Progression Free Survival (PFS) Using Erlotinib for Non-Small-Cell Lung Cancer (NSCLC) in Chinese Population
Ensure Extension Study to Assess the PFS of First-Line Erlotinib (Tarceva®) and Erlotinib After the Time of Disease Progression in Chinese Population Enrolled in the Ensure Trial
This trial is an extension to ENSURE, a study of erlotinib versus gemcitabine/cisplatin combination chemotherapy as the first-line treatment for patients with non-small-cell lung cancer (NSCLC) with mutations in the tyrosine kinase domain of EGFR.
This study is designed to examine the efficacy of erlotinib versus gemcitabine/cisplatin as a second-line treatment in NSCLC patients from the ENSURE trial (NCT01342965). Patients previously treated with gemcitabine/cisplatin will be given erlotinib daily until disease progression or unacceptable toxicity occurs. Patients previously treated with erlotinib will be given cisplatin on Day 1 and gemcitabine on Days 1 and 8 of 3-week chemotherapy cycles until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first).
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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-
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Beijing、中国、101149
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Changchun、中国、130012
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ChongQing、中国、400042
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Chongqing、中国、400038
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Fuzhou、中国、350014
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Guangzhou、中国
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Nanjing、中国
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Shanghai、中国、200433
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Shanghai、中国、200030
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Shantou、中国、515041
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Wuhan、中国、430023
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Participant in ENSURE trial
- Disease progression during first-line treatment
Exclusion Criteria:
- N/A
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 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：Erlotinib-Chemotherapy
Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment
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150 mg oral dose of erlotinib given once daily
其他名称：
Cisplatin (75 mg/m^2 intravenously [IV]) on Day 1 and gemcitabine (1250 mg/m^2 IV) on Days 1 and 8 of 3-week chemotherapy cycles until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first)
其他名称：
|
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有源比较器：Chemotherapy-Erlotinib
Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
|
150 mg oral dose of erlotinib given once daily
其他名称：
Cisplatin (75 mg/m^2 intravenously [IV]) on Day 1 and gemcitabine (1250 mg/m^2 IV) on Days 1 and 8 of 3-week chemotherapy cycles until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first)
其他名称：
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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 |
|---|---|---|
|
Progression Free Survival (PFS) Based on Well-documented and Verifiable Progression Events
大体时间：within 3 years, 9 months (data cut-off December 2014)
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Progression free survival is defined as the time of randomization in ENSURE study to progressive disease (PD) while on second-line treatment or death from any cause, whichever occurred first during the second-line treatment.
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within 3 years, 9 months (data cut-off December 2014)
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Participants With Adverse Events
大体时间：start of second-line treatment to data cut-off in December 2014 (within 12 months)
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start of second-line treatment to data cut-off in December 2014 (within 12 months)
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
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.