Randomized Phase II Study of Gefitinib Plus Nimotuzumab Versus Gefitinib in Patients With Advanced Non-small Cell Lung Cancer: Dual-agent Molecular Targeting of EGFR (DATE)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Progression free survival rate at 3 months
研究概览
简要总结
Combining nimotuzumab to gefitinib may not only potentiate cellular cytotoxicity, but may also assist in overcoming inherent or acquired resistance to gefitinib alone.
详细描述
Reversible EGFR tyrosine kinase inhibitors (TKI), such as gefitinib, were shown to be effective in patients with non-small cell lung cancer (NSCLC). However, patients almost invariably develop resistance to TKIs and have disease progression. Nimotuzumab is a humanized monoclonal antibody targeting the EGFR.
Combining nimotuzumab to gefitinib may not only potentiate cellular cytotoxicity, but may also assist in overcoming inherent or acquired resistance to gefitinib alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of written informed consent prior to any study specific procedures
- •Unresectable non-small cell lung cancer
- •ECOG performance status of 0 to 2
- •Male or female; ≥ 20 years of age
- •Subjects whose disease has progressed after platinum-based chemotherapy
- •Subjects with measurable lesion
排除标准
- •Inadequate organ functions
- •Disease progression after 2 or more previous chemotherapy regimens
- •Prior therapy with EGFR-tyrosine kinase inhibitor or Anti-EGFR Monoclonal Ab
- •Any clinically significant gastrointestinal abnormalities
- •Past medical history of interstitial lung disease
- •Pregnant or lactating female
研究组 & 干预措施
Gefitinib plus Nimotuzumab
Combination therapy group: Gefitinib(250mg daily) and Nimotuzumab (200mg weekly)
干预措施: Gefitinib and Nimotuzumab (Drug)
Gefitinib alone
Mono-therapy group: Gefitinib(250mg daily)
干预措施: Gefitinib (Drug)
结局指标
主要结局
Progression free survival rate at 3 months
时间窗: 3 months after randomization of last patient
The progression-free survival rate at 3 months of the patients with no progression of disease or death due to any cause until 3 months is elapsed after being randomized.
次要结局
- Progression free survival (PFS)(3 months after randomization of last patient)
- Overall safety profile(3 months after randomization of last patient)
- Overall survival (OS)(3 months after randomization of last patient)
- Objective response rate (ORR)(3 months after randomization of last patient)