A Randomized Phase 2 Trial Of Pf-00299804 Versus Erlotinib For The Treatment Of Advanced Non-small Cell Lung Cancer After Failure Of At Least One Prior Chemotherapy Regimen
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 188
- 试验地点
- 57
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This study will compare PF-00299804 given orally on continuous schedule to the approved drug, erlotinib, in patients whose non-small cell lung cancer has progressed after chemotherapy; patients will be randomized to receive one of these drugs, and followed for efficacy and tolerance of each.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •advanced measurable Non-Small Cell Lung Cancer (NSCLC);
- •progressed after 1-2 prior chemotherapy;
- •Eastern Cooperative Oncology Group (ECOG) 0-2;
- •tissue available for future KRAS/ EGFR testing
排除标准
- •prior Epidermal Growth Factor Receptor (EGFR) targeted therapy;
- •active or untreated Central Nervous System (CNS) metastases;
研究组 & 干预措施
B
干预措施: PF-00299804 (Drug)
A
干预措施: Erlotinib (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks
PFS: Time in weeks from randomization to date of objective disease progression or death due to any cause, whichever occurred first. PFS was calculated as (first event date or last known event-free date \[if the event date unavailable\] minus the date of randomization plus 1) divided by 7. Objective progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST), as at least 20 percent (%) increase in the sum of longest dimensions (LDs) of target lesions, taking as reference the smallest sum of LD recorded since the treatment started and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
次要结局
- Percentage of Participants With Objective Response(Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks)
- Categorical Summary of Overall Scale Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)(Baseline up to Cycle 44 (Week 188))
- Overall Survival (OS)(Baseline until end of treatment (15 August 2014); followed up every 8 weeks after discontinuation from study treatment.)
- Duration of Response (DR)(Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks)
- Dermatology Life Quality Index (DLQI)(Cycle (C) 1 Day (D) 1 (baseline), C1D10-14, D1 of subsequent cycles up to C44)
- Best Overall Response (BOR)(Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks)
- Categorical Summary of Overall Scale Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13)(Baseline up to Cycle 44 (Week 188))