation pneumonia
The incidence of radiation pneumonia
Time frame: p to 24 weeks after completion of radiotherapy
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
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
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
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
The incidence of pulmonary fibrosis
The incidence of pulmonary fibrosis
Time frame: at 24 weeks after completion of radiotherapy
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Lung fibrosis area
Lung fibrosis area
Time frame: at 24 weeks after completion of radiotherapy
Lung volume reduction
Lung volume reduction
Time frame: at 24 weeks after completion of radiotherapy
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
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