NCT00257608已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Phase IIIb Trial Comparing Bevacizumab Therapy With or Without Erlotinib After Completion of Chemotherapy With Bevacizumab for the First-Line Treatment of Locally Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,145
- 试验地点
- 241
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
This is a Phase IIIb, multicenter, randomized, placebo-controlled trial to evaluate the safety and efficacy of chemotherapy+bevacizumab followed by bevacizumab+erlotinib versus bevacizumab+erlotinib placebo in subjects with locally advanced or metastatic NSCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent Form
- •Histologically or cytologically confirmed NSCLC
- •Advanced NSCLC or recurrent disease
- •INR no greater than 1.3 and aPTT no greater than upper limits of normal (ULN) within 28 days prior to enrollment for subjects not on low molecular weight heparin or fondaparinux. Subjects on low molecular weight heparin or fondaparinux are not required to meet INR or aPTT limits. Chronic full-dose anticoagulation with warfarin is not permitted.
- •18 years of age or older
- •For women of childbearing potential and sexually active men, use of an accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to enrollment and for the duration of the study
排除标准
- •Prior systemic chemotherapy in the metastatic setting
- •Treatment with an investigational or marketed agent that acts by either EGFR inhibition or anti-angiogenesis mechanisms
- •Pregnancy or lactation
- •Any other medical condition, including mental illness or substance abuse, deemed by the clinician to be likely to interfere with a subject's ability to provide informed consent, cooperate, and participate in the study, or to interfere with the interpretation of the results
- •Active infection or a fever within 3 days of enrollment
- •Active malignancy other than lung cancer
- •Radiation therapy to sites other than whole brain within 14 days prior to enrollment
- •History of gross hemoptysis within 3 months prior to enrollment
- •Known hypersensitivity to any of the components of cytotoxic chemotherapy combinations, bevacizumab, or tyrosine kinase inhibitors
- •Inadequately controlled hypertension
- •Unstable angina or New York Heart Association Grade II or greater CHF
- •Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to enrollment
- •History of myocardial infarction within 6 months prior to enrollment
- •History of stroke within 6 months prior to enrollment
- •Symptomatic peripheral vascular disease within 6 months prior to enrollment
- •Evidence of bleeding diathesis or coagulopathy
- •Serious, non-healing wound, ulcer, or bone fracture
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment; anticipation of need for major surgical procedure during the course of the study
- •Current, recent, or planned participation in an experimental drug study other than this Genentech-sponsored bevacizumab/erlotinib study
- •Progressive neurologic symptoms in subjects with a history of brain metastases
- •History of significant vascular disease (e.g., aortic aneurysm)
研究组 & 干预措施
1
Experimental
干预措施: bevacizumab (Drug)
1
Experimental
干预措施: erlotinib HCl (Drug)
2
Placebo Comparator
干预措施: bevacizumab (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: Approximately 3 years
PFS was defined as the length of time from randomization until documented disease progression or death from any cause, whichever occurred earlier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Data presented until cut-off date 18 July 2008.
次要结局
- Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Chemotherapy Phase(Approximately 3 years)
- Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Post-Chemotherapy Phase(Approximately 3 years)
- Number of Participants With Any Adverse Events During Post-Chemotherapy Phase(Approximately 3.5 years)
- Incidence of Study Treatment Discontinuation for Reasons Other Than Disease Progression in Chemotherapy Phase(Approximately 3 years)
- Incidence of Study Treatment Discontinuation(Approximately 3 years)
- Overall Survival(Approximately 3.5 years)
研究者
研究点 (241)
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