A Retrospective Non-Interventional Study of PD-L1 Prevalence and Clinical Outcomes for Non-Small Cell Lung Cancer in Asia-Pacific
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 658
- 试验地点
- 1
- 主要终点
- Characterization of PD-L1 expression among NSCLC patients
研究概览
简要总结
MEDI-APEX is a non-interventional, retrospective, cohort study to characterize PD-L1 expression and to assess the clinical characteristics and outcomes among NSCLC patients
详细描述
MEDI-APEX is a non-interventional, retrospective, cohort study to characterize PD-L1 expression among NSCLC patients and to assess the clinical characteristics and outcomes of these patients with specific attention to EGFR, ALK, and KRAS mutations. The study will determine whether PD-L1 is a prognostic factor in the Asia-Pacific patient population; The study will enrol NSCLC patients with disease diagnosis between January 2010 and December 2014; The patients will be recruited from Asia-Pacific, potentially China, Japan, and South Korea. A total of approximately 750 patients will be enrolled in the study; around 250 NSCLC patients will be enrolled per country.
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
- •Adult male or female (according to age of majority as defined in local regulations).
- •NSCLC diagnosis between 01 January 2010 and 31 December
- •FFPET collected via core needle biopsy or resection and available in sufficient amount to complete PD-L1 testing.
- •FFPET tissue samples collected for NSCLC original diagnosis determination or for further analysis (e.g. research or treatment purposes) until the index date.
- •Patients with locally advanced or metastatic NSCLC who have initiated 1st line palliative chemotherapy by 31 December 2014.
排除标准
- •Patients with locally advanced NSCLC with resectable disease and treated with curative intent.
结局指标
主要结局
Characterization of PD-L1 expression among NSCLC patients
时间窗: from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction
Characterization of PD-L1 expression among locally advanced, unresectable NSCLC patients (Stage III) and newly diagnosed Stage IV or recurrent metastatic NSCLC patients.
次要结局
- Examination of overall survival by PD-L1 status among NSCLC patients(from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction)
- Examination of progression-free survival (PFS) by PD-L1 status among NSCLC patients(from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction)
- Description of patient characteristics by PD-L1 status among NSCLC patients.(from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction)
- Description of the overlap between PD-L1 expression and presence of EGFR, ALK or KRAS mutations among NSCLC patients(from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction)
- Examination of disease-free survival (DFS) by PD-L1 status among NSCLC patients(from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction)
- Examination of relapse-free survival (RFS) by PD-L1 status among NSCLC patients(from NSCLC diagnosis date between January 2010 and December 2014 until index date, defined as the date of data abstraction)