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Gefitinib Long-term Survivor Study

2022年3月9日更新者：AstraZeneca

A Study of Clinical and Genomic Analysis on Long-term Survivors of EGFR Mutation Positive Advanced Non-small-cell Lung Cancer Patients With Gefitinib Treatment in China

The primary objective is to describe the genomic profile of long-term survivors, especially to find out potential genomic prognosis and/or predictive factors for gefitinib long-term efficacy as compared to rapid PD patients

研究概览

地位

终止

条件

EGFR Mutation Positive Advanced Non-small-cell Lung Cancer

研究类型

观察性的

注册 (实际的)

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

中国
- Beijing
  - Beijing、Beijing、中国
    - Research Site
- Fujian
  - Fuzhou、Fujian、中国
    - Research Site
- Guangdong
  - Guangzhou、Guangdong、中国
    - Research Site
- He Nan
  - Zhengzhou、He Nan、中国
    - Research Site
- Hebei
  - Shijiazhuang、Hebei、中国
    - Research Site
- Hubei
  - Wuhan、Hubei、中国
    - Research Site
- Jiangsu
  - Nanjing、Jiangsu、中国
    - Research Site
- Jilin
  - Changchun、Jilin、中国
    - Research Site
- Liaoning
  - Shenyang、Liaoning、中国
    - Research Site
- Shaanxi
  - XI An、Shaanxi、中国
    - Research Site
- Shanghai
  - Shanghai、Shanghai、中国
    - Research Site
- Shanxi
  - Taiyuan、Shanxi、中国
    - Research Site
- Sichuan
  - Chengdu、Sichuan、中国
    - Research Site
- Zhejiang
  - Hangzhou、Zhejiang、中国
    - Research Site

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

孩子
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

This study will recruit approximately 150 aNSCLC patients who fulfil the inclusion/exclusion criteria

描述

Inclusion Criteria:

For inclusion in the long-term survivors group, the study subjects must fulfil the following criteria at the time of screening:

Provision of informed consent or EC approve informed consent waiver prior to any study specific procedures
Histological or cytological confirmed locally advanced NSCLC (stage III B) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy
EGFR mutation positive
Patients who continuously received gefitinib for at least 3 years without evidence of PD
Patients with OS ≥ 5 years from NSCLC diagnosis will be preferred
Collect archival tumour tissue before gefitinib treatment (blood and re-biopsy tumour tissue are optional); tumor tissue samples requirements: 1) slices requirements: >1 cm2, thickness 4-5 μm, ≥ 15 slices. or, whole FFPE block; 2) tumor percentage > 20% and necrosis < 30% by pathology QC.

For inclusion in the rapid PD group, the study subjects must fulfil the following criteria:

Provision of informed consent or EC approve informed consent waiver prior to any study specific procedures
Histological or cytological confirmed locally advanced NSCLC (stage III B) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy
EGFR mutation positive
Patients who had undergone PD after gefitinib treatment≤3 months (Rapid PD)
Collect archival tumour tissue before gefitinib treatment (blood and re-biopsy tumour tissue samples are optional) ; tumor tissue samples requirements: 1) slices requirements: >1 cm2, thickness 4-5 μm, ≥ 15 slices. or, whole FFPE block; 2) tumor percentage > 20% and necrosis < 30% by pathology QC.

Exclusion Criteria:

For the active patients, who must not enter the study if any of the following exclusion criteria are fulfilled 1. Patients who disagree to participate this study.

For the terminated patients, who must not enter the study if any of the following exclusion criteria are fulfilled

1. Patients in whose medical objection was recorded to use the existing data from medical practice for scientific research.

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

团体/队列数

队列和干预

团体/队列
Long-term survivors group (case) EGFR M+ aNSCLC patients who continuously received gefitinib for at least 3 years
Rapid PD group (control) EGFR M+ aNSCLC patients who had undergone PD after gefitinib treatment≤3 months

研究衡量的是什么？

主要结果指标

结果测量	大体时间
Proportion of patients with specific genomic alterations(mutation, copy number change and fusion) of short or long-term survivors 大体时间：at time of sample collection before Gefitinib treatment initiation, up to 10 years before study start	at time of sample collection before Gefitinib treatment initiation, up to 10 years before study start

次要结果测量

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

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)

2016年10月31日

初级完成 (实际的)

2017年7月4日

研究完成 (实际的)

2017年7月4日

研究注册日期

首次提交

2016年9月12日

首先提交符合 QC 标准的

2016年10月11日

首次发布 (估计)

2016年10月13日

研究记录更新

最后更新发布 (实际的)

2022年3月24日

上次提交的符合 QC 标准的更新

2022年3月9日

最后验证

2021年12月1日

结果测量	大体时间
Sex 大体时间：at time of Gefitinib treatment initiation,up to 10 years before study start	at time of Gefitinib treatment initiation,up to 10 years before study start
Age 大体时间：at time of Gefitinib treatment initiation, up to 10 years before study start	at time of Gefitinib treatment initiation, up to 10 years before study start
Pre-existing comorbidities at initiation of gefitinib therapy 大体时间：at time of Gefitinib treatment initiation, up to 10 years before study start	at time of Gefitinib treatment initiation, up to 10 years before study start
Cancer type and date of first ever cancer diagnosis 大体时间：at time of Gefitinib treatment initiation, up to 10 years before study start	at time of Gefitinib treatment initiation, up to 10 years before study start
Histological subtype 大体时间：at time of Gefitinib treatment initiation, up to 10 years before study start	at time of Gefitinib treatment initiation, up to 10 years before study start
Location(s) of metastatic disease at initiation of gefitinib therapy for subjects with TNM stage IV disease 大体时间：at time of Gefitinib treatment initiation, up to 10 years before study start	at time of Gefitinib treatment initiation, up to 10 years before study start
EGFR mutation status 大体时间：at time of Gefitinib treatment initiation, up to 10 years before study start	at time of Gefitinib treatment initiation, up to 10 years before study start
Smoking status 大体时间：at time of Gefitinib treatment initiation, up to 10 years before study start	at time of Gefitinib treatment initiation, up to 10 years before study start
ECOG performance status at time of Gefitinib treatment initiation 大体时间：at time of Gefitinib treatment initiation, up to 10 years before study start	at time of Gefitinib treatment initiation, up to 10 years before study start
Gefitinib treatment patterns- Starting dose 大体时间：at time of Gefitinib treatment initiation, up to 10 years before study start	at time of Gefitinib treatment initiation, up to 10 years before study start
Gefitinib treatment patterns- Dose reductions, treatment interruptions, discontinuation including reasons 大体时间：from Gefitinib treatment initiation to Gefitinib treatment discontinuation or study completion, whichever occurred first, up to 12 years	from Gefitinib treatment initiation to Gefitinib treatment discontinuation or study completion, whichever occurred first, up to 12 years
Gefitinib treatment patterns- Types of other systemic therapies given in combination with gefitinib 大体时间：from Gefitinib treatment initiation to Gefitinib treatment discontinuation or study completion, whichever occurred first, up to 12 years	from Gefitinib treatment initiation to Gefitinib treatment discontinuation or study completion, whichever occurred first, up to 12 years
Therapeutic agent name post-gefitinib discontinuation 大体时间：from gefitinib discontinuation to one year post- gefitinib discontinuation, around one year	from gefitinib discontinuation to one year post- gefitinib discontinuation, around one year
Documented tumour response (complete or partial response or stable disease, according to RECIST) as determined by the treating physician by clinical judgment and/or imaging after first ever initiation of gefitinib 大体时间：from Gefitinib treatment initiation to study completion, up to 12 years	from Gefitinib treatment initiation to study completion, up to 12 years
Progression Free Survival (PFS) 大体时间：from Gefitinib treatment initiation to disease progression or study completion, whichever occurred first, up to 12 years	from Gefitinib treatment initiation to disease progression or study completion, whichever occurred first, up to 12 years
Overval survival (OS) 大体时间：from Gefitinib treatment initiation to death or study completion, whichever occurred first, up to 12 years	from Gefitinib treatment initiation to death or study completion, whichever occurred first, up to 12 years