Afatinib Osimertinib Sequencing NIS
2020年12月23日 更新者：Boehringer Ingelheim
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
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.
研究概览
研究类型
观察性的
注册 (实际的)
204
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Vienna、奥地利、1140
- Otto-Wagner Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Study is planned that around 65 study centres in 11 countries will be participating in this noninterventional study and at least 190 consecutive eligible patients will be enrolled to the study.
Every patient who fulfils inclusion and exclusion criteria and agree to participate in the study (if a written informed consent is required for this NIS by local regulation and legal requirement) will be selected until the required sample size is achieved.
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
patients with EGFR mutation-positive NSCLC
(Non-Small Cell Lung Cancer) (Epidermal Growth Factor Receptor)
|
GILOTRIF, GIOTRIF, XOVOLTIB
on T790M resistance mutation was developed
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time on Treatment With Afatinib (Gi(l)Otrif®) Followed by Osimertinib
大体时间：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. |
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.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The Percentage of Participants With Different Types of Mutations After Categorisation
大体时间：Data collected from start of treatment until data entry completion; up to 96.8 months.
|
Different types of resistance mutations identified at the time of discontinuation of osimertinib treatment were systematically reviewed and categorised.
|
Data collected from start of treatment until data entry completion; up to 96.8 months.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Hochmair MJ, Morabito A, Hao D, Yang CT, Soo RA, Yang JC, Gucalp R, Halmos B, Marten A, Cufer T. Sequential afatinib and osimertinib in patients with EGFR mutation-positive non-small-cell lung cancer: final analysis of the GioTag study. Future Oncol. 2020 Dec;16(34):2799-2808. doi: 10.2217/fon-2020-0740. Epub 2020 Aug 28.
- Feinberg B, Halmos B, Gucalp R, Tang W, Moehring B, Hochmair MJ. Making the case for EGFR TKI sequencing in EGFR mutation-positive NSCLC: a GioTag study US patient analysis. Future Oncol. 2020 Aug;16(22):1585-1595. doi: 10.2217/fon-2020-0188. Epub 2020 Aug 6.
- Yamamoto N, Mera T, Marten A, Hochmair MJ. Observational Study of Sequential Afatinib and Osimertinib in EGFR Mutation-Positive NSCLC: Patients Treated with a 40-mg Starting Dose of Afatinib. Adv Ther. 2020 Feb;37(2):759-769. doi: 10.1007/s12325-019-01187-y. Epub 2019 Dec 20.
- Hochmair MJ, Morabito A, Hao D, Yang CT, Soo RA, Yang JC, Gucalp R, Halmos B, Wang L, Marten A, Cufer T. Sequential afatinib and osimertinib in patients with EGFR mutation-positive non-small-cell lung cancer: updated analysis of the observational GioTag study. Future Oncol. 2019 Sep;15(25):2905-2914. doi: 10.2217/fon-2019-0346. Epub 2019 Aug 2.
- Hochmair MJ, Morabito A, Hao D, Yang CT, Soo RA, Yang JC, Gucalp R, Halmos B, Wang L, Golembesky A, Marten A, Cufer T. Sequential treatment with afatinib and osimertinib in patients with EGFR mutation-positive non-small-cell lung cancer: an observational study. Future Oncol. 2018 Nov;14(27):2861-2874. doi: 10.2217/fon-2018-0711. Epub 2018 Oct 19.
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年12月28日
初级完成 (实际的)
2019年11月28日
研究完成 (实际的)
2019年11月28日
研究注册日期
首次提交
2017年12月7日
首先提交符合 QC 标准的
2017年12月7日
首次发布 (实际的)
2017年12月12日
研究记录更新
最后更新发布 (实际的)
2020年12月24日
上次提交的符合 QC 标准的更新
2020年12月23日
最后验证
2020年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.