NCT01850147Unknown2 期
Study of Efficacy and Safety of Sequential Low-dose Sunitinib With Chemotherapy in Advanced Non-small Cell Lung Cancer After Failure of Conventional Regimen
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 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 determine whether sequential application of low-dose short-term sunitinib and chemotherapy is effective in the treatment of non-small cell lung cancer after failure of conventional therapy. Safety of this regimen will also be evaluated.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic or cytologic diagnosis of stage IIIB/IV NSCLC
- •ECOG PS: 0,1
- •Unidimensional or bi-dimensional measurable disease
- •Receive prior treatment including first-line platinum-based chemotherapy, standard second-line chemotherapy and 1 EGF/EGFR inhibitor
- •Evidence of disease progression
- •Life expectancy >12 weeks
- •Neutrophils > 1.5 109/l, Platelets > 100 109/l, Hemoglobin > 9g/dl, Total bilirubin < 1.5 UNL, AST (SGOT) and ALT (SGPT) < 2.5 UNL, Alkaline phosphatases < 5 UNL, Creatinine < 1 UNL
排除标准
- •Pre-existing hemoptysis of a severity > grade 3 by NCI CTCAE criteria within 4 weeks prior to study entry
- •Uncontrolled hypertension
- •CHF, angina or arrhythmias
- •LVEF < 1 UNL
- •Existing a second malignancy within 5 years
- •Infected with HIV
研究组 & 干预措施
Sunitinib
Experimental
干预措施: Sunitinib, chemotherapy (Drug)
结局指标
主要结局
progression-free survival
时间窗: up to 2 years
The primary objective of this study is to evaluate the median progression-free survival of this sequential regimen.
次要结局
- overall survival(up to 2 years)
- disease control rate(up to 6 months)
- Safety(up to 2 years)
研究者
LI Junling
Professor and Chief physician
Chinese Academy of Medical Sciences
研究点 (1)
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