A Study of Tarceva (Erlotinib) in Combination With Avastin (Bevacizumab) in Patients With Advanced Non-Small Cell Lung Cancer.
2014年11月4日 更新者：Hoffmann-La Roche
A Randomized, Open-label Study Comparing the Anti-tumor Effect of Treatment With Tarceva Plus Avastin Versus Chemotherapy Plus Avastin in Patients With Advanced Non-small Cell Lung Cancer
This 2 arm study will compare the efficacy and safety of Tarceva plus Avastin, and chemotherapy plus Avastin, in the first-line treatment of patients with advanced non-small cell lung cancer.
Patients will be randomized to receive either Tarceva 150mg p.o. daily plus Avastin 15mg/kg i.v.
every 3 weeks, or standard platinum-based chemotherapy (4-6 cycles) plus Avastin.
The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
研究概览
研究类型
介入性
注册 (实际的)
124
阶段
- 阶段2
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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Changhua、台湾、500
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Kaohsiung、台湾、00833
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Tainan、台湾、710
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Taipei、台湾
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Taipei、台湾、114
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Taipei、台湾、112
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Bundang City、大韩民国、463-802
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Daegu、大韩民国、700-712
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Gyeonggi-do、大韩民国、411-769
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Incheon、大韩民国、405-760
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Seoul、大韩民国、138-736
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Seoul、大韩民国、110-744
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Seoul、大韩民国、120-752
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Seoul、大韩民国、135-710
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Seoul、大韩民国、137-807
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Suwon、大韩民国
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Friuli-Venezia Giulia
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Aviano、Friuli-Venezia Giulia、意大利、33081
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Lombardia
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Milano、Lombardia、意大利、20133
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Marche
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Ancona、Marche、意大利、60121
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Toscana
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Lido Di Camaiore、Toscana、意大利、55043
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Singapore、新加坡、119074
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Leuven、比利时、3000
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Bayonne、法国、64100
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Dijon、法国、21079
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Le Mans、法国、72037
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Marseille、法国、13273
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Paris、法国、75674
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Strasbourg、法国、67091
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Vandoeuvre-les-nancy、法国、54511
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Lodz、波兰、91-520
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Lublin、波兰、20-950
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Otwock、波兰、05-400
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Victoria
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East Bentleigh、Victoria、澳大利亚、VIC 3165
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Geelong、Victoria、澳大利亚、3220
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Kaunas、立陶宛、50009
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Vilnius、立陶宛、08660
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Bucuresti、罗马尼亚、022328
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Cluj Napoca、罗马尼亚、400015
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Timisoara、罗马尼亚、1900
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Dudley、英国、DY1 2HQ
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Guildford、英国、GU2 7XX
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Manchester、英国、M2O 4BX
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's Hertogenbosch、荷兰、5211 RW
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Amsterdam、荷兰、1007 MB
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Eindhoven、荷兰、5623 EJ
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Groningen、荷兰、9713 GZ
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Heerlen、荷兰、6419 PC
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Maastricht、荷兰、6229 HX
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Rotterdam、荷兰、3045 PM
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Alicante、西班牙、3010
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Barcelona、西班牙、08035
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La Coruña、西班牙、15006
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Madrid、西班牙、28046
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Madrid、西班牙、28041
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Madrid、西班牙、28222
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Malaga、西班牙、29010
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Sevilla、西班牙、41014
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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:
- adult patients, >=18 years of age;
- advanced (stage IIIb and IV) non-small cell lung cancer;
- measurable disease;
- ECOG PS 0-1.
Exclusion Criteria:
- prior chemotherapy or treatment with another systemic anti-cancer agent;
- radiotherapy within 4 weeks prior to first dose of study treatment;
- CNS metastases;
- other malignancies in past 5 years, except for adequately treated cancer in situ of the cervix, basal or squamous cell skin cancer.
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：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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有源比较器：Bevacizumab, Chemotherapy
Participants received bevacizumab, 15 milligrams (mg) per (/) kilogram (kg), intravenously (IV), on Day 1 of Cycles 1 through 7 until disease progression, unacceptable toxicity, death, or withdrawal.
