A Study of Endostar Combination With Chemotherapy and Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors in Lung Cancer Rechallenging Treatment After Resistance of EGFR-TKI and Tumor Progression
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Objective Responese Rate
研究概览
简要总结
Here we are going to find a method by using available multiple drugs including angiogenesis medicine - Endostar to treat lung cancer patients who acquired resistence from EGFR-TKI but have responsed to it before.
详细描述
Lung cancer patients who received epidermal growth factor receptor tyrosine kinase inhibitors(EGFR-TKI) will acquiring resistance to the drug. This is a study of using Endostar, an angiogentic medicine, combination with chemotherapy and EGFR-TKI in lung cancer rechallenging treatment after resistance of EGFR-TKI and progression disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pathologic confirmation of NSCLC with tissue diagnosis or cytologic diagnosis, whose NSCLCs are locally advanced or metastatic Stage III-B / IV adenocarcinoma, and are inoperable and incurable with radiotherapy.
- •Life expectancy of at least three (3) months after the start of administration of the investigational drug.
- •Eastern Cooperative Oncology Group (ECOG) performance Score 0 to
- •Patients with at least one tumor lesion that can accurately be measured by CT or MRI in at least one dimension with longest diameter to be recorded as no less than double the slice thickness and >=10 mm.
- •Patient received at least 6 months EGFR-TKI and show tumor progress
- •Adequate hematologic hepatic and renal functions based on the normal conditions of chemotherapy
- •Patient signed consent form and adherence and geographic location are liable to follow up
排除标准
- •CNS metastasis
- •Active infection
- •Bleeding tendency or blood coagulation dysfunction
- •History of neurological or psychiatric disorders, including epilepsy, or dementia
- •Pregnancy or breast-feeding women
- •Organ transplant long-term use of immunosuppressive drugs
- •Arrhythmia need anti-arrhythmic treatment or other risk of heart disease
- •Use other targeted drugs during the research
- •Other conditions may not allowed to join in this study according to the researcher's judgment
研究组 & 干预措施
Endostar Arm
Gefitinib re-challenging, oral daily use Docetaxel 60mg/m2 and Cisplatin 70mg/m2, 21 days Recombinant human endostatin 15mg/day, day 1 - 14
干预措施: Recombinant human endostatin (Drug)
Standard Arm
Gefitinib re-challenging, oral daily use Docetaxel 60mg/m2 and Cisplatin 70mg/m2, 21 days Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Objective Responese Rate
时间窗: in two months
次要结局
- Progression Free Survival(up to six months)
- Overall Survial(follow up every two months, about two years)
- Number of Serious Adverse Events(within two months)
研究者
Li Liang
Associate chief physician
Peking University Third Hospital