EUCTR2010-022645-14-DE进行中（未招募）1 期
An open-label, randomized, Phase IIIb trial evaluating the efficacy and safety of standard of care +/- continuous bevacizumab treatment beyond progression of disease (PD) in patients with advanced non-squamous non-small cell lung cancer (NSCLC) after first (1st)-line treatment with bevacizumab plus a platinum doublet-containing chemotherapy - AvaA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Adult patients, age >/=18 years
- •- Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC)
- •- Documented progression of disease (locally recurrent or metastatic) per investigator assessment following first-line treatment 4-6 cycles of Avastin plus a platinum doublet-containing chemotherapy regimen and a minimum of 2 cycles of Avastin (monotherapy) maintenance treatment prior to first progression of disease
- •- No treatment interruption of Avastin treatment greater than 2 consecutive cycles (42 days) between the start of first-line treatment to start of Cycle 1 of second line treatment
- •- Randomization within 4 weeks of progression of disease
- •- At least one unidimensionally measurable lesion meeting RECIST criteria
- •- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 350
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •- Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
- •- History of pulmonary hemorrhage/hemoptysis greater than or equal to grade 2 within 3 months of randomization
- •- Major cardiac disease
研究者
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