A Phase II Trial of Bevacizumab in Combination With First- or Second-Line Therapy in Subjects With Treated Brain Metastases Due to Non-Squamous Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 115
- 主要终点
- Percentage of Participants With Symptomatic National Cancer Institute's Common Terminology Criteria for Adverse Events v3.0 (NCI CTCAE) Grade ≥2 Central Nervous System (CNS) Hemorrhage
研究概览
简要总结
This was an open-label, multicenter, single-arm, Phase II trial of bevacizumab combined with first- or second-line therapy in patients with metastatic non-squamous non-small cell lung cancer (NSCLC) with previously treated central nervous system (CNS) metastases. A total of 115 patients enrolled in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Histologically or cytologically confirmed NSCLC except for squamous cell carcinoma
- •Treated brain metastases without evidence of progression or hemorrhage after treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period
- •Appropriateness for first- or second-line systemic therapy for advanced NSCLC
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Age ≥ 18 years
- •For women of childbearing potential and sexually active males, use of an accepted and effective method of contraception (e.g., hormonal or barrier methods, abstinence) prior to study entry and for the duration of the study
排除标准
- •Brain biopsy/neurosurgical procedure performed within 3 months prior to Day 1
- •Progressive neurologic symptoms
- •Active malignancy other than lung cancer
- •Current, recent, or planned participation in an experimental drug study
- •Prior treatment with an investigational or marketed agent that acts by anti-angiogenesis mechanisms
- •Gross hemoptysis within 3 months prior to Day 1
- •Inadequately controlled hypertension
- •Unstable angina or New York Heart Association Grade II or greater congestive heart failure (CHF)
- •Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1
- •Myocardial infarction within 6 months prior to Day 1
- •Stroke within 6 months prior to Day 1
- •Active symptomatic peripheral vascular disease within 6 months prior to Day 1
- •History of significant vascular disease
- •Evidence of bleeding diathesis or coagulopathy
- •Known hypersensitivity to any components of bevacizumab
- •Inadequate organ function
- •Serious non-healing wound, ulcer, or bone fracture
- •Urine protein/creatinine (UPC) ratio of ≥ 1.0
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, or anticipation of need for major surgical procedure during the course of the study
- •Pregnancy or lactation
- •Known evidence of disseminated intravascular coagulation (DIC)
- •Active infection or fever > 38.5°C within 3 days prior to Day 1
- •Any other medical condition (including mental illness or substance abuse) deemed by the clinician to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
研究组 & 干预措施
bevacizumab
干预措施: bevacizumab (Drug)
bevacizumab
干预措施: First-Line Chemotherapy Agents (Drug)
bevacizumab
干预措施: Second-Line Chemotherapy Agents (Drug)
结局指标
主要结局
Percentage of Participants With Symptomatic National Cancer Institute's Common Terminology Criteria for Adverse Events v3.0 (NCI CTCAE) Grade ≥2 Central Nervous System (CNS) Hemorrhage
时间窗: From the first administration of bevacizumab until 60 days after discontinuation of bevacizumab treatment was reported (up to 2 years)
The percentage of participants with symptomatic NCI CTCAE Grade ≥ 2 CNS hemorrhage, defined as the presence of clinical symptoms determined by the investigator to be directly referable to a Grade ≥ 2 CNS hemorrhage. Grade 1: Asymptomatic, radiographic findings only Grade 2: Medical intervention indicated Grade 3: Ventriculostomy, intracranial pressure (ICP) monitoring, intraventricular thrombolysis, or operative intervention indicated Grade 4: Life-threatening consequences; neurologic deficit or disability Grade 5: Death
次要结局
- Overall Survival (OS) in First-line Setting(Time from enrollment to death from any cause (up to 2 years))
- Number of Participants With Overall Survival (OS) in First-line Setting [1-Year or More Survival](Time from enrollment to death from any cause (up to 2 years))
- OS in First-line and Second-line Settings(Time from enrollment to death from any cause (up to 2 years))
- Number of Participants With OS in First-line and Second-line Settings [1-Year or More Survival](Time from enrollment to death from any cause (up to 2 years))
- Number of Participants With Selected Adverse Events(From start of bevacizumab treatment to 60 days following discontinuation of bevacizumab (up to 2 years))