Phase I/II Study With the Combination of Dacomitinib and PD-0325901 in Metastatic KRAS Mutation Positive Non-small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 3
- 主要终点
- Incidence rate of dose-limiting toxicities
研究概览
简要总结
This is a phase I/II multi-center open-label proof of concept study, consisting of two parts. Part A of this study is designed to identify the recommended phase 2 dose (RP2D) of the combination regimen of dacomitinib plus PD-0325901 in patients with advanced KRAS mutant (KRASm) non-small cell lung cancer (NSCLC). Part B is designed to perform a randomized comparison of the combination of dacomitinib and PD-0325901 versus standard of care therapy in patients with advanced KRASm NSCLC. It is hypothesized that with this combination strategy the progression free survival of patients with KRASm NSCLC will be doubled.
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
- •Histological or cytological proof of advanced non-small cell lung cancer
- •Written documentation of KRAS (exon 2, 3 or 4) mutation
- •At least 18 years of age or older
- •Able and willing to give written informed consent
- •WHO performance status of 0 or 1
排除标准
- •Symptomatic or untreated leptomeningeal disease
- •Symptomatic brain metastasis
- •Impairment of gastrointestinal function
- •Uncontrolled infectious disease
- •Left ventricular ejection fraction < 50%
- •Retinal degenerative disease or with history of uveitis, retinal vein occlusion or retinal detachment
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Dacomitinib + PD-0325901
Dacomitinib: oral tablets PD-0325901: oral capsules
干预措施: Dacomitinib (Drug)
Dacomitinib + PD-0325901
Dacomitinib: oral tablets PD-0325901: oral capsules
干预措施: PD-0325901 (Drug)
Dacomitinib + PD-0325901
Dacomitinib: oral tablets PD-0325901: oral capsules
干预措施: Docetaxel (Drug)
结局指标
主要结局
Incidence rate of dose-limiting toxicities
时间窗: 1.5 years
Progression free survival
时间窗: 2.5 years
次要结局
- Duration of response(1.5 years)
- Time to response(2.5 years)
- Plasma concentration(2.5 years)
- Overall response rate(2.5 years)
- Incidence and severity of adverse events(2.5 years)
- Overall survival(3 years)