GioTag: Real-world Data Study on Sequential Therapy With Gi(l)Otrif®/ Afatinib as First-line Treatment Followed by Osimertinib in Patients With EGFR Mutation Positive Advanced Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Time on Treatment With Afatinib (Gi(l)Otrif®) Followed by Osimertinib
研究概览
简要总结
This is a non-interventional, multi-country, multi-centre cohort study based on existing data from medical records of patients with EGFR mutation-positive advanced NSCLC treated with afatinib (Gi(l)otrif®) as the first-line treatment followed by osimertinib in case the T790M resistance mutation was developed.
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
- •Patients with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC)
- •The tumour harbours common EGFR mutations (Del19, L858R) at start of first-line treatment
- •Patients who initiated second-line osimertinib treatment for acquired T790M mutation at least 10 months prior to data entry, AND who were treated with afatinib (Gi(l)otrif®) in the first-line
- •Patients treated with osimertinib within an EAP/CUP or regular clinical practice
- •Age ≥ 18 years
- •Signed and dated written informed consent per regulations (Exemption of a written informed consent for NIS based on existing data in countries per local regulations and legal requirements)
排除标准
- •Patients who received drug(s) other than osimertinib as the second-line treatment and/or patients who received drug(s) other than afatinib (Gi(l)otrif®) as the first-line treatment
- •Patients with active brain metastases at start of treatment (either afatinib/Gi(l)otrif® or osimertinib)
研究组 & 干预措施
patients with EGFR mutation-positive NSCLC
(Non-Small Cell Lung Cancer) (Epidermal Growth Factor Receptor)
干预措施: Afatinib (Drug)
patients with EGFR mutation-positive NSCLC
(Non-Small Cell Lung Cancer) (Epidermal Growth Factor Receptor)
干预措施: Osimertinib (Drug)
结局指标
主要结局
Time on Treatment With Afatinib (Gi(l)Otrif®) Followed by Osimertinib
时间窗: Data collected from start of treatment until data entry completion, up to 96.8 months for first analysis and up to 114.1 months for the extension analysis.
Time on treatment, which was defined as time in months from the start date of Afatinib (Gi\[l\]otrif®) treatment ('start date of initial dose' for First-Line Treatment) to the end date of Osimertinib treatment (maximum between 'end date of initial dose' and the last 'end date of dose modification' for Second-Line Treatment) or death date due to any cause ('date of death'). Time on treatment (months) = Time on treatment (days)/30.4375. 'Time on treatment was analysed using Kaplan-Meier method, and the median along with two-sided 90% confidence interval was displayed using the Greenwood's formula for estimation of standard errors.
次要结局
- The Percentage of Participants With Different Types of Mutations After Categorisation(Data collected from start of treatment until data entry completion; up to 96.8 months.)