NCT02834936已完成2 期
A Phase 2 Clinica Study: Efficacy and Safety of Pyrotinib in Patients of Advanced Non-Small Cell Lung Cancer With HER2 Mutation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of Pyrotinib in patients of advanced pre-treated Non-small cell lung cancer With HER2 Mutation.
To observe objective response rate (ORR) of pyrotinib in NSCLC With HER2 Mutation. To observe Progression free survival (PFS). To assess the overall survival (OS).
A secondary aim is to obtain safety information.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG performance status of 0 to
- •Life expectancy of more than 3 months.
- •At least one measurable lesion exists.(RECIST 1.1).
- •Histologically or cytologic confirmed Non-small cell lung cancer, Phase IIIB or IV according to IASLC
- •Failed prior therapies.(RECIST 1.1).
- •Confirmed HER2 mutation by Central Laboratory。
- •More than one prior Platinum based chemotherapy for advanced and/or metastatic, or recurrent NSCLC in neoadjuvant or adjuvant chemotherapy.
- •Required laboratory values including following parameters:
- •ANC: ≥ 1.5 x 10^9/L; Platelet count: ≥ 90 x 10^9/L; Hemoglobin: ≥ 90 g/L; Total bilirubin: ≤ 1.5 x upper limit of normal (ULN); ALT and AST: ≤2 x ULN or ALT and AST: ≤5x ULN for patients with liver metastasis; BUN and Cr: ≤1.5 x ULN； creatine clearance rate: ≥ 50 mL/min; LVEF: ≥ 50%; QTcF: < 470 ms for female and < 450 ms for male.
- •Signed informed consent
排除标准
- •Previous therapy with other HER2 inhibitors.
- •History of severe hypersensitivity reactions to the excipients of the trial drugs.
- •Have clinically significant cavity effusion,such as pleural effusion、 pericardial effusion or ascites and require clinical intervention
- •Active brain metastases
- •Other malignancy within the past (including primary brain tumor or Leptomeningeal tumor), other than basal cell skin cancer or carcinoma in situ of the cervix
- •Persistence of clinically relevant therapy related toxicities from previous therapy (greater than Common Terminology Criteria for Adverse Event(CTCAE) 4.0 grade 1)
- •Treatment with surgery, chemotherapy, radiotherapy or other target therapy within the past 4 weeks before start of therapy
- •Uncontrolled hypertensin,diabetes.
- •unstable angina, history of myocardial infarction in the past 6 months, congestive heart failure>NYHA II, serious cardiac arrhythmia
- •Active infection
- •Variety of factors that affect the oral medication (such as unable to swallow, chronic diarrhea, bowel obstruction and other gastrointestinal disorders or abnormalities
- •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.
- •Treatment in another clinical trial within the past 4 weeks before start of therapy
- •Any of the other conditions of which researchers believe that the patient is not fit to take part in the study.
研究组 & 干预措施
pyrotinib treatment
Experimental
干预措施: pyrotinib (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: tumor assessment every 6-9 weeks after the initiation of pyrotinib, up to 24 months
次要结局
- Progression Free Survival (PFS)(up to 24 months)
- Incidence and Intensity of Adverse Events(From signing informed consent document until 28 days after the last drug administration)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
2 期
Phase II Clinical Study of Pyrotinib in First-line Treatment of Primary HER2-amplified/Mutated Advanced Non-small Cell Lung CancerNon-small Cell Lung CancerNCT05751018Peking Union Medical College Hospital18
Unknown
2 期
Phase 2 Study of Pyrotinib in Previously Treated Patients With NSCLC Having EGFR or ERBB2 Exon 20 Insertion MutationNon Small Cell Lung CancerNCT04063462Tianjin Medical University Cancer Institute and Hospital60
Unknown
2 期
Study to Evaluate the Efficacy and Safety of CDK4/6 Inhibitor SHR6390 Combined With Pyrotinib in the Treatment of HER2-positive Advanced Breast CancerMetastatic Breast CancerNCT03993964Sun Yat-sen University20
撤回
2 期
A Trial of SHR1258 in Patients With Biliary Tract CancerBiliary Tract CancerNCT04571710Jiangsu HengRui Medicine Co., Ltd.70
Unknown
不适用
Neoadjuvant Study of Pyrotinib in Patients With HER2 Positive Breast CancerNeoplasm, BreastBreast DiseasesBreast CancerNCT03756064Zhejiang Cancer Hospital100