A Study of Erlotinib (Tarceva) Versus Gemcitabine/Cisplatin as First-line Treatment in Patients With Non-small Cell Lung Cancer With EGFR Mutations
2015年2月5日 更新者：Hoffmann-La Roche
A Multicenter, Open-label, Randomized Phase III Study to Evaluate the Efficacy and Safety of Erlotinib (Tarceva®) Versus Gemcitabine/Cisplatin as the First-line Treatment for Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) Patients With Mutations in the Tyrosine Kinase Domain of Epidermal Growth Factor Receptor (EGFR) in Their Tumors
This open-label, randomized, parallel arm study assessed the efficacy and safety of Tarceva (erlotinib) versus gemcitabine/cisplatin combination chemotherapy as first-line treatment in patients with stage IIIB/IV non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations in their tumours.
Patients were randomized to receive either Tarceva 150 mg orally daily or 3-week cycles of gemcitabine 1250 mg/m^2 intravenously (iv) on Days 1 and 8 plus cisplatin 75 mg/m^2 iv on Day 1.
研究概览
研究类型
介入性
注册 (实际的)
217
阶段
- 第三阶段
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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Beijing、中国、101149
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Beijing、中国、100071
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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、510080
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Hangzhou、中国、310016
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Nanjing、中国、210002
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Shanghai、中国、200032
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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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Xi'an、中国、710061
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Davao、菲律宾、8000
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Desmarinas City、菲律宾、4114
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Manila、菲律宾、1000
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Quezon City、菲律宾、1104
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San Juan、菲律宾、1500
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Kelantan、马来西亚、16150
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Kuala Lumpur、马来西亚、59100
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Kuala Lumpur、马来西亚、50603
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Nilai、马来西亚、71800
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Pahang、马来西亚、25100
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Petaling Jaya、马来西亚、46150
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Petaling Jaya, Selangor、马来西亚、46050
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Pulau Pinang、马来西亚、11600
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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 participants, ≥ 18 years of age.
- Locally advanced or recurrent (stage IIIB) or metastatic (stage IV) non-small cell lung cancer.
- Presence of epidermal growth factor receptor (EGFR) mutations in tumours.
- Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria.
- European Cooperative Oncology Group (ECOG) performance status ≤ 2.
Exclusion Criteria:
- Prior exposure to agents directed at the human epidermal receptor (HER) axis (eg, but not limited to erlotinib, gefitinib, cetuximab, or trastuzumab).
- Prior chemotherapy or systemic anti-neoplastic therapy for advanced disease.
- Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or active gastroduodenal ulcer disease.
- Any inflammatory changes of the surface of the eye.
- ≥ Grade 2 peripheral neuropathy.
- History of any other malignancies within 5 years, except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer.
- Brain metastasis or spinal cord compression that has not yet been definitely treated with surgery and/or radiation, or treated but without evidence of stable disease for at least 2 months.
- Human immunodeficiency virus (HIV) infection.
- Pregnant, nursing, or lactating women.
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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实验性的：Erlotinib
Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
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Erlotinib was supplied as tablets.
其他名称：
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有源比较器：Chemotherapy
Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
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Cisplatin and gemcitabine were locally sourced with commercial products.
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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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Investigator-assessed Duration of Progression-free Survival
大体时间：Baseline to the data cut-off date of 20 Jul 2012 (1 year, 4 months)
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The duration of progression-free survival was defined as the time from randomization to disease progression (PD) or death from any cause, whichever occurs first.
PD was defined as: (1) At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum).
The sum must also demonstrate an absolute increase of at least 5 mm.
(2) An unequivocal progression of existing non-target lesions.
When the patient has measurable disease, the overall tumor burden must have increased sufficiently to merit discontinuation of therapy.
When the patient has only non-measurable disease, the increase in overall disease burden should be comparable in magnitude to the increase that would be required to declare PD for measurable disease.
(3) The appearance of new malignant lesions.
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Baseline to the data cut-off date of 20 Jul 2012 (1 year, 4 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 Responders as Assessed by the Investigator
大体时间：Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)
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A responder was defined as a participant with either a complete response (CR) or a partial response (PR), as determined using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
A CR was defined as: (1) The disappearance of all target lesions.
Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to < 10 mm.
(2) The disappearance of all non-target lesions and normalization of tumor marker levels.
All lymph nodes must be non-pathological in size (< 10 mm in the short axis).
A PR was defined as: (1) At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
(2) The persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker levels above normal limits.
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Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)
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Percentage of Participants With Disease Control
大体时间：Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)
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A participant with disease control was defined as a participant with either a complete response (CR), a partial response (PR), or stable disease (SD), as determined using RECIST v1.1.
A CR was defined as the disappearance of all target lesions (TL).
A PR was defined as at least a 30% decrease in the sum of the longest diameter of TLs taking as reference the Baseline sum longest diameter (SLD).
SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest SLD since treatment started.
For non-TLs, SD was defined as the persistence of 1 or more lesions.
PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs.
A SLD for all TLs will be calculated and reported as the Baseline SLD.
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Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)
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Duration of Response
大体时间：Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)
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Duration of response was defined as the time from the first documented complete response (CR) or partial response (PR) to the first documented disease progression (PD) or death, whichever occurs first.
A CR was defined as the disappearance of all target lesions (TL).
A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs taking as reference the Baseline SLD.
PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs.
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Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)
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Overall Survival
大体时间：Baseline to the end of the study (3 years, 1 month)
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Overall survival was defined as the time from the date of randomization to the date of death from any cause.
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Baseline to the end of the study (3 years, 1 month)
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Safety: Incidence of Adverse Events
大体时间：36 months
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36 months
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Quality of Life: Functional Assessment of Chronic Illness Therapy - Lung (FACIT-L) Questionnaire
大体时间：approximately 21 months
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approximately 21 months
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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。
一般刊物
- Wen F, Zheng H, Zhang P, Hutton D, Li Q. OPTIMAL and ENSURE trials-based combined cost-effectiveness analysis of erlotinib versus chemotherapy for the first-line treatment of Asian patients with non-squamous non-small-cell lung cancer. BMJ Open. 2018 Apr 13;8(4):e020128. doi: 10.1136/bmjopen-2017-020128.
- Wu YL, Zhou C, Liam CK, Wu G, Liu X, Zhong Z, Lu S, Cheng Y, Han B, Chen L, Huang C, Qin S, Zhu Y, Pan H, Liang H, Li E, Jiang G, How SH, Fernando MCL, Zhang Y, Xia F, Zuo Y. First-line erlotinib versus gemcitabine/cisplatin in patients with advanced EGFR mutation-positive non-small-cell lung cancer: analyses from the phase III, randomized, open-label, ENSURE study. Ann Oncol. 2015 Sep;26(9):1883-1889. doi: 10.1093/annonc/mdv270. Epub 2015 Jun 23.
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
2011年3月1日
初级完成 (实际的)
2012年7月1日
研究完成 (实际的)
2014年4月1日
研究注册日期
首次提交
2011年4月26日
首先提交符合 QC 标准的
2011年4月26日
首次发布 (估计)
2011年4月27日
研究记录更新
最后更新发布 (估计)
2015年2月24日
上次提交的符合 QC 标准的更新
2015年2月5日
最后验证
2015年2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.