Single Arm Phase II Clinical Trial to Investigate the Efficacy and Safety of Pyrotinib as a Single Agent in HER2 Mutation Advanced Non-small Cell Lung Cancer Patients Who Failed to Previous at Least 2nd Line Treatments
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
Various driver gene mutations have been identified in lung cancer. Among them, human epidermal growth factor 2 (HER2) was identified in about approximately 2% of non-small cell lung cancers.Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is designed to evaluate the efficacy and safety of Pyrotinib in patients with HER2 positive advanced Non-small cell lung cancer.
详细描述
This study is designed to evaluate the efficacy and safety of Pyrotinib in patients with HER2 positive advanced pre-treated Non-small cell lung cancer.
To observe objective response rate (ORR) of pyrotinib in HER2 positive NSCLC. To observe Progression free survival （PFS）. To assess the overall survival (OS). To assess side effects. To evaluate quality of life. To explore the relationship between biomarkers and the toxicity/efficacy of Pyrotinib.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 and ≤80 years.
- •ECOG performance status of 0 to
- •Life expectancy of more than 12 weeks.
- •At least one measurable lesion exists.(RECIST 1.1)
- •Histologically or cytologic confirmed HER2 positive advanced Non-small cell lung cancer who failed prior therapies.
- •Required laboratory values including following parameters:
- •ANC: ≥ 1.5 x 10^9/L, Platelet count: ≥ 80 x 10^9/L, Hemoglobin: ≥ 90 g/L, Total bilirubin: ≤ 1.5 x upper limit of normal, ULN, ALT and AST: ≤ 1.5 x ULN, BUN and creatine clearance rate: ≥ 50 mL/min LVEF: ≥ 50% QTcF: < 470 ms
- •Signed informed consent.
排除标准
- •Subjects with third space fluid that can not be controled by drainage or other methods.
- •Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption.
- •Less than 4 weeks from the last radiotherapy,chemotherapy,target therapy
- •Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
- •Subjects who can not interrupt the using of the drugs that may cause QT prolongation during study.
- •Receiving any other antitumor therapy.
- •Known history of hypersensitivity to pyrotinib or any of it components. Ongoing infection (determined by investigator).
- •History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
- •Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial.
- •Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test.
- •Known history of neurological or psychiatric disease, including epilepsy or dementia.
研究组 & 干预措施
Pyrotinib treatment arm
pyrotinib treatment arm
干预措施: Pyrotinib (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: tumor assessment every 6-8 weeks after the initiation of pyrotinib, up to 24 months
To evaluate objective response rate 6-8 weeks after the initiation of pyrotinib
次要结局
- Progression Free Survival(24 months)
研究者
Caicun Zhou
MD,PhD
Tongji University