NCT00063388已完成2 期
A Phase II Trial of Cetuximab (C225) as Therapy for Recurrent Non-Small Cell Lung Cancer (NSCLC)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 8
- 主要终点
- The primary objective of this study was to determine the tumor response rate for single-agent cetuximab in EGFR+ subjects.
研究概览
简要总结
Determine tumor response rate and time to disease progression, survival and safety in total populations.
详细描述
To determine the tumor response rate and time to disease progression, survival and safety in the EGFR-positive, EGFR-negative and total populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Subjects with recurrent or progressive NSCLC with either present or prior histologic confirmation or pathologic confirmation of NSCLC
- •Subjects receiving 1 or more prior chemotherapy regimens for the treatment of recurrent/metastatic disease, including at least 1 platinum-based combination
- •Unidimensionally measurable NSCLC
- •Subjects with tumor tissue available for EGFR assessment
- •ECOG performance status of 0 or 1
- •Subjects with asymptomatic brain metastasis were eligible; however, they must have completed radiotherapy/radiosurgery at least 3 weeks prior to enrollment and have been off steroids
排除标准
- •Women of childbearing potential who were unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study. Male subjects must also have agreed to use effective contraception
- •Women of childbearing potential using a prohibited contraceptive method
- •Women who were pregnant or breastfeeding
- •Women with a positive pregnancy test on enrollment or prior to study drug administration.
研究组 & 干预措施
1
Experimental
Cetuximab 400 mg/m2 intravenously (IV) (over 120 minutes) on Day 1 of Cycle 1. followed by weekly doses of 250 mg/m2 (over 60 minutes).
干预措施: Cetuximab (Biological)
结局指标
主要结局
The primary objective of this study was to determine the tumor response rate for single-agent cetuximab in EGFR+ subjects.
时间窗: Every 8 weeks
次要结局
- Determine the tumor response rate in the total population and in EGFR- subjects(Every 8 weeks)
- Time to disease progression in the EGFR+ and total populations.(Every 8 weeks)
- Survival in the EGFR+ and total populations.(Every 8 weeks)
- Safety in the EGFR+ and total populations.(Every 8 weeks)
研究者
研究点 (8)
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