KCT0003524尚未招募未知
Multi-center, Randomized, Double-blind, Placebo-controlled, Exploratory Study to Evaluate the Efficacy and Safety of HAD-B1 for Dose-finding in EGFR positive and locally advanced or metastatic NSCLC subjects who need Afatinib therapy
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Over 19-years-old;
- •2. Diagnosed with locally advanced or metastatic NSCLC who were unable to undergosurgery or radiation therapy;
- •3. Histologically or cytologically EGFR-positive, required afatinib therapy being failed or tolerated at least one cycle of erlotinib or gefitinib therapy;
- •4. With a lesion that can be measured by chest X-ray, CT or MRI with a single diameter or two diameters;
- •5. Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2;
- •6. Over six months life expectancy who have normal bone marrow function and solid organ function for more than 6 months;
- •- Bone marrow: ANC = 1.5x 109/L, platelet = 10x109/L, hemoglobin = 10g/dL
- •- Liver function: AST/ALT levels are below than 2 times of the normal upper limit
- •- Kidney function: creatinine levels are below than 2 times of the normal upper limit
- •7. Voluntarily sign a written informed consent in this trial.
排除标准
- •1. Experienced severe drug hypersensitivity to a particular drug or hard to administer oral drug;
- •2. Currently pregnant or breastfeeding(Fertile women need adequate contraception during the study period);
- •3. Metastasized to the central nervous system or considered to need concurrent therapy, such as primary site radiation therapy, chemotherapy, or immunotherapy;
- •4. T790M (threonine-to-methionine amino acid change at position 790) of the EGFR kinase domain(acquired, rebiopsy) mutation-positive;
- •5. Other serious disease;
- •(a) Uncontrollable congestive heart failure or unstable angina, myocardial infarction within 1 year of study participation, uncontrollable hypertension or high-risk arrhythmia
- •(b) unable to understand the research content due to neurological or psychiatric disorders such as dementia and seizures
- •(c) Uncontrollable infections such as tuberculosis and hepatitis
- •6. A history of diagnosis or treatment of malignant tumors other than non-small cell lung cancer;
- •7. Participated in the combined administration of other drug research except for afatinib and other clinical trials within 2 weeks;
- •8. Needed to change the cycles of chemotherapy or dosing regimens other than cisplatin or Needed to change the cycles of radiation doses during radiotherapy;
- •9. Needed administration of immuno-inhibitors or platinum-based chemotherapy after PD-L1 expression test with multiple metastases with symptoms;
- •10. Should take prohibited-medication during this clinical trial;
- •11. Be judged to be unsuitable for this clinical trial by researcher.
研究者
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