Bevacizumab, Pemetrexed and Cisplatin, or Erlotinib and Bevacizumab for Advanced Non-Squamous NSCLC Stratified by EGFR Mutation Status. A Multicenter Phase II Trial Including Biopsy at Progression (BIO-PRO Trial).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 22
- 主要终点
- Progression-free survival at 6 months in stratum wtEGFR cohort 1
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether bevacizumab given together with pemetrexed disodium and cisplatin is more effective than erlotinib hydrochloride given together with bevacizumab in treating patients with non-small cell lung cancer.
PURPOSE: This phase II trial is studying giving bevacizumab together with pemetrexed disodium and cisplatin to see how well it works compared with giving erlotinib hydrochloride together with bevacizumab in treating patients with stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- To demonstrate that tailored therapy, according to tumor histology and EGFR-mutation status, and the introduction of novel drug combinations in the frontline treatment of patients with stage IV non-squamous non-small cell lung cancer, is promising for further investigation.
Secondary
- To prospectively explore molecular markers of clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Stratum mut EGFR
- Bevacizumab 7.5 mg/kg i.v. every 3 weeks and
- Erlotinib 150 mg p.o. daily until progression.
干预措施: bevacizumab, erlotinib (Biological)
Stratum wtEGFR
Cohort 1:
Induction chemotherapy with
- Bevacizumab 7.5 mg/kg i.v. and
- Pemetrexed 500 mg/m2 i.v. and
- Cisplatin* 75 mg/m2 i.v. every 3 weeks for a maximum of 4 cycles or until progression.
Followed by maintenance therapy in patients without disease progression with
- Bevacizumab 7.5 mg/kg i.v. and
- Pemetrexed 500 mg/m2 i.v. every 3 weeks until progression.
Cohort 2:
Induction chemotherapy with
- Pemetrexed 500 mg/m2 i.v. and
- Cisplatin* 75 mg/m2 i.v. every 3 weeks for a maximum of 4 cycles or until progression.
Followed by maintenance therapy in patients without disease progression with
o Pemetrexed 500 mg/m2 i.v. every 3 weeks until progression.
干预措施: bevacizumab, pemetrexed, cisplatin (Drug)
结局指标
主要结局
Progression-free survival at 6 months in stratum wtEGFR cohort 1
时间窗: at 6 months
次要结局
- Best response (RECIST 1.1)(up to disease progression or start of new treatment)
- Adverse events (CTCAE v4.0)
- Molecular markers in tumor tissue and blood
- Progression-free survival(at 6 months)
- Overall survival(from registration until death)