CODAK: A Retrospective Observational Research Study to Describe the Characteristics and Real-world Clinical Outcomes of Patients With Locally Advanced, Unresectable Stage III Non-small Cell Lung Cancer Receiving Durvalumab in the UK.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 115
- 试验地点
- 10
- 主要终点
- Overall Survival
研究概览
简要总结
This is a retrospective observational research study to describe the characteristics and real-world clinical outcomes of patients with locally advanced, unresectable Stage III non-small cell lung cancer receiving durvalumab in the United Kingdom (the CODAK study). Physicians who have treated patients who have locally advanced, unresectable Stage III NSCLC with durvalumab will be requested to recruit patients to have their clinical data abstracted from their clinical records in line with local laws. Data from this study will provide UK-specific real-world data on patients receiving durvalumab through the Early Access Programme (EAP) or post-reimbursement.
详细描述
Primary Objectives
The primary study objectives, in patients with locally advanced, unresectable Stage III NSCLC treated with durvalumab as part of the UK EAP or non-EAP, are:
-
To describe clinical outcomes
-
To describe the patient demographic and clinical characteristics Secondary Objective
-
To describe treatment patterns of durvalumab
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
- •Patient has documented diagnosis of locally advanced, unresectable Stage III NSCLC
- •Patient has received platinum-based CRT and received ≥1 dose of durvalumab
- •Patient was initiated on durvalumab (index event) between 1st September 2017 and 31st December 2019 via the EAP or non-EAP
- •Patient was aged ≥18 years at durvalumab initiation
排除标准
- •Patients who participated in the PACIFIC-R study
- •Participation in any clinical study with an investigational product at the time of durvalumab initiation or during the observational period
结局指标
主要结局
Overall Survival
时间窗: 24 months
This study will estimate the proportion of patients known to be alive at 24 months post-index event
次要结局
- Time to first subsequent therapy(Up to 24 months)
- Time to Treatment Discontinuation(Up to 24 months)
- Progression Free Survival(24 months)
- Second Progression Free Survival(24 months)
- Best Overall Response(Up to 24 months)