Real-World Outcomes of Resected EGFR-Mutated NSCLC Patients Treated With Adjuvant EGFR-TKI in China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 2,000
- 试验地点
- 14
- 主要终点
- To assess the effectiveness in real world of EGFR-TKI adjuvant therapy in resected NSCLC as measured by 5-year OS rate
研究概览
简要总结
This is a multi-centre, observational study, with retrospective data collection and prospective active follow-up. The aim is to measure the treatment pattern and real-world outcomes of EGFR-TKI as an adjuvant therapy in patients with early-stage EGFR-mutated NSCLC. The study period ranges from July 1st, 2022 to June 30th, 2031. Approximately 2,000 patients will be enrolled from 15 sites in China.
详细描述
This is a multi-centre, observational study, with retrospective data collection and prospective active follow-up. The study will enroll adult patients from China with resected, stage IB to III NSCLC who have received adjuvant EGFR-TKI therapy. Approximately 2,000 patients will be enrolled from 15 sites in China.
Patients will be followed up from the index date to the earliest of death, loss to follow-up, or the end of study. Data accumulated before informed consent will be collected retrospectively. For prospective data collection, every 12-week data collection frequency will be performed for the first 1-year from index date; and every 24-week data collection frequency will be performed afterward until the end of follow-up. All study-relevant data occurring during the follow-up period will be captured irrespective of planned follow-up frequency, with collection conducted via medical record abstraction and/or telephone interviews.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Diagnosed stage IB-III NSCLC on or prior to the index date;
- •Initiated adjuvant EGFR-TKI from July 1st, 2023 to June 30th, 2026
排除标准
- 未提供
结局指标
主要结局
To assess the effectiveness in real world of EGFR-TKI adjuvant therapy in resected NSCLC as measured by 5-year OS rate
时间窗: from enrollment up to 5 years after treatment initiation
OS is defined as the time from the first dose of EGFR-TKI adjuvant therapy until the date of death due to any cause. The analysis will include all patients received EGFR-TKI adjuvant therapy during the study. All deaths will be included, regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy. The primary measure of interest is the OS rate at 5 years
次要结局
- To assess the effectiveness in real world of EGFR-TKI adjuvant therapy in resected as measured by 2, 3, 4, 5-year DFS rate(from enrollment up to 5 years after treatment initiation)
- To assess the treatment duration and reason for discontinuation in real world of EGFR-TKI adjuvant therapy in resected NSCLC(from enrollment up to 5 years after treatment initiation)
- To assess the safety of EGFR-TKI used as an adjuvant， neoadjuvant therapy and used for post recurrence in resected NSCLC(from enrollment up to 5 years after treatment initiation)