NCT02960607Unknown2 期
A Phase II Study of High-dose Icotinib in Previously Treated Non-small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor Mutation
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Progression Free survival
研究概览
简要总结
The purpose of this study is to investigate whether high-dose icotinib treatment beyond disease progression is beneficial for NSCLC patients who have EGFR mutation and who have responded to EGFR TKI.
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
- •Histologically confirmed stage IIIB/IV NSCLC
- •Investigator confirmed progression according RECIST 1.1 during previous icotinib treatment
- •Patients whose tumors:
- •are EGFR mutation-positive or
- •T790M mutation-negative
- •Performance status: WHO 0-2
- •Measurable disease according to RECIST 1.1
- •at least one measureable lesion .if only one measureable lesion, the biological nature must be confirmed by cytology or histology
- •a single diameter of lesion could be measured by at least one of the following methods: Chest or abdominal computed tomography(CT)or magnetic resonance imaging(MRI),conventional methods of diameter at least 20mm diameter spiral CT OR at least 10mm
- •ANC ≥ 1.5*109/L, Platelets ≥ 75*109/L, Hgb≥ 9g/dL, Alanine amino transferase ≤ 2 × Upper limit of normal (ULN), Alkaline phosphatase ≤ 2.5 × ULN (< 5 × ULN if liver metastases), Serum Creatinine ≤ 1.5 × ULN
- •Women of childbearing age must have a pregnancy test 7 days before treatment and the result were negative ,men of childbearing age: surgical sterilization or treatment during and after the end of three months to take contraceptive measures
- •Patient must be able to comply with the protocol
排除标准
- •Patient with symptomatic central nervous system metastases
- •Patient has known active hepatitis B or C, or HIV infection
- •Pregnant or breastfeeding.
- •Patient with uncontrolled undercurrent illness or circumstances that could limit compliance with the study
研究组 & 干预措施
Icotinib
Experimental
250mg, tid until disease progression or unacceptable toxicities occurred
干预措施: Icotinib (Drug)
结局指标
主要结局
Progression Free survival
时间窗: 2 years
次要结局
未报告次要终点
研究者
Yutao Liu
Associate Chief Physician
Chinese Academy of Medical Sciences
研究点 (1)
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