NCT05411276尚未招募不适用
A Real-World Study of Pyrotinib Maleate in the Treatment of Advanced/Metastatic Non-Small Cell Lung Cancer With Rare Mutations in HER2
Beijing Chest Hospital0 个研究点目标入组 15 人开始时间: 2022年6月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 主要终点
- ORR
研究概览
简要总结
At present, the main characteristics of the enrolled population in the clinical study of HER2-mutated non-small cell lung cancer are the YVMA mutation type. There are no relevant clinical trials specifically targeting rare mutation types. Pyrotinib has been approved for the treatment of HER2-positive advanced breast cancer in China, and pyrotinib has shown good development prospects in the treatment of advanced non-small cell lung cancer. The purpose of this study is to observe the efficacy and safety of pyrotinib maleate in patients with HER2 rare mutation in advanced non-small cell lung cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-70 years old;
- •Advanced/metastatic non-small lung cancer (IV) confirmed by pathology with measurable lesions;
- •HER2 mutation and amplification confirmed by gene testing of tumor tissue or blood, pleural effusion, cerebrospinal fluid and other specimens;
- •At least one radiographically measurable lesion
- •Expected survival period ≥ 3 months
- •Left ventricular ejection fraction (LVEF) ≥ 50% on echocardiography
- •Before using the drug for the first time, it was confirmed by laboratory tests that the subject's bone marrow function, liver and kidney function met the following requirements：
- •Neutrophil count (ANC) ≥ 1,500/mm3 (1.5×109/L);
- •Platelet count (PLT) ≥ 100,000/mm3 (100×109/L);
- •Hemoglobin (Hb) ≥ 8 g/dL (80 g/L);
- •Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 60 ml/min;
- •Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels ≤ 2.5 times the upper limit of normal (ULN), and subjects with liver metastases should be ≤ 5×ULN;
- •International normalized ratio (INR) ≤ 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN;
- •Urine protein <2+; if urine protein ≥2+, the 24-hour urine protein quantification shows that protein must be ≤1g;
- •The medication regimen of the subjects during the clinical diagnosis and treatment was pyrotinib as a single drug
- •Patients voluntarily entered the study and signed informed consent form (ICF)
排除标准
- •Common types of HER2 mutations: YVMA mutations;
- •Patients with hypertension that cannot be well controlled by antihypertensive drug treatment (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg); Uncontrolled or severe cardiovascular disease, such as refractory angina pectoris, congestive heart failure occurred within 6 months before screening; Myocardial infarction within 12 months prior to screening; Any history of clinically significant ventricular arrhythmia, prolonged QT interval; History of cerebrovascular accident, symptomatic coronary heart disease requiring drug treatment;
- •There are significant digestive tract dysfunction, which may affect the intake, transport or absorption of oral drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
- •Subjects with a recent history of active bleeding, clinically significant bleeding symptoms, and a clear bleeding tendency, such as hemoptysis, gastrointestinal bleeding, hemorrhagic gastric ulcer, positive fecal occult blood at baseline and above, etc.;
- •Major surgical operations or severe traumatic injuries, fractures, or poorly healing wounds have been received within 4 weeks;
- •Uncontrollable history of important respiratory system such as bronchiectasis, chronic obstructive pulmonary disease, lung abscess, pulmonary embolism, etc.;
- •Active serious clinical infection (>NCI-CTCAE, 5.0 version 2 infection standard) and viral infections such as hepatitis B, hepatitis C, syphilis and HIV;
- •Symptomatic brain metastases or meningeal metastases;
- •Combined with previously untreated tumors other than primary lung cancer;
- •Participated in clinical trials of other drugs within 4 weeks before the start of the study;
- •Received treatment with pyrotinib maleate;
- •Those who have serious adverse reactions and allergies to pyrotinib maleate;
- •Pregnant or lactating female subjects, female subjects who are fertile and have a positive baseline pregnancy test, or subjects of childbearing age who are unwilling to take effective contraceptive measures throughout the trial;
- •Have serious concomitant diseases, or any other conditions that the investigator considers unsuitable to participate in this study.
研究组 & 干预措施
Group 1
HER2 rare mutation advanced/metastatic non-small lung cancer (IV)
干预措施: Pyrotinib maleate (Drug)
结局指标
主要结局
ORR
时间窗: 2 Year
It is defined as the proportion of patients whose tumors shrink to a predetermined size and maintain a minimum time limit. It includes the cases of CR and PR.
次要结局
- PFS(1 Year)
- AEs and SAEs(1 Year)
- QoL(1 Year)
- OS(2 Year)
- DCR(2 Year)
研究者
Ying Hu
Director of the Second Department of Oncology
Beijing Chest Hospital
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