Randomised Phase II Trial of Bevacizumab (AVASTIN®) in Combination With Gemcitabine or Attenuated Doses of Cisplatin and Gemcitabine as First-line Treatment of Elderly Patients With Advanced Non-squamous Non-small Cell Lung Cancer - EAGLES
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 86
- 主要终点
- Percentage of Participants Alive and Without Progressive Disease at Month 6
研究概览
简要总结
This 2 arm study will evaluate the efficacy and safety of Avastin + gemcitabine, and Avastin + gemcitabine + attenuated doses of cisplatin, as first line treatment in elderly patients with non-squamous non-small cell lung cancer. Patients will be randomised to receive either Avastin 7.5mg/kg iv on day 1 + gemcitabine 1200mg/m2 on days 1-8 of each 3 week cycle, or Avastin 7.5mg/kg iv on day 1 + cisplatin 60mg/m2 on day 1 + gemcitabine 1000mg/m2 on days 1-8 of each 3 week cycle. After 6 cycles of combination therapy, all patients will continue to receive Avastin monotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, >=70 years of age;
- •inoperable, locally advanced, metastatic non-squamous non-small cell lung cancer;
- •>=1 measurable lesion;
- •ECOG performance status 0-1.
排除标准
- •neoadjuvant/adjuvant chemotherapy within 6 months prior to enrollment;
- •radical radiotherapy with curative intent within 28 days prior to enrollment;
- •history of >=grade 2 hemoptysis in 3 months prior to enrollment;
- •evidence of CNS metastases;
- •current or recent (within 10 days of first dose of Avastin)use of aspirin (>325 mg/day)or full dose anticoagulants or thrombolytic agents for therapeutic purposes.
研究组 & 干预措施
1
干预措施: bevacizumab [Avastin] (Drug)
1
干预措施: gemcitabine (Drug)
2
干预措施: bevacizumab [Avastin] (Drug)
2
干预措施: cisplatin (Drug)
2
干预措施: gemcitabine (Drug)
结局指标
主要结局
Percentage of Participants Alive and Without Progressive Disease at Month 6
时间窗: Month 6
Disease progression was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (v 1.1). Disease progression was defined at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), progression of existing non-target lesions, or presence of new lesions.
次要结局
- Percentage of Participants With Disease Progression or Death(Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death, or consent withdrawal (up to 53 months))
- Percentage of Participants Alive at 12 Months After Randomization(1 year)
- Overall Survival (OS)(From randomization to death or end of the study (up to 53 months))
- Percentage of Participants With an Objective Response(Cycle 3 Day 15, Cycle 6 Day 15 and at Month 6)
- Percentage of Participants With Disease Control(Cycle 3 Day 15, Cycle 6 Day 15 and at Month 6)
- Percentage of Participants by Best Overall Response(Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death or consent withdrawal (up to 53 months))
- Progression Free Survival (PFS)(Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death, or consent withdrawal (up to 53 months))
- Duration of Response (DoR)(Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death or consent withdrawal (up to 53 months))
- Percentage of Participants Who Died(From randomization to death or end of the study (up to 53 months))