A Pan-Asian Clinical Database of EGFR Exon 20 Insertion Mutated Non-small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 3
- 主要终点
- Overall survival (OS)
研究概览
简要总结
There are limited in depth studies on the epidemiology and clinical management of EGFR exon 20 insertion mutated NSCLC in Asia. In addition, there is preliminary data suggesting the exact location of the insertion and variant may influence the response and efficacy to novel EGFR targeted therapies.
This study aims to fill this knowledge gap, by comprehensively characterising the epidemiology and clinical outcomes of Asian advanced EGFR exon 20 insertion mutated NSCLC patients.
详细描述
This study will be a multi-center observational study and will enroll patients with advanced EGFR exon 20 insertion mutated NSCLC.
The study will include patients recruited from countries across Asia, including sites in, but not limited to - Hong Kong, Korea, Singapore, Taiwan and Thailand. There will be approximately 20-30 sites recruiting for the study. In Singapore, sites may include National Cancer Centre Singapore (NCCS), National University Hospital (NUH) and Tan Tock Seng Hospital (TTSH).
Approximately 600 patients will be enrolled retrospectively.
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
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed advanced NSCLC
- •Positive testing result from any locally approved test (including but not limited to RT-PCR, Cobas and NGS) for EGFR exon 20 insertion mutation
- •Diagnosis date from 1 Jan 2013 to 31 Dec 2024 (to allow for minimum 12 months of follow-up clinical and treatment outcome data)
- •Male or female adults, age as defined by local regulations
排除标准
- •Patients without an EGFR exon 20 insertion mutation
结局指标
主要结局
Overall survival (OS)
时间窗: Up to 10 years.
Time from diagnosis to death.
Duration of therapy (DOT)
时间窗: Up to 10 years.
Time from start of treatment regimen to end of treatment regimen.
Real-world progression-free survival (PFS)
时间窗: Up to 10 years.
Time from start of treatment regimen to disease progression or death.
次要结局
未报告次要终点