Randomized, Double-blinded, Placebo-controlled Phase II Study of Vandetanib (ZactimaTM) Maintenance for Locally Advanced or Metastatic Non-small-cell Lung Carcinoma (NSCLC) Following Platinum-doublet Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS) Rate at 3 Months
研究概览
简要总结
This study is multicenter, randomized, double-blinded, placebo-controlled Phase II study comparing vandetanib (300mg daily) plus best supportive care (BSC) to placebo plus BSC as maintenance treatment in patients with locally advanced or metastatic NSCLC, who have received and responded to prior platinum-doublet systemic chemotherapy. The primary objective of the study is to compare the Progression Free Survival (PFS) rate at 3 months in locally advanced or metastatic NSCLC patients with or without vandetanib maintenance.
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
- Double (Participant, Investigator)
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
- •Histologic or cytologic confirmation of locally advanced or metastatic NSCLC (IIIb-IV) at the time of original diagnosis.
- •Completion of 4 cycles of chemotherapy of gemcitabine (1,000 or 1250mg/m^2/day on day 1 and 8) and cisplatin (70-80mg/m^2/day on day 1) every 3 weeks and have shown response, Complete Response(CR), Partial Response (PR) or stable disease (SD) by RECIST.
- •WHO PS 0-1
- •No prior radiotherapy to chest, immunotherapy or biologic therapy
排除标准
- •Mixed small cell and non small-cell lung cancer history.
- •Prior treatment with EGFR TKIs or VEGFR TKIs (prior treatment with cetuximab [Erbitux] or bevacizumab [Avastin] is not permitted.)
- •Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol.
- •Radiation therapy within 4 weeks before the start of study therapy. Major surgery within 4 weeks, or incomplete healed surgical incision before starting study therapy.
研究组 & 干预措施
Vandetanib
干预措施: Vandetanib (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Progression-free Survival (PFS) Rate at 3 Months
时间窗: 12 weeks
Progression-free survival (PFS) rate at 3 months is defined as the number of patients without evidence of progression or death after 3 months from randomisation among the PFS-evaluable patients.
次要结局
- Overall Survival (OS)(Every 12 weeks unless the patient withdraws consent)
- Objective Response Rate (ORR)(Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.)
- Disease of Response (DOR)(Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.)
- Progression-free Survival (PFS)(Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.)