An Open Label Study to Assess the Effect of First-line Treatment With Avastin in Combination With Docetaxel and Cisplatin on Progression-free Survival in Patients With Metastatic or Locally Advanced Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Progression-free Survival
研究概览
简要总结
This study assessed the efficacy and safety of Avastin in combination with docetaxel and cisplatin as first-line treatment of patients with metastatic or locally advanced non-small cell lung cancer. Patients received Avastin 15 mg/kg intravenously (IV), docetaxel 75 mg/m^2, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle for a maximum of 6 cycles.
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
- •Adult patients, ≥ 18 years of age.
- •Stage IIIb or IV non-small cell lung cancer.
- •Chemotherapy-naive.
排除标准
- •Previous treatment for non-small cell lung cancer.
- •Previous malignant tumor within last 5 years, except for basal cell skin cancer or preinvasive cervical cancer.
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to start of study.
- •Recent or current chronic treatment with aspirin (> 325 mg/day).
研究组 & 干预措施
Bevacizumab + cisplatin + docetaxel
Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
干预措施: Bevacizumab (Drug)
Bevacizumab + cisplatin + docetaxel
Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
干预措施: Cisplatin (Drug)
Bevacizumab + cisplatin + docetaxel
Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
干预措施: Docetaxel (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: Baseline to the end of the study (up to 4 years)
Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.
次要结局
- Percentage of Participants With an Objective Response(Baseline to the end of the study (up to 4 years))
- Duration of the Objective Response(Baseline to the end of the study (up to 4 years))
- Overall Survival(Baseline to the end of the study (up to 4 years))
- 1-year Survival(Baseline to 1 year)