NCT01487174终止3 期
A Multi-Center, Phase 3, Double-Blind, Randomized, and Controlled Trial of KD019 vs Erlotinib in Subjects With Stage IIIB/IV Non-Small Cell Lung Cancer Who Have Progressed After First- or Second-Line Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
This study involves treatment with KD019 or erlotinib in patients with Non-small cell lung cancer (NSCLC) who have progressed after first- or second- line chemotherapy. It is hypothesized that KD019 can prolong survival compared with erlotinib.
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
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
KD019
Experimental
KD019 will be administered orally once daily at a dose of 300 mg. One dose reduction to 200 mg will be permitted.
干预措施: KD019 (Drug)
Erlotinib
Active Comparator
Erlotinib will be administered orally once daily at a dose of 150 mg. One dose reduction to 100 mg daily will be permitted.
干预措施: Erlotinib (Drug)
结局指标
主要结局
Overall survival
时间窗: Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year
次要结局
- Progression-free survival(Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year)
- Number and type of adverse events related to KD019(Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year)
- Objective response rate(Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year)
研究者
研究点 (2)
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