Phase I/II Study With Lapatinib Plus Trametinib in Patients With Metastatic KRAS Mutant 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
- 1
- 主要终点
- overall response rate
研究概览
简要总结
This is an open-label phase I/II multi-center study consisting of two parts. Part A of this study is designed to identify the recommended phase 2 dose (RP2D) of lapatinib combined with trametinib in patients with metastatic KRASm and PIK3CA wild-type (PIK3CAwt) non-small cell lung cancer (NSCLC). Part B is designed to perform a randomized comparison of the lapatinib-trametinib combination versus standard of care therapy in patients with metastatic KRASm/PIK3CAwt NSCLC.
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 metastatic NSCLC; for PART B: treated with first line therapy for metastatic disease only.
- •Written documentation of a known pathogenic KRAS (exon 2, 3 or 4) mutation and PIK3CA wild-type (exon 9 and 20)
- •Age ≥ 18 years
- •Able and willing to give written informed consent
- •WHO performance status of 0 or 1 (part A and B)
排除标准
- •Any treatment with investigational drugs within 30 days prior to receiving the first dose of investigational treatment.
- •History of another primary malignancy
- •Symptomatic or untreated leptomeningeal disease
- •Symptomatic brain metastasis
- •History of interstitial lung disease or pneumonitis
- •Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients
- •Retinal degenerative disease (hereditary retinal degeneration or age-related macular degeneration), or a history of uveitis, retinal vein occlusion, central serous retinopathy, or retinal detachment
- •Patients with left ventricular ejection fraction (LVEF) < 50%
研究组 & 干预措施
lapatinib + trametinib
lapatinib: oral tablets, once daily trametinib: oral tablets, once daily
干预措施: Lapatinib (Drug)
lapatinib + trametinib
lapatinib: oral tablets, once daily trametinib: oral tablets, once daily
干预措施: trametinib (Drug)
结局指标
主要结局
overall response rate
时间窗: 2.5 years
progression free survival
时间窗: 2.5 years
Incidence rate of dose-limiting toxicities
时间窗: 1.5 years
次要结局
- Incidence and severity of adveres events(2.5 years)
- Plasma concentration(2.5 years)
- Duration of response(2.5 years)
- Time to response(2.5 years)
- Overall survival(3 years)