A Multi-Center Observational Survey of the Efficacy and Safety of Avastin in Addition to Platimun-Based Chemotherapy for First-Line Treatment of Patients With Locally Advanced, Metastatic or Recurrent Non-Small Cell Lung Cancer Other Than Predominantly Squamous Cell Histology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 33
- 主要终点
- Time to Disease Progression
研究概览
简要总结
The purpose of this study is to examine the efficacy of Bevacizumab in addition to platinum-based chemotherapy for first-line treatment of participants with advanced stage (IIIB/IV) non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •In accordance with the SPC. Most important criteria:
- •Histology or cytology proven inoperable, locally advanced,metastatic or recurrent (stage IIIB/IV) NSCLC other than predominantly squamous cell histology
- •First-line treatment is indicated
- •No previous treatment with Bevacizumab
排除标准
- •In accordance with the SPC. Most important criteria:
- •Hypersensitivity to the active ingredient or to any of the excipients
- •Hypersensitivity to products derived from Chinese hamster ovary (CHO) cells or to other recombinant human or humanized antibodies
- •Pregnancy
- •Bevacizumab is contraindicated in the presence of untreated central nervous system metastases
研究组 & 干预措施
Bevacizumab
Participants with advanced (stage IIIB/IV) NSCLC other than predominantly squamous cell histology receiving Bevacizumab in accordance with the summary product characteristics (SPC) is observed.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Time to Disease Progression
时间窗: up to 45 months
Time to progression is the time elapsed from the date of enrollment to the first documented progression or to death of any cause. For participants who don't show progression or die until the end of treatment, the date of last contact is taken as the censoring time.
次要结局
- Best Tumor Response(Up to 45 months)
- Overall Survival(Up to 45 months)
- Number of Participants with Serious Adverse Events (SAEs) and Adverse Events (AEs)(Up to 45 months)