A Phase III Randomized Trial of Gemcitabine/Oxaliplatin (GEMOX) Versus Carboplatin/Paclitaxel (CP) as First-Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 383
- 试验地点
- 59
- 主要终点
- To determine the relative efficacy, safety and clinical benefit of the GEMOX regimen compared to the standard combination regimen of CP as first-line treatment of Stage IIIB and IV NSCLC
研究概览
简要总结
The purpose of this study is to compare combination treatment of gemcitabine + oxaliplatin (GEMOX) with carboplatin + paclitaxel (CP) to determine if there is a difference in response and safety between the two drug combinations for the treatment of advanced non-small cell lung cancer (NSCLC).
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
- •Newly diagnosed, Stage IIIb or IV NSCLC, chemo or other systemic therapy naive
- •One (1) unidimensionally measurable lesion
- •ECOG Performance Status of 0 or 1, no peripheral neuropathy >Grade 1
- •Patients with clinically stable brain metastases on a stable dose of (or no longer requiring) dexamethasone at registration will be eligible. Patients who have received cranial radiation for brain metastases must be at least 4 weeks from last radiation treatment.
- •Recovery in full from any previous surgical procedure
- •No history of an acute cardiac or CNS event within 6 months of entry or current clinical evidence of congestive heart failure or non-stable coronary artery disease
排除标准
- •Hypersensitivity to any of the 4 study drugs
- •Concurrent immunotherapy or participation in any investigational drug study within 4 weeks
- •Serious uncontrolled intercurrent medical or psychiatric illness and organ allograft
- •History of other malignancy within the last 5 years (except for squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or superficial transitional cell carcinoma of the bladder)
- •Patient is a pregnant or lactating female
研究组 & 干预措施
Stratum 1
Subjects will be randomized in a 1:1 allocation to either GEMOX or CP after signed consents and baseline evaluations are completed, allowing for safe entry into the study. In order to avoid an unbalanced distribution by baseline characteristics, randomization will be stratified by one factor: disease stage (in a 1:4 proportion for Stage IIIb vs. Stage IV or relapsed disease). Randomization schedules will be produced for each stratum, and treatment allocation will be carried out centrally
干预措施: gemcitabine/Eloxatin (GEMOX) (Drug)
Stratum 2
Subjects will be randomized in a 1:1 allocation to either GEMOX or CP after signed consents and baseline evaluations are completed, allowing for safe entry into the study. In order to avoid an unbalanced distribution by baseline characteristics, randomization will be stratified by one factor: disease stage (in a 1:4 proportion for Stage IIIb vs. Stage IV or relapsed disease).
干预措施: carboplatin/paclitaxel (CP) (Drug)
结局指标
主要结局
To determine the relative efficacy, safety and clinical benefit of the GEMOX regimen compared to the standard combination regimen of CP as first-line treatment of Stage IIIB and IV NSCLC
时间窗: 22 months
次要结局
未报告次要终点