First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy in Asia Area.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 106
- 试验地点
- 12
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
First real-world data on unresectable stage III NSCLC patients treated with durvalumab after chemoradiotherapy in Asia Area
详细描述
Study Design: The study is an observational review of medical records of patients diagnosed with unresectable stage III NSCLC in Taiwan, participating in an early access program (EAP). Physicians having treated patients in the EAP will be asked to recruit these patients to have their data abstracted from their medical records. Data will only be collected from routine clinical care.
Data Source(s): Centre staff will extract de-identified data from patient's medical charts. All collected data will be retrospective at time of extractions.
Study Population: Patients diagnosed with an unresectable stage III NSCLC, having not progressed after a CRT and who have received at least one dose of durvalumab following the CRT within the EAP will be the target population.
Exposure(s): Clinical characteristics, details of treatments (previous therapies, subsequent therapies), durvalumab exposure and serious AESIs Primary Outcome(s): PFS and OS. Sample Size Estimations: A target of 140 patients is estimated in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent or any locally required authorisation obtained from the patient prior to performing any protocol-related procedures
- •Adult of age ≥ 20 years at time of study entry
- •Patients must have been enrolled in one of the Pacific durvalumab EAPs
排除标准
- •Patients treated with durvalumab in clinical studies prior to the index date (first dose of durvalumab received within the EAP).
结局指标
主要结局
Progression free survival (PFS)
时间窗: time from initiation of the durvalumab therapy (index date) until earliest record of disease progression (estimate assessed up to 3 years)
Defined as the time from initiation of the durvalumab therapy (index date) until earliest record of disease progression (including metastatic disease) determined by physicians' assessment, metastatic recurrence or death (if no progression) or end of follow-up (for censored observations)
Overall survival (OS)
时间窗: time from durvalumab initiation date up to death or last date the patient was known to be alive (estimate assessed up to 5 years)
Defined as the time from durvalumab initiation date up to death or last date the patient was known to be alive (for censored observations).
次要结局
- Safety measures with retrospective collection of AESIs(time from initiation of durvalumab therapy until stop treatment (assessed up to 3 years))