NCT00112346已完成2 期
A Randomized Multicenter Phase II Study of Gemcitabine/Platinum/Cetuximab Versus Gemcitabine/Platinum as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- tumor response per treatment arm
研究概览
简要总结
The primary purpose of this study is to estimate the number of patients with non-small cell lung cancer whose tumor responds to the treatments given in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Must have advanced or metastatic non-small cell lung cancer that has not been previously treated with any chemotherapy.
- •Must not have received cetuximab or any medications that target the same pathway as cetuximab (such as Iressa or Tarceva).
- •Must not have had hypersensitivity or severe allergic reactions to any monoclonal antibodies and must not have severe restrictive or interstitial lung disease.
- •Must be able to carry out work of light or sedentary nature (e.g. light house work, office work).
- •It must be at least 4 weeks since last major surgery or prior treatment with an investigational product and at least 12 weeks from any radiation therapy to the chest.
排除标准
- •Women who are pregnant or breastfeeding.
- •Women with a positive pregnancy test on enrollment or prior to study drug administration.
- •Any concurrent malignancy (subjects with a previous malignancy but without evidence of disease for 5 years will be allowed to enter the trial).
- •Symptomatic or uncontrolled metastases in the central nervous system (CNS).
- •Peripheral neuropathy.
- •Inadequate hematologic function defined by an absolute neutrophil count (ANC) <1,500/mm^3, a platelet count <100,000/mm^3, or a hemoglobin level < 9g/dL.
- •Inadequate liver function.
- •Inadequate kidney function.
研究组 & 干预措施
A
Active Comparator
干预措施: Cetuximab + platinum + gemcitabine (Drug)
B
Active Comparator
干预措施: Platinum + Gemcitabine (Drug)
结局指标
主要结局
tumor response per treatment arm
次要结局
- disease control, symptom response, symptomatic progression, & progression free survival.
研究者
研究点 (1)
Loading locations...
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