NCT04632342Unknown2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Percentage of subjects with radiation pneumonia of ≥ Grade 2
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Experimental group 1
Experimental
HL301 1,200mg/day
干预措施: HL301 tablet 300mg (Drug)
Experimental group 2
Experimental
HL301 1,800mg/day
干预措施: HL301 tablet 300mg (Drug)
Control group
Placebo Comparator
Placebo
干预措施: Placebo of HL301 tablet (Drug)
结局指标
主要结局
Percentage of subjects with radiation pneumonia of ≥ Grade 2
时间窗: up to 24 weeks after completion of radiotherapy
Percentage of subjects with radiation pneumonia of ≥ Grade 2 evaluated by CTCAE v5.0
次要结局
- The incidence of radiation pneumonia(p to 24 weeks after completion of radiotherapy)
- Severity at the first diagnosis of radiation pneumonia(up to 24 weeks after completion of radiotherapy)
- Lung volume reduction(at 24 weeks after completion of radiotherapy)
- Percentage of subjects with radiation pneumonia of ≥ Grade 3(up to 24 weeks after completion of radiotherapy)
- Maximum severity of radiation pneumonia(up to 24 weeks after completion of radiotherapy)
- Changes in lung function(at 4 weeks and 12 weeks after completion of radiotherapy)
- Lung fibrosis area(at 24 weeks after completion of radiotherapy)
- The incidence of pulmonary fibrosis(at 24 weeks after completion of radiotherapy)
- Pulmonary toxicity grade(at the time of initial diagnosis of radiation pneumonia after completion of radiotherapy)
- The maximum grade of lung toxicity(up to 24 weeks after completion of radiotherapy)
研究者
研究点 (1)
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