A Single Center, Open Label, Dose-Finding Study to Determine the Safety of Icotinib in Combination With Whole Brain Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of Icotinib at different dose levels in combination with whole brain radiotherapy for NSCLC patients with brain metastases and EGFR mutation.
详细描述
The long-term control of brain metastases becomes a clinical challenge. Whole brain radiotherapy, the standard treatment for patients with multiple brain metastases, can only bring a modest survival improvement around 3-6 months. EGFR-TKIs like icotinib with its proven activity in non-small cell lung cancer may provide clinical benefits in such patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histological or cytological confirmation of non-small cell lung cancer (NSCLC).
- •Diagnosis of brain metastases on a Gadolinium-enhanced MRI. More than 3 sites of intracranial metastases, or the longest diameter of the intracranial lesion is more than 3cm.
- •Positive EGFR mutation.
排除标准
- •Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
- •CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.
研究组 & 干预措施
Icotinib+WBRT
Standard whole brain radiotherapy plus icotinib, which is designed to administered at 5 dose according to "3+3" until disease progression or intolerable toxicity.
干预措施: icotinib (Drug)
Icotinib+WBRT
Standard whole brain radiotherapy plus icotinib, which is designed to administered at 5 dose according to "3+3" until disease progression or intolerable toxicity.
干预措施: Whole brain radiotherapy (Radiation)
结局指标
主要结局
Safety and tolerability
时间窗: 6-12 months
All cause adverse events (AEs) and serious adverse events (SAEs)
次要结局
- Quality of life measured by FACT-L/LCS 4.0(1 year)
- Neurological progression-free survival(3-6 month)
- Progression-free survival(3-6 months)
- Overall survival(6-12 months)
- Response rate(3-6 month)
- Neurocognitive effects(3-6 months)