Real-world Study on Sequential Therapy With Dacomitinib as First-line Treatment Followed by 3rd Generation EGFR-TKI in Patients With EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- time to treatment failure
研究概览
简要总结
This is a non-interventional, multi-center, ambispective cohort study in real world to describe the effectiveness and safety profile in patients with EGFR mutation-positive advanced NSCLC treated with dacomitinib (Vizimpro®) as the first-line treatment followed by 3rd generation EGFR-TKI in case the T790M resistance mutation was developed.
详细描述
This is a multi-center observational study with both retrospective and prospective data collections to describe the effectiveness and safety of sequential dacomitinib and 3rd generation EGFR-TKI used in patients with EGFR mutation-positive NSCLC with T790M-aquired resistance in a clinical practice setting. The study will include patients who were or will be diagnosed as advanced NSCLC with EGFR mutation positive and received dacomitinib as first-line treatment followed by second-line 3rd generation EGFR-TKI treatment in multiple tertiary care hospitals after Sep 1st, 2019. Patients' clinical information prior to the study initiation in each hospital will be collected retrospectively through chart review. After the study initiation, new patient enrollment will last till Dec 2022. Patients' clinical care after the study initiation will be followed up prospectively until the end of study. The interval of response evaluation is recommended to be every 2 to 3 months in the treatment period and the interval of follow-up is recommended to be every 2 to 3 months in the post-treatment period till the end of study in the prospective data collection period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •A confirmed diagnosis of locally advanced or metastatic NSCLC.
- •The tumor harbored common EGFR mutations (Del19, L858R) at start of first-line treatment
- •Age ≥ 18 years
- •Had never received any EGFR TKI therapy.
- •Patients that treated with dacomitinib (Vizimpro®) as first-line treatment
- •Confirmation of the T790M variant after first line dacomitinib treatment and receive any 3rd generation EGFR-TKI as second-line treatment.
- •Asymptomatic CNS metastases allowed
- •At least one lesion that can be accurately measured at baseline according to the RECIST 1.1, and which is suitable for accurate repeated measurements.
- •Start second-line treatment with third generation EGFR TKI no later than 01 JAN2023（>10 month before data cutoff date）
- •All eligible patients are required to sign an informed consent before initiating the study
排除标准
- •Patients who received drug(s) other than 3rd generation EGFR-TKI as the second-line treatment and/or patients who received drug(s) other than Dacomitinib (Vizimpro®) as the first-line treatment
- •Received or currently receiving dacomitinib from any interventional clinical trial
研究组 & 干预措施
dacomitinib treatment
Sequential Therapy with Dacomitinib as First-line Treatment Followed by 3rd generation EGFR-TKI in Patients with EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer
干预措施: Dacomitinib (Drug)
结局指标
主要结局
time to treatment failure
时间窗: up to 4 years
To describe the time to treatment failure (TTF) of sequential dacomitinib and 3rd generation EGFR-TKI used in patients with EGFR mutation-positive NSCLC and T790M-aquired resistance in China.
次要结局
- overall survival(up to 5 years)
- progression-free survival(up to 4 years)
- duration of treatment(up to 4 years)
研究者
Junling Li
professor
Peking Union Medical College