International, Randomized, Open-Label, Phase 3 Trial of Gemcitabine/Cisplatin Plus PF-3512676 Versus Gemcitabine/Cisplatin Alone as First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 839
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
To assess the efficacy and safety of PF-3512676 administered in combination with gemcitabine/cisplatin chemotherapy as first-line treatment in patients with locally advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) and to compare it to the efficacy and safety of gemcitabine/cisplatin alone.
详细描述
PF-3512676 dosing was stopped 20 June 2007 in response to DSMC recommendation to close the trial, citing lack of efficacy concerns as the primary reason with a safety issue (thrombocytopenia) also contributing to the decision. Subjects were allowed to complete standard of care treatment/survival follow-up. Data collection was completed on 25 June 2008.
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
- •Advanced Non-Small-Cell Lung Cancer (NSCLC) stage IIIB with pleural effusion or stage IV
- •No prior systemic treatment for Non-Small-Cell Lung Cancer (NSCLC) with chemotherapy, immunotherapy, biologic response modifiers or other investigational drugs
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1
排除标准
- •Small cell or carcinoid lung cancer
- •Known Central Nervous System (CNS) metastasis
- •Pre-existing auto-immune or antibody mediated diseases
研究组 & 干预措施
A
Standard of Care chemotherapy plus experimental intervention (PF-3512676)
干预措施: Cisplatin (Drug)
A
Standard of Care chemotherapy plus experimental intervention (PF-3512676)
干预措施: Gemcitabine (Drug)
A
Standard of Care chemotherapy plus experimental intervention (PF-3512676)
干预措施: PF-3512676 (Drug)
B
Standard of Care chemotherapy
干预措施: Cisplatin (Drug)
B
Standard of Care chemotherapy
干预措施: Gemcitabine + Cisplatin (Drug)
结局指标
主要结局
Overall Survival
时间窗: 656 Events
次要结局
- Duration of Response(Time of progressive disease)
- Patient Reported Outcomes(End of treatment)
- Overall Safety Profile(28 days post PF03512676 dosing)
- Time to Tumor Progression(Time of progressive disease)
- Progression Free Survival(Time of primary endpoint)
- Overall Objective Response(End of treatment)