A Single-arm, Open-label, Multicenter Feasibility Trial of Bevacizumab Given in Combination With Concomitant Chemoradiation (Cisplatin and Vinorelbine) in Locally Advanced Unresectable Non-squamous, Non-small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 主要终点
- Safety: Adverse events; clinical laboratory parameters; physical exam including vital signs; performance status.
研究概览
简要总结
This single arm study will assess the feasibility of use, safety and tolerability of Avastin(bevacizumab) in combination with chemoradiation therapy in patients with locally advanced unresectable non-squamous non-small cell lung cancer.An initial cohort of patients will receive Avastin 7.5mg/kg iv every 3 weeks, in combination with concurrent thoracic radiation for 6.6 weeks and chemotherapy (cisplatin 75 mg/m2 iv and vinorelbine 15mg/m2 iv administered according to a standard treatment protocol). If no dose-limiting toxicities are observed, a second cohort of patients will receive Avastin at a dose of 15mg/kg iv every 3 weeks, in combination with a similar treatment regimen to that of the first cohort. After 5 cycles of combination treatment, Avastin monotherapy will be administered for a further 4 cycles. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •patients >=18 years with locoregional advanced unresectable non-squamous NSCLC;
- •ECOG performance status of 0 or 1;
- •no prior thoracic head and neck irradiation or surgical resection for current lung cancer.
排除标准
- •mixed, non-small cell and small cell tumors;
- •mixed adeno-squamous carcinomas with a predominant squamous component;
- •evidence of tumor invasion or encasement of major vessels;
- •history of grade >=2 hemoptysis;
- •presence of cavitations in lung lesions at baseline.
研究组 & 干预措施
1
干预措施: bevacizumab [Avastin] (Drug)
1
干预措施: cisplatin (Drug)
1
干预措施: vinorelbine (Drug)
结局指标
主要结局
Safety: Adverse events; clinical laboratory parameters; physical exam including vital signs; performance status.
时间窗: Throughout study
次要结局
- Tumor response(Week 13 and Week 22)