REtrospective, obserVational Study to Describe the Treatment Patterns and Outcomes of Epidermal Growth Factor Receptor Mutant (EGFRm) Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) Patients in Belgium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- demographic characteristics of patients diagnosed between 1 September 2015 and 31 December 2017
研究概览
简要总结
This is a retrospective, observational, multicentre study to evaluate treatment patterns and outcomes of patients diagnosed with locally advanced or metastatic EGFRm NSCLC in Belgium
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
- •Male or female, aged at least 18 years
- •Pathologically confirmed NSCLC
- •Tumour harbours a mutation of EGFR
- •Diagnosis (radiologically or pathologically confirmed) of locally advanced or metastatic NSCLC, not amenable to curative surgery or chemoradiotherapy between 01 September 2015 and 31 December 2017
排除标准
- •No follow-up data available after diagnosis of locally advanced or metastatic EGFRm NSCLC
- •Patients who objected to participation to the study
研究组 & 干预措施
Patients with EGFR mutation positive NSCLC
干预措施: 1L treatment (Drug)
Patients with EGFR mutation positive NSCLC
干预措施: 2L Treatment (Drug)
Patients with EGFR mutation positive NSCLC
干预措施: 3L treatment (Drug)
结局指标
主要结局
demographic characteristics of patients diagnosed between 1 September 2015 and 31 December 2017
时间窗: 28 months
NSCLC disease characteristics at start of 2L or 3L treatment during observation window
时间窗: 36 months
observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Descriptive statitistics will be used to analyse these endpoints.
EGFR testing characteristics at diagnosis between 1 september 2015 and 31 December 2017
时间窗: 28 months
NSCLC characteristics at diagnosis between 1 september 2015 and 31 December 2017
时间窗: 28 months
Type of treatment received during 1L, 2L or 3L treatment during the observation window
时间窗: 36 months
observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Descriptive statitistics will be used to analyse these endpoints.
Time on treatment during 1L, 2L or 3L treatment during the observation window
时间窗: 36 months
observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Descriptive statitistics will be used to analyse these endpoints.
Proportion of patients receiving a definitive, systemic therapy for NSCLC or no definitive, systemic therapy for NSCLC/best supportive care treatment after progression on their previous therapy
时间窗: 36 months
observation window: between date of diagnosis until the data cut-off , 01 September 2018, end of clinical activity or death, whichever comes first. Descriptive statitistics will be used to analyse these endpoints.
Reason for discontinuation after 1L, 2L or 3L treatment during observation window
时间窗: 36 months
observation window: between date of diagnosis until the data cut-off, 1 september 2018, end of clinical activity or death, whichever comes first. Descriptive statistics will be used to analyse these endpoints.
EGFR testing characteristics after progression on previous treatment
时间窗: 36 months
observation window: between date of diagnosis until the data cut-off, 01 September 2018 until end of clinical activity or death, whichever comes first. Descriptive statistics will be used to analyse these endpoints.
次要结局
- PFS for 1L, 2L or 3L treatment during the observation window(36 months)
- Time to start of subsequent treatment after 1L and 2L treatment during the observation window(36 months)
- OS during observation window(36 months)
- Time-to-treatment discontinuation for 1L, 2L and 3L treatment during the observation window(36 months)