Available - Avastin in Addition to Platinum-based Chemotherapy is Indicated for First-lime Treatment of Patients With Locally Advanced, Metastatic or Recurrent Non-small 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
- 996
- 主要终点
- Percentage of Participants With Adverse Drug Reactions (ADRs), Toxicities, Avastin-Related ADRs, and Serious ADRs
研究概览
简要总结
The purpose of this non-interventional study is the collection and documentation of data on safety and efficacy of intravenous (IV) bevacizumab (Avastin) in addition to platinum-based chemotherapy for first-line treatment in participants with unresectable advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology with focus on adenocarcinoma and elderly patients in daily routine.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •Age greater than or equal to (>=) 18 years
- •Histologically confirmed predominantly non-squamous NSCLC that is unresectably advanced, metastatic or recurrent (with or without adenocarcinoma)
- •No contraindications to Avastin® according to the current Summary of Product Characteristics (SmPC) for Avastin®
- •Therapeutic decision for Avastin® as first line treatment in combination with platinum-based chemotherapy was taken individually and independent of the non-interventional trial.
排除标准
- 未提供
研究组 & 干预措施
Bevacizumab
Patients will receive six 3-weeks cycle of IV bevacizumab along with platinum-based chemotherapy, followed by maintenance therapy of bevacizumab until progression (approximately 7 months).
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Drug Reactions (ADRs), Toxicities, Avastin-Related ADRs, and Serious ADRs
时间窗: Up to 74 months
ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. Serious ADRs were defined as any untoward medical occurrence or effect that at any dose resulted in death or life-threatening conditions or required hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect or medically important condition. Toxicity was defined as an adverse event that had an attribution (the relationship to investigational agent) of possible, probable or definite. Avastin-related ADRs (an adverse event with a possible relationship or a relationship to the treatment with AVASTIN) were due to Avastin. ADRs includes serious as well as non-serious ADRs.
次要结局
- Percentage of Participants Who Withdrew or Modified Treatment(Up to 74 months)
- Percentage of Participants With Best Tumor Response Over Time(Up to 74 months)
- Number of Cycles of Systemic Therapy(Up to 74 months)
- Overall Survival(Up to 74 months)
- Percentage of Participants With Eastern Cooperative Group(ECOG) Performance Status Grades(Up to 74 months)
- Percentage of Participants With Disease Control(Up to 74 months)
- Progression Free Survival (PFS)(Up to 74 months)
- Percentage of Participants Who Died(Up to 74 months)