A Double Blind Placebo Controlled Randomized Trial of PF-804 in Patients With Incurable Stage IIIB/IV Non-Small Cell Lung Cancer After Failure of Standard Therapy for Advanced or Metastatic Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 720
- 试验地点
- 88
- 主要终点
- Overall Survival
研究概览
简要总结
RATIONALE: PF-00299804 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether PF-00299804 is more effective than a placebo in treating patients with advanced non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying PF-00299804 to see how well it works compared with a placebo in treating patients with stage IIIB or stage IV non-small cell lung cancer that has not responded to standard therapy for advanced or metastatic cancer.
详细描述
OBJECTIVES:
Primary
- To compare overall survival in patients with incurable stage III or IV non-small cell lung cancer receiving PF-00299804 versus placebo after failure of standard therapy for advanced metastatic disease.
Secondary
- To compare overall survival in KRAS-WT patients between the two arms.
- To compare overall survival in EGFR-mutant patients between the two arms.
- To compare progression-free survival between arms.
- To compare objective response rates between arms.
- To estimate time to response and response duration in these patients.
- To evaluate the nature, severity, and frequency of toxicities between arms.
- To compare quality of life between arms.
- To determine the incremental cost-effectiveness and cost-utility ratios for PF-00299804.
- To correlate the expression of tumor and blood markers (at diagnosis) with outcomes and response.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
PF-00299804
Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: PF-00299804 (Drug)
Placebo
Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Survival
时间窗: 42 Months
Median and 95% confidence intervals
次要结局
- Overall Survival in EGFR-mutant Patients(42 Months)
- Overall Survival in KRAS-WT Patients(42 Months)
- Objective Response Rate(42 months)
- Number of Participants With Toxicity as Measured by NCI CTCAE Version 4.0(42 Months)
- Progression-free Survival(42 Months)