Afatinib as Second-line Therapy for Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation
2018年6月1日 更新者：Boehringer Ingelheim
An Open Label, Single-arm Phase IV Study to Assess the Efficacy and Safety of Afatinib as Second-line Therapy for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harbouring an EGFR Mutation (Del19 or L858R) Who Have Failed First-line Treatment With Platinum-based Chemotherapy
The objectives of this single-arm, open-label trial are to assess the efficacy and safety of afatinib as second line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring a common EGFR mutation who have failed first-line platinum-based chemotherapy and to demonstrate that the efficacy and safety are comparable to the results seen in previous trials.
研究概览
研究类型
介入性
注册 (实际的)
60
阶段
- 第四阶段
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
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Alexandria、埃及、21131
- Clinical Research Center, Alexandria University Hospital
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Cairo、埃及、11796
- National Cancer Institute, Cairo University
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Cairo、埃及、12311
- Kasr Al Ainy Hospital
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Belgrade、塞尔维亚、11000
- Institute for Oncol & Radiol of Serbia, Clinic f. Med. Onco.
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Belgrade、塞尔维亚、11129
- Clinical Center of Serbia
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Kragujevac、塞尔维亚、34000
- Clinical Center Kragujevac
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Sremska Kamenica、塞尔维亚、21204
- Inst. for Pulm. Diseases of Vojvodine, Clinic f. Pulm. Oncol
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Gdansk、波兰、80-952
- University Clinical Center, Gdansk
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Szczecin-Zdunowo、波兰、70-891
- Specialist Hospital, Szczecin-Zdunowo
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Warsaw、波兰、02-781
- Oncol Centre M Sklodowska-Curie, Dept of Lung & Chest Cancer
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Bangkok、泰国、10330
- King Chulalongkorn Memorial Hospital
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Bangkok、泰国、10400
- Rajavithi Hospital
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Bangkok、泰国、10310
- Wattanosoth Hospital
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Songkhla、泰国、90110
- Songklanagarind Hospital
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Braila、罗马尼亚、810303
- Braila County Emergency Hospital, Medical Oncology
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Bucharest、罗马尼亚、022328
- Institute of Oncology 'Prof. Dr. Alexandru Trestioreanu'
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Craiova、罗马尼亚、200347
- Sf. Nectarie Oncology Center, Craiova
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Iasi、罗马尼亚、700483
- Regional Oncology Institute of Iasi, Medical Oncology
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Baguio City、菲律宾、2600
- Baguio General Hospital and Medical Center
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Taguig、菲律宾、1634
- St. Luke's Medical Center
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Nilai、马来西亚、71800
- Nilai Medical Centre
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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
描述
Inclusion criteria:
- Pathologically confirmed diagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV adenocarcinoma of the lung. Patients with mixed histology are eligible if adenocarcinoma is the predominant histology.
- Documented EGFR mutation (L858R and/or Deletion 19) with no other known EGFR mutation.
- Measureable disease according to RECIST 1.1.
- Radiologically confirmed progression or recurrence of disease during or following first line therapy with a platinum-based chemotherapy regimen.
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
- Adequate organ function.
Exclusion criteria:
- More than one line of prior therapy for disease.
- Previously received less than 3 cycles of platinum-based chemotherapy due to toxicity and/or intolerance of treatment.
- Previous treatment with any EGFR targeting Tyrosine Kinase Inhibitor (TKI) or antibody.
- Known pre-existing interstitial lung disease.
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
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Afatinib
Afatinib tablet once daily until progression
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Afatinib tablet once daily until progression
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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 |
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Objective Tumour Response (Complete Response [CR], Partial Response [PR]) as Assessed by the Investigator According to the RECIST Version 1.1
大体时间：Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days
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As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), =30% decrease in the sum of the longest diameter of target lesions
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Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Progression-free Survival (PFS) as Assessed by the Investigator According to RECIST 1.1.
大体时间：Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days
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Progression-free survival (PFS) is the time from treatment start to disease progression (or death if the patient died before progression).
PFS as assessed based on investigator review according to the response evaluation criteria in solid tumours (RECIST) version 1.1.
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Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days
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Disease Control (CR, PR, Stable Disease [SD]) as Assessed by the Investigator According to RECIST 1.1
大体时间：Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days
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As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), =30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.
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Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days
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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。
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)
2014年10月2日
初级完成 (实际的)
2017年5月17日
研究完成 (实际的)
2017年6月13日
研究注册日期
首次提交
2014年8月4日
首先提交符合 QC 标准的
2014年8月4日
首次发布 (估计)
2014年8月5日
研究记录更新
最后更新发布 (实际的)
2018年12月17日
上次提交的符合 QC 标准的更新
2018年6月1日
最后验证
2018年6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.