NCT03375242已完成不适用
XALKORI ROS1+NSCLC DRUG USE INVESTIGATION
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- The incidence of adverse drug reactions in this surveillance.
研究概览
简要总结
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •patients with unresectable progressive/recurrent NSCLC who are naive to XALKORI and whose tumor is ROS1 gene positive
排除标准
- •Patients with past history of hypersensitivity to any of the ingredients of XALKORI
研究组 & 干预措施
crizotinib
干预措施: crizotinib (Drug)
结局指标
主要结局
The incidence of adverse drug reactions in this surveillance.
时间窗: 52 weeks
次要结局
- Objective Response Rate (ORR)(12, 24, 52 weeks)
研究者
研究点 (2)
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