A Randomized, Open-label, Multi-center Trial Investigating Zalutumumab, a Human Monoclonal Anti-EGF Receptor Antibody, in Combination With Chemo-Radiation in Stage IIIA-IIIB Non Small Cell Lung Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Genmab
- 入组人数
- 13
- 试验地点
- 7
- 主要终点
- Progression Free Survival Verified by Imaging Techniques.
研究概览
简要总结
The purpose of the study is to investigate if treatment with zalutumumab in combination with chemotherapy and radiotherapy (chemo-radiation) will lead to a prolonged life in patients with lung cancer compared to patients treated with chemo-radiation alone.
详细描述
Originally the study was planned as Part 1A, Part 1B and Part 2. Part 1A was one arm with zalatumumab fixed dose 8 mg/kg. Part 1B was planned as zalutumumab dose-titration and Part 2 adding a comparator. The trial was prematurely closed for enrolment when patients had only been enrolled in Part 1A due to published results showing increased toxicity from induction chemotherapy without any survival benefit.
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
- •NSCLC stage IIIA-IIIB
- •Performance status 0 or 1 (Zubrod or WHO Scale)
排除标准
- •Evidence of metastases either in a separate lobe of the lung, or extra thoracic
- •Patients with high risk of radiation pneumonitis and or compromised lung function
- •Estimated life expectancy of less than 3 months
- •Prior chemotherapy for lung cancer
- •Prior radiotherapy to the chest
- •Prior surgery with curative intent for lung cancer
研究组 & 干预措施
Zalutumumab 8 mg/kg
干预措施: Zalutumumab (Biological)
Zalutumumab 8 mg/kg
干预措施: Induction chemotherapy (Drug)
Zalutumumab 8 mg/kg
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Progression Free Survival Verified by Imaging Techniques.
时间窗: Until disease progression
Disease progression was planned to be confirmed using RECIST criteria J Natl Cancer Inst 2000;92:205-16
次要结局
- Adverse Events(Up to 3 months)