NCT02093000已完成不适用
A Multicenter, Prospective, Non-interventional Study of Maintenance Avastin® (Bevacizumab) Following Induction Treatment With Platinum Doublet Plus Avastin® in Patients With Advanced Lung Adenocarcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 16
- 主要终点
- Progression-Free Survival (PFS), Defined as Time From First Dose of Maintenance Avastin Treatment Until Disease progression or death from any cause
研究概览
简要总结
This prospective, open-label, single arm, non-interventional study will investigate the effectiveness of bevacizumab monotherapy in participants with lung adenocarcinoma who previously received 4 to 6 cycles of induction platinum doublet plus bevacizumab.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Participant who previously received 4 to 6 cycles of induction platinum doublet plus bevacizumab
- •Participant who received only 1 cycle of bevacizumab maintenance treatment
- •Meet summary of product characteristics guidelines
排除标准
- •Participant who received the first cycle of maintenance bevacizumab more than 4 weeks after the postinduction tumor assessment
- •Pregnant or breast-feeding
研究组 & 干预措施
Bevacizumab
Participants who have received the induction phase of 4-6 cycles of bevacizumab plus platinum doublet chemotherapy will be treated with bevacizumab as maintenance treatment, according to approved label and local reimbursement.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Progression-Free Survival (PFS), Defined as Time From First Dose of Maintenance Avastin Treatment Until Disease progression or death from any cause
时间窗: Baseline up to 40 months
次要结局
- Percentage of participants with adverse events(Baseline up to 40 months)
- Percentage of participants by best overall response(Baseline up to 40 months)
- PFS, defined as time from first dose of induction Avastin treatment until disease progression or death from any cause(Baseline up to 40 months)
- 1-year overall survival defined as time from first dose of induction Avastin treatment until death from any cause(12 months)
研究者
研究点 (16)
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