Open-label Study of Bevacizumab (AVASTIN®) in Combination With Platinum-containing Chemotherapy as First-line Treatment of Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2,252
- 主要终点
- Number of Participants With Adverse Events of Special Interest
研究概览
简要总结
This single arm study will assess the safety and efficacy of Avastin combined with platinum-containing chemotherapy regimens in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC). Avastin will be given as first-line treatment in combination with platinum-based chemotherapy or in combination with any standard of care NSCLC first-line chemotherapy used in line with the licensed national prescribing information. Eligible patients will receive Avastin (15mg/kg iv on day 1 of each 3 week cycle) concomitantly with chemotherapy. Avastin treatment will continue after completion of chemotherapy cycles until disease progression, and the target sample size is 500+ individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •adult patients, >=18 years of age;
- •histologically or cytologically documented inoperable, locally advanced ( stage III), metastatic (stage IV) or recurrent NSCLC other than squamous cell (tumors of mixed histology should be categorized by the predominant cell type);
- •ECOG PS status 0-2;
- •life expectancy >= 12weeks;
- •adequate renal, liver and hematological function.
排除标准
- •mixed, non-small and small cell tumors, or mixed adenosquamous carcinomas with a predominant squamous component;
- •hemoptysis (>=1/2 teaspoon of bright red blood) in previous 3 months;
- •evidence of tumor invading major blood vessels on imaging;
- •evidence of CNS metastases, even if previously treated.
- •major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment, or anticipation of need for major surgery during study treatment;
- •prior chemotherapy for stage IIIb/IV disease.
研究组 & 干预措施
Bevacizumab + Chemotherapy
Participants with advanced or recurrent NSCLC will be administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator's choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab will be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy.
干预措施: Platinum-based chemotherapy (Drug)
Bevacizumab + Chemotherapy
Participants with advanced or recurrent NSCLC will be administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator's choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab will be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy.
干预措施: Bevacizumab [Avastin] (Drug)
结局指标
主要结局
Number of Participants With Adverse Events of Special Interest
时间窗: Up to 3 years
Participants with adverse events (AEs) of special interest (hypertension, proteinuria, wound healing complications, gastrointestinal perforation, arterial and venous thromboembolic events, hemoptysis, Central Nervous System (CNS) bleeding, other hemorrhage events and congestive heart failure) were reported.
Number of Participants With Serious Adverse Events Related to Bevacizumab
时间窗: Up to 3 years
Participants with serious adverse events (SAEs) related to bevacizumab were reported for the duration of the study.
次要结局
- Duration of Overall Survival(Up to 3 years)
- Time to Disease Progression(Up to 3 years)
- Number of Participants With Central Nervous System Bleeding(Up to 3 years)