NCT03133234已完成不适用
An Observational, Retrospective, Real World Study of Osimertinib in Ethnic Chinese Patients With Locally Advanced/Metastatic T790M Mutation-Positive Non-small-cell Lung Cancer (NSCLC )Progressed on Previous Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI).
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
- AstraZeneca
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
To assess the effectiveness and safety of osimertinib treatment in a real world setting.
详细描述
The current study will not only assess the effectiveness of osimertinib treatment in a real world setting, but will also help us to understand the real-world testing patterns among T790M mutation positive locally advanced or metastatic NSCLC patients who have progressed after EGFR TKI treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Above 18 years of age;
- •Locally advanced (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy
- •Confirmed T790M mutation
- •Progressed on previous EGFR TKI treatment. Patients may have also received additional lines of treatment
- •Received osimertinib treatment in the participating site between May 1st and Oct 31st 2016
排除标准
- •Enrolment in studies that prohibit any participation in this observational study
研究组 & 干预措施
EGFR T790M Patients
Patients with locally advanced/metastatic EGFR T790M positive NSCLC progressed on previous EGFR TKI
干预措施: osimertinib (Drug)
结局指标
主要结局
ORR
时间窗: Followed up with 6 months after last patient in
Overall response rate (ORR), defined as the proportion of patients with a best response of "responding" to treatment by investigator assessment
次要结局
- PFS(Followed up 10 months after last subject in)
- T790M mutation testing time(Within 14 days after enrollment date)
- Treatment patterns(Followed up 10 months after last patient in)
- Adverse events(Follow up 10 months after last patient in.)
- Adverse event intensity(Follow up 10 months after last patient in.)
- T790M mutation testing sample(Within 14 days after enrollment date)
- T790M mutation testing platform(Within 14 days after enrollment date)
- EGFR testing mutation subtype(Within 14 days after enrollment date)
研究者
研究点 (1)
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