A PHASE 2, OPEN-LABEL TRIAL OF DACOMITINIB (PF-00299804) IN SELECTED PATIENTS WITH ADVANCED ADENOCARCINOMA OF THE LUNG
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 119
- 试验地点
- 36
- 主要终点
- Progression-Free Survival (PFS) at Month 4: Cohort A
研究概览
简要总结
This study will explore the safety and efficacy of the oral PanHER inhibitor PF-00299804 in patients with adenocarcinoma of the lung who are either non-smokers (<100 cigarette, cigar or pipe lifetime) or former light smokers ( less than 10 pack-years and stopped at least 15 years) or have known EGFR activating mutation; or patients with HER 2 amplification or mutation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 adenocarcinoma of lung, measurable disease
- •Non-smoker, or former light (less than 10 pack years and stopped at least 15 years); OR
- •patients with known EGFR activating mutation regardless of smoking status
- •ECOG(Eastern Cooperative Oncology Group) 0-
- •Cohort B (select sites only): patients with HER2 amplified or HER2 mutation-positive NSCLC; may have had prior therapy
排除标准
- •Active brain metastases
- •Prior systemic therapy for advanced disease in Cohort A only. Cohort B can have had any number of prior lines of systemic therapy.
- •known EGFR wild type NSCLC
研究组 & 干预措施
Cohort A
Dacomitinib (PF-00299804) in patients with EGFR mutated NSCLC or clinical characteristics defined above to enhance for EGFR mutated NSCLC
干预措施: Dacomitinib (PF-00299804) (Drug)
Cohort B
Dacomitinib in patients with HER2 mutated or amplified NSCLC
干预措施: Dacomitinib (PF-00299804) (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) at Month 4: Cohort A
时间窗: Baseline up to Month 4
PFS at Month 4 was defined as percentage of participants who were alive and event free (event defined as progressive disease \[PD\] or death due to any cause, whichever occurs first) at 4 months after the first dose of study treatment. Documentation of progression was based on Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) criteria. PD = greater than or equal to (\>=) 20 percent (%) increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the start of treatment, or the appearance of 1 or more new lesions, or unequivocal progression in non-target lesions.
次要结局
- Best Overall Response (BOR)(Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.)
- European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score(Baseline (Cycle [C]1 Day 1), up to C75)
- Progression-Free Survival (PFS)(Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.)
- Duration of Response (DR)(Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.)
- European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Score(Baseline (C1D1) up to C75)
- Progression-Free Survival (PFS) at Month 4: Cohort B(Baseline up to Month 4)
- Overall Survival (OS)(Randomization until death or last date known to be alive.)
- Trough Plasma Concentrations (Ctrough) of Dacomitinib(Predose on C1D14, C2D1, C3D1, C4D1)