Participants also received 4 to 6 cycles of a standard platinum-containing regimen of chemotherapy: either gemcitabine, 1250 mg/ square meter (m^2), IV, on Days 1 and 8 of Cycles 1 through 4 or 6, and cisplatin 80 mg/m^2, IV, on Day 1 of Cycles 1 through 4 or 6; or paclitaxel, 200 mg/m^2, IV, and carboplatin area under the curve (AUC) 6 mg/ milliliter (ml) multiplied by (*) minute (min) on Day 1 of Cycles 1 through 4 or 6.
The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
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15 mg/kg, IV, Day 1 of Cycles 1 through 7
其他名称：
At the discretion of the investigator
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实验性的：Bevacizumab, Erlotinib
Participants received bevacizumab, 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 until disease progression, unacceptable toxicity, death, or withdrawal.
Participants also received erlotinib, 150 mg, orally (PO), daily until disease progression, unacceptable toxicity, death, or withdrawal.
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15 mg/kg, IV, Day 1 of Cycles 1 through 7
其他名称：
150 mg, PO, daily
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 |
|---|---|---|
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Percentage of Participants With Disease Progression or Death
大体时间：Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
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Progression-free survival (PFS) was defined as the time from randomization to disease progression or death, from any cause.
Progressive disease (PD) was defined according to Response Criteria in Solid Tumors (RECIST) version (V) 1.0.
For target lesions (TLs), progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment.
For non-target lesions (NTLs), PD was defined as unequivocal progression of existing NTLs.
Participants were censored at the date of last post-baseline (BL) tumor assessment where non-progression was documented.
If no post-BL tumor assessment was available, the participant was censored at date of randomization.
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Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
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PFS
大体时间：Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
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The median time, in weeks, from randomization to PFS event.
Participants were censored at the date of last post-BL tumor assessment where non-progression was documented.
If no post-BL tumor assessment was available, the participant was censored at date of randomization.
PFS was estimated using Kaplan-Meier methodology.
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Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
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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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Percentage of Participants Who Died
大体时间：Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
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Overall survival (OS) was defined as the time from randomization to the date of death, due to any cause.
Participants were censored at final analysis at the date the participant was last known to be alive.
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Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
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OS
大体时间：Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
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The median time, in months, from randomization to OS event.
Participants were censored at final analysis at the date the participant was last known to be alive.
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Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
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Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0
大体时间：Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
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BOR was defined as the best response recorded from randomization until disease progression/recurrence or death, taking as reference for PD the smallest measurement (nadir) recorded since treatment started.
Assignment of PR of CR required confirmation of tumor measurement changes by repeat assessments performed no less than 4 weeks after criteria for response was first met.
For TLs, CR was defined as the disappearance of all TLs; and PR was defined as at least a 30% decrease in the SLD of the TLs, taking BL SLD as reference.
For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels.
The 95% CI for one sample binomial was calculated using the Pearson-Clopper method.
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Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.
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Percentage of Participants With Disease Control According to RECIST V 1.0
大体时间：Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis, 12 months after the last participant's 1st visit
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Disease control was defined as a BOR of CR, PR, or SD according to RECIST V 1.0 for at least 4 weeks at any time during randomized treatment or disease stabilization, after study entry.
Participants without a post-BL assessment of response were considered as having no disease control.
The 95% CI for the one sample binomial was calculated using the Pearson-Clopper method.
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Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis, 12 months after the last participant's 1st visit
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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。
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
2008年1月1日
初级完成 (实际的)
2010年1月1日
研究完成 (实际的)
2010年1月1日
研究注册日期
首次提交
2007年9月18日
首先提交符合 QC 标准的
2007年9月18日
首次发布 (估计)
2007年9月19日
研究记录更新
最后更新发布 (估计)
2014年11月11日
上次提交的符合 QC 标准的更新
2014年11月4日
最后验证
2014年11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.
Bevacizumab的临床试验
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Weill Medical College of Cornell University终止多形性胶质母细胞瘤 | 间变性星形细胞瘤 | 弥漫性脑桥脑胶质瘤 | 脑干胶质瘤 | 毛粘液样星形细胞瘤 | 脑干胶质瘤 | 脑纤维星形细胞瘤 | 混合性少突胶质细胞瘤-星形细胞瘤美国
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Zhejiang Cancer Hospital招聘中
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Sixth Affiliated Hospital, Sun Yat-sen University招聘中