Phase 3, Randomized, Open-label Study Of The Efficacy And Safety Of Pf-02341066 Versus Standard Of Care Chemotherapy (Pemetrexed Or Docetaxel) In Patients With Advanced Non-small Cell Lung Cancer (Nsclc) Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 347
- 试验地点
- 244
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug.
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
- •histologically or cytologically proven diagnosis of non-small cell lung cancer
- •positive for the ALK fusion gene (test provided by a central laboratory)
- •must have had disease progression after only one prior chemotherapy and that regimen but must have included one platinum drug
- •tumors must be measurable
排除标准
- •prior treatment with PF-02341066
- •current treatment in another clinical trial
研究组 & 干预措施
PF-02341066
干预措施: PF-02341066 (Drug)
Pemetrexed or Docetaxel
Investigator selection of either pemetrexed or docetaxel as the active comparator
干预措施: Pemetrexed (Drug)
Pemetrexed or Docetaxel
Investigator selection of either pemetrexed or docetaxel as the active comparator
干预措施: Docetaxel (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Randomization until progressive disease (PD) or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)
PFS: Time in months from randomization to first documentation of objective disease progression as determined by independent radiology review or to death due to any cause, whichever occurred first. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 30.4. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria version 1.1 (RECIST v1.1), as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
次要结局
- Overall Survival (OS)(Randomization until death (up to 4.5 years))
- Overall Survival Probability at Months 6 and 12(Month 6, 12)
- Duration of Response (DR)(Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks))
- Percentage of Participants With Disease Control at Week 6(Week 6)
- Time to Tumor Response (TTR)(Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks))
- European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)(Baseline, Day (D) 1 of each cycle (C) until disease progression, end of treatment (EOT, up to 112 weeks))
- Percentage of Participants With Disease Control at Week 12(Week 12)
- European Quality of Life - 5 Dimensional (EQ-5D) Visual Analog Scale (VAS)(Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks))
- Plasma Concentration of Crizotinib(Pre-dose on Cycle 1 Day 1, Cycle 1 Day 15, and Day 1 of Cycles 2, 3, 5)
- Plasma Concentration of Soluble c-Met Ectodomain and Hepatocyte Growth Factor Scatter Proteins(Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 2, end of treatment (up to 112 weeks))
- European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Supplement Module for Lung Cancer (EORTC QLQ-LC13)(Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks))
- Percentage of Participants With Objective Response (OR)(Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks))
- Number of Participants With Categorical Maximum QTcF for Crizotinib(Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 1, 2)
- Time to Deterioration (TTD) in Participant Reported Pain, Dyspnea, and Cough(Baseline up to end of treatment (up to 112 weeks))