NCT00321815已完成2 期
A Randomized Phase 2 Trial Of Erlotinib With Or Without PF-3512676 For The Treatment Of Patients With Advanced EGFR-Positive Non-Small Cell Lung Cancer After Failure Of At Least One Prior Chemotherapy Regimen
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Progression-Free Survival
研究概览
简要总结
To assess the efficacy and safety of PF-3512676 administered in combination with erlotinib in patients with advanced EGFR-positive non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
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
- •Advanced, EGFR-positive NSCLC
- •ECOG Performance Status 0, 1 or 2
- •Measurable disease
排除标准
- •Known CNS metastasis
- •Pre-existing autoimmune or antibody mediated disease
研究组 & 干预措施
A
Experimental
Standard of Care chemotherapy plus experimental intervention (PF-3512676)
干预措施: PF-3512676 + Erlotinib (Drug)
B
Active Comparator
Standard of Care chemotherapy
干预措施: Erlotinib (Drug)
结局指标
主要结局
Progression-Free Survival
时间窗: 50Events
次要结局
- Overall Safety Profile(28 days post treatment)
- Time to Tumor Progression(End of treatment)
- Overall Objective Response Rate(Time of disease progression)
- Duration of Response(Time of disease progression)
- Overall Survival(Time of death)
研究者
研究点 (1)
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