Randomized, Open Label, Phase 3 Clinical Study To Evaluate The Effect Of The Addition Of CP-751,871 To Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- Overall Survival
研究概览
简要总结
Gemcitabine and cisplatin given together is a standard treatment option for advanced lung cancer patients. The purpose of this study is to assess if the life span is longer in patients taking the investigational drug CP-751,871 in combination with gemcitabine and cisplatin compared to gemcitabine and cisplatin alone. Considering a 10% rate of drop-outs, 1,210 participants will be required in order to have an adequate sample size (1,100 evaluable patients) and power to detect a 30% prolongation of survival on the experimental arm.
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
- •Non-Small Cell Lung Cancer (NSCLC), advanced, chemotherapy-naive
- •Male or female > 18 years
- •Eastern Oncology Cooperative Group (ECOG) Performance Status (PS) 0 or 1
- •Adequate organ function
排除标准
- •Uncontrolled hypertension or diabetes;
- •Pregnant female;
- •Symptomatic Central Nervous System (CNS) metastasis, requirement for chronic corticosteroids.
研究组 & 干预措施
CP-751,871 + Gemcitabine + Cisplatin
investigational arm
干预措施: CP-751,871 (Drug)
CP-751,871 + Gemcitabine + Cisplatin
investigational arm
干预措施: Cisplatin (Drug)
CP-751,871 + Gemcitabine + Cisplatin
investigational arm
干预措施: Gemcitabine (Drug)
Gemcitabine + Cisplatin
standard of care
干预措施: Cisplatin (Drug)
Gemcitabine + Cisplatin
standard of care
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Overall Survival
时间窗: Dec 2012
次要结局
- Progression Free survival(Dec 2011)
- Objective Response(Dec 2011)
- Overall Safety Profile(Dec 2012)
- Pharmacokinetics(Dec 2012)
- Patient Reported Outcome(Dec 2012)
- Anti-drug Antibody(Dec 2012)
- Biomarker Analysis(Dec 2012)