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A Retrospective, Non-interventional, Multicenter, Observational Chart Review Study to Explore the Clinical Benefits of Retreatment With TKI in the Real World. (SEQUENCE)

2015年11月3日更新者：AstraZeneca

A Retrospective, Non-interventional Study to Evaluate EGFR-Tyrosine Kinase Inhibitor Retreatment in Patients With Locally Advanced or Metastatic EGFR Mutated NSCLC Who Previously Treated With EGFR-TKI as First-line Therapy and Chemotherapy as Second-line Therapy - SEQUENCE Study

This is a retrospective, non-interventional, multicenter, observational chart review study to explore the clinical benefits of retreatment with TKI in the real world.

研究概览

地位

完全的

条件

Locally Advanced or Metastatic EGFR Mutated NSCLC.

详细说明

This study is designed to retrospectively review the medical and chemotherapy records of 300 patients with EGFR mutation positive adenocarcinoma NSCLC. Eligible patients are as follows: histologically or cytologically confirmed NSCLC, undergone EGFR-TKI retreatment sometime after the failure of the initial EGFR-TKI. After initial treatment, patients had been treated with chemotherapy and subsequently re-treated with EGFR-TKI will be identified. The target population will be derived from multicentre in Taiwan. The study aim is to evaluate clinical effect in re-administration of EGFR-TKI using retrospectively collected data from these eligible patients to provide valuable information.

研究类型

观察性的

注册 (预期的)

200

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

台湾
- - Chiayi、台湾
  - Kaohsiung、台湾
  - Taichung、台湾
  - Taipei、台湾
  - Taipei、台湾
    - Research Site
  - Tao Yuan、台湾

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

20年至 150年 (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

Patients with locally advanced or metastatic Epidermal Growth Factor Receptor mutated Non-small-cell Lung Cancer who Previously Treated with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor as First-line therapy and chemotherapy as second-line Therapy - SEQUENCE study

描述

Inclusion Criteria:

Patients diagnosed with advanced adenocarcinoma or positive result of thyroid transcription factor 1 NSCLC
Positive Epidermal Growth Factor Receptor mutation result with sensitive mutation
Female or male aged ≧20 years
Patients treated with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor and subsequently treated with chemotherapy before re-administration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor. Exclusion Criteria:

1. Patients with EGFR mutation status of positive exon 20 T790M mutation only. 2. Patients who are confirmed of squamous type NSCLC

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

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
The treatment duration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor re-administration 大体时间：From the start of re-administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.	The median duration of re-administration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor will be summarized by days or months, if applicable. The range of this treatment duration will also be presented. All analyses will be performed on all eligible patients in this study.	From the start of re-administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.

次要结果测量

结果测量	措施说明	大体时间
Assessment of progression-free survival for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments. 大体时间：From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.	The outcome of progression-free survival will be presented with median values and associated 95% CIs by Kaplan-Meier curve. PFS is defined as the time interval (in weeks) from the start date of a given treatment to the date of disease progression or death, respectively, which one is observed first. Subjects who did not progress or die without a reported progression will be censored on the date of their last tumor assessment.	From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
Assessment of overall survival for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments. 大体时间：From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.	The outcome of overall survival will be presented with median values and associated 95% CIs by Kaplan-Meier curve. OS is defined as the time interval (in weeks) from the beginning of treatment until the date when death or lost to follow up is observed. For those subjects who have not died or lost to follow-up, survival duration will be censored at the last date the subject was known to be alive.	From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
Assessment of response rate for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments. 大体时间：From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.	The outcome about response rate and the proportion of response rate are estimated by all evaluable patients. The 95% exact confidence interval will be constructed around the rates. The best response during treatment sequences is determined in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.	From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
Assessment of disease control rate for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments. 大体时间：From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.	The outcome of disease control rate are estimated by all evaluable patients. The 95% exact confidence interval will be constructed around the rates. Disease Control Rate is defined as patients who are respond to treatment (including CR-complete respond, PR-partial respond or SD- Stable Disease).	From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
Record treatment duration in the initial EGFR-TKI therapy and first time chemotherapy. 大体时间：Between the initial EGFR-TKI therapy and first time chemotherapy.	Treatment duration in the initial EGFR-TKI therapy and first time chemotherapy.	Between the initial EGFR-TKI therapy and first time chemotherapy.
Record the reason(s) for treatment change for initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment). 大体时间：From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.	Record the reason(s) for treatment change for initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment).	From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
Explore relationships between efficacy of EGFR-TKI initial and re-administration and patient characteristics or EGFR TKI treatment characteristics. 大体时间：EGFR-TKI initial and re-administration	Explore relationships between efficacy of EGFR-TKI initial and re-administration and patient characteristics (including demographics, histology, disease stage, sites of metastasis, ECOG PS) or EGFR TKI treatment characteristics (including EGFR mutation pattern, response to initial EGFR TKI or not, length of duration between first and second EGFR-TKI treatment)	EGFR-TKI initial and re-administration
overall survival (OS), plasma CEA level and chemotherapy regimens ever used. 大体时间：between first time chemotherapy and EGFR-TKI re-administration	Explore overall survival (OS), plasma CEA level and chemotherapy regimens ever used between first time chemotherapy and EGFR-TKI re-administration (including the types and number of chemotherapy regimens, and treatment duration) for those patients who have the above data available.	between first time chemotherapy and EGFR-TKI re-administration
image peer review to evaluate tumour size retrospectively in different sequences of treatment 大体时间：(1) initial and re-administration of EGFR-TKI therapy, (2) first time chemotherapy ever used (second-line treatment) after initial EGFR-TKI treatment.	If the images are available, conduct image peer review to evaluate tumour size retrospectively in different sequences of treatment: (1) initial and re-administration of EGFR-TKI therapy, (2) first time chemotherapy ever used (second-line treatment) after initial EGFR-TKI treatment. Peer review time point includes baseline, best response and progression of last image while stopping treatment at each treatment mentioned above.	(1) initial and re-administration of EGFR-TKI therapy, (2) first time chemotherapy ever used (second-line treatment) after initial EGFR-TKI treatment.
The reason(s) for the treatment change for initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment) after peer review 大体时间：Initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment) after peer review.	Evaluate the reason(s) for the treatment change for initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment) after peer review and compare the difference of reason(s) for the treatment change between initiatial evaluation and after peer review.	Initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment) after peer review.

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。

赞助

AstraZeneca

调查人员

首席研究员：Te-Chun Hsia、China Medical University Hospital
首席研究员：Yuh-Min Chen、Taipei Veterans General Hospital, Taiwan
首席研究员：Gee-Chen Chang、Veterans General Hospital -Taichung
首席研究员：Chong-Jen Yu、National Taiwan University Hospital
首席研究员：Cheng-Ta Yang、Chang Gung Memorial Hospital
首席研究员：Meng-Chih Lin、Chang-Gung Memorial Hospital Kaohsiung
首席研究员：Ying-Huang Tsai、Chang-Gung Memorial Hospital ChiaYi

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。

有用的网址

CSR_Synopsis_NIS-OTW-XXX-2013_1

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

2013年12月1日

初级完成 (实际的)

2014年8月1日

研究完成 (实际的)

2014年8月1日

研究注册日期

首次提交

2013年9月30日

首先提交符合 QC 标准的