NCT00092924已完成2 期
A Phase 2, Multi-Center, Open-Label Study to Evaluate the Efficacy, Safety, and Tolerability of TRM-1 (Fully Human Monoclonal Antibody To TRAIL-R1) in Subjects With Relapsed or Refractory Non-Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 10
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of TRM-1 in subjects with relapsed or refractory non-small cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Primary Inclusion Criteria:
- •Relapsed or refractory histologically or cytologically confirmed Stage IIIB, IV, or recurrent NSCLC
- •Previously treated and failed to respond to standard therapy or progressed after standard therapy
- •18 years of age or older
排除标准
- •Received a non-FDA approved investigational agent within the last 4 weeks.
- •Previous cancer therapies (chemotherapy, hormonal therapy, monoclonal antibodies or radiation therapy) within the last 3 weeks, 8 weeks for fully human or humanized monoclonal antibodies
- •Infection requiring antibiotics or hospitalization within the last 2 weeks
- •HIV, Hepatitis-B, Hepatitis-C
- •Pregnant or breast-feeding women
- •Major surgery within the last 4 weeks
- •History of other cancers within the past 5 years
研究者
研究点 (10)
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