J-REGISTER: Japanese REal-world Data for Treatment of Afatinib (GIotrif®) in First-line Setting and Subsequent Therapies for Patients With Advanced EGFR Mutation-positive Lung Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 805
- 试验地点
- 1
- 主要终点
- Time on Treatment (TOT) With Afatinib in First-line TOT (TOT1)
研究概览
简要总结
The primary objective is to confirm Time on Treatment (TOT) related to afatinib treatment as first-line therapy in patients with Epidermal Growth Factor Receptor (EGFR) mutation-positive Non-Small Cell Lung Cancer (NSCLC).
The observation in the real-world setting of the time from the start of the first-line afatinib until the end of subsequent treatment in this study will provide insights on the sequence of treatment for patients. The Japanese healthcare system will enable this study to evaluate multiple treatment options after afatinib treatment.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Epidermal Growth Factor Receptor (EGFR) mutation-positive advanced Non-Small Cell Lung Cancer (NSCLC)
- •Patients who were/are treated with afatinib in the first-line setting at least 20 months* prior to data entry
- •Patients 20 years of age or older at the time of consent
- •Patients who provided consent to participate in this study (for cases of death or lost to follow-up, instructions from the Ethic Committee (EC)/Institutional Review Board (IRB) at each site should be followed) * Inclusion will be restricted to patients with treatment initiation with afatinib at least 20 months prior to enrolment to avoid early censoring.
排除标准
- •Any contraindication to afatinib as specified in the label of Giotrif®
- •Patients treated with afatinib within an interventional trial
- •Patients with active brain metastases at start of afatinib treatment* * Patients with non-active brain metastases (asymptomatic state) are eligible.
研究组 & 干预措施
patients treated with afatinib
干预措施: afatinib (Drug)
结局指标
主要结局
Time on Treatment (TOT) With Afatinib in First-line TOT (TOT1)
时间窗: From start of afatinib as first line treatment up to 18 months and up to 36 months.
Time on Treatment (TOT) with afatinib in first-line TOT (TOT1). This was assessed as the time from the start of afatinib as first-line treatment until the end of afatinib treatment or death date by any cause, whichever occurs first. If patients did not discontinue first-line treatment with afatinib and did not die at the data extraction, they were censored on the date they were last verified to have been on first-line treatment with afatinib. The survival probability rate (95% confidence interval) against time to first-line treatment failure at 18 months and at 36 months is reported.
次要结局
- Time on Treatment From the Start of Afatinib Until End of Subsequent Therapies in the Second-line Setting or Death by Any Cause (TOT)(From start of afatinib up to 18 months and up to 36 months.)
- Time on Treatment From Start of the Second-line Treatment Until End of the Second-line Treatment or Death by Any Cause (TOT2)(From start of afatinib as second line treatment up to 18 months and up to 36 months.)
- Overall Survival(From start of afatinib up to 18 months and up to 36 months.)
- Time to Initial Dose Reduction of Afatinib(From start of afatinib up to 18 months and up to 36 months.)
- Percentage of Participants With Dose Modifications of Afatinib(From start of data extraction until end of data extraction, up to 586 days.)