Open-label Study of Bevacizumab Maintenance Therapy (AVASTIN®) With or Without Pemetrexed After First-line Chemotherapy With Bevacizumab-cisplatin-pemetrexed in Patients With Advanced, Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 376
- 主要终点
- Progression Free Survival During Maintenance Treatment Phase
研究概览
简要总结
This open-label study will assess the efficacy and safety of Avastin with or without pemetrexed as maintenance therapy in patients with advanced, metastatic or recurrent non-small cell lung cancer. In Part 1, patients will receive 4 cycles of treatment with Avastin (7.5mg/kg iv) plus cisplatin (75mg/m2 iv) plus pemetrexed (500mg/m2 iv) on day 1 of each 3-week cycle. In Part 2, patients responding to treatment will be randomized to receive further treatment cycles of Avastin (7.5mg/kg iv every 3 weeks) with or without pemetrexed (500mg/m2 iv every 3 weeks). Anticipated time on study treatment is until disease progression. Target sample size is <500 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults >/=18 years of age
- •inoperable, locally advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC)
- •at least 1 measurable lesion meeting RECIST criteria
- •ECOG performance status 0-2
- •adequate hematological, liver and renal function
排除标准
- •prior chemotherapy or treatment with another systemic anti-cancer agent
- •malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer or DCIS
- •evidence of tumor invading major blood vessels
- •current or recent use of aspirin (>325mg/day) or full-dose anticoagulants or thrombolytic agents for therapeutic purposes
- •history of haemoptysis >/=grade 2
- •clinically significant cardiovascular disease
研究组 & 干预措施
Part 1
干预措施: bevacizumab [Avastin] (Drug)
Part 1
干预措施: cisplatin (Drug)
Part 1
干预措施: pemetrexed (Drug)
Part 2A
干预措施: bevacizumab [Avastin] (Drug)
Part 2B
干预措施: bevacizumab [Avastin] (Drug)
Part 2B
干预措施: pemetrexed (Drug)
结局指标
主要结局
Progression Free Survival During Maintenance Treatment Phase
时间窗: Up to 21 months
Progression free survival (PFS) is defined as the time from randomization to the date of documented disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) , or the date of occurrence of a second primary cancer, or date of death from any cause, whichever comes first. Progression is defined using (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, the appearance of new lesions and increase of at least 5 mm in the sum of diameters of target lesions.Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.
次要结局
- Overall Survival During Maintenance Treatment Phase(Up to 21 months)
- Best Overall Response Rate During Maintenance Treatment Phase(Up to 21 months)
- Duration of Response During Maintenance Treatment Phase(Up to 21 months)
- Duration of Disease Control During Maintenance Treatment Phase(Up to 21 months)
- Incidence of Adverse Events and Serious Adverse Event(Up to 21 months)
- Number of Participants With Marked Laboratory Abnormalities(Up to 21 months)
- Quality of Life(Up to 21 months)