An Observational, Non-interventional, Multi-center, Chart Review Study Conducted Among Patients Enrolled in an AZD9291 Early Access Program in Hong Kong, With Locally Advanced/Metastatic EGFR T790M Mutation-positive NSCLC and Prior Exposure to EGFR TKI Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 156
- 试验地点
- 4
- 主要终点
- Association between T790M mutant status and overal survival
研究概览
简要总结
To assess the efficacy of single-agent osimertinib in relation to EGFR T790M mutant allele fraction (AF) in a real-world setting.
详细描述
This study will assess the efficacy and safety of single-agent osimertinib in patients with locally advanced or metastatic EGFR T790M-positive NSCLC within the context of the early access program in Hong Kong. In particular, osimertinib treatment efficacy will be assessed in the context of the relationship between EGFR T790M mutant AF and survival outcomes, particularly overall survival. In a real-world setting, analysis of overall survival benefit is considered less sensitive to differences in healthcare systems and standards. Other clinical outcomes including response rate (based on physician's judgement) and time to treatment discontinuation (TTD) will be examined. This study will also describe current practice for molecular testing and EGFR mutation profiles in this patient population.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients enrolled in AZD9291 Named Patient Program in Hong Kong
- •Patients with confirmed advanced (locally advanced (stage IIIB) or metastatic (stage IV)) NSCLC with a positive test result for the EGFR T790M mutation
- •Patients who have previously received EGFR TKI therapy or discontinued an EGFR TKI at the time of enrolment in the study
- •Provision of written informed consent (for patients alive at the time of study enrolment)
- •Documented patients with trackable medical records
排除标准
- •Enrolment in studies that prohibit any participation in this non-interventional study
研究组 & 干预措施
EGFR T790M positive NSCLC patients
Patients with locally advanced/metastatic EGFR T790M positive NSCLC progressed on previous EGFR TKI treatment.
干预措施: Osimertinib (Drug)
结局指标
主要结局
Association between T790M mutant status and overal survival
时间窗: Followed up to 2 years after last patient in
To assess the association of EGFR T790M mutant allele fraction (AF) level with the overall survival (OS) of subjects with advanced/metastatic EGFR T790M-positive NSCLC treated with osimertinib
次要结局
- T790M mutation testing sample(Within 14 days after enrollment date)
- Overal survival (OS)(Followed up to 2 years after last patient in)
- Treatment pattern(Followed up to 2 years after last patient in)
- T790M mutation testing platform(Within 14 days after enrollment date)
- RR(Follow up within 6 months after last patient in)
- TTD(Followed up to 12 months after last patient in)
- Adverse event of special interest(Followed up to 12 months after last patient in)
- EGFR testing mutation subtype(Within 14 days after enrollment date)