A Phase II Single-arm Trial of BIBW 2992 in EGFR FISH Positive Non-small Cell Lung Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 13
- 主要终点
- Percentage of Participants With Best Objective Response
研究概览
简要总结
The primary objective of this open-label, single arm Phase II trial is to explore the efficacy of BIBW 2992 defined by the objective response rate (CR, PR) as determined by the RECIST criteria in patients with EGFR FISH positive advanced NSCLC Stage IIIB or IV, selected according to the following scheme:
- Forty (40) 1st line patients
- Thirty (30) 2nd line patients Patients entered into the trial will be treated and followed until death or lost to follow-up. Additional information will be obtained on the safety profile and PK analysis of BIBW 2992.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BIBW 2992
BIBW 2992 in EGFR FISH positive NSCLC patients
干预措施: BiBW 2992 (Drug)
结局指标
主要结局
Percentage of Participants With Best Objective Response
时间窗: Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12.
Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0.
次要结局
- Duration of Confirmed Objective Response (OR)(Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12.)
- Duration of Confirmed Disease Control(Every 8 weeks until last response assessment 28NOV12)
- Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 15 (Cpre,ss,15)(Day 15)
- Number of Participants With Objective Response (OR) Categorized by Time(Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12.)
- Percentage of Participants With Disease Control (DC)(Every 8 weeks until last response assessment 28NOV12)
- Overall Survival (OS) Time(Baseline until last vital status assessment 17JUN13)
- Progression Free Survival (PFS) Time(Every 8 weeks until last response assessment 28NOV12)
- Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder(First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks)
- Assessment of Eastern Cooperative Oncology Group (ECOG) Performance Status(End Of Treatment, up until 190 weeks)
- Number of Participants With Clinical Relevant Findings in Laboratory Safety Parameters, Vital Signs and Left Ventricular Ejection Fraction(First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks)