NCT05751018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 Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
This is a multicenter, single-arm phase II clinical study to evaluate the safety and efficacy of pyrotinib maleate as a first-line treatment for HER2-mutated or amplified non-small cell lung cancer. Pyrotinib maleate is a small molecule tyrosine kinase inhibitor that can irreversibly inhibit HER1, HER2, and HER4.
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
- •1. Age: ≥18 years old;
- •Histologically confirmed stage IIIB or IV non-small cell lung cancer;
- •Have not previously received systemic anticancer therapy for stage IIIB or IV NSCLC;
- •HER2 insertion mutation, primary HER2 point mutation or primary HER2 amplification confirmed by genetic testing of tumor tissue or blood, pleural effusion, cerebrospinal fluid and other specimens;
- •There is at least one measurable lesion determined based on RECIST 1.1;
- •ECOG score 0-1 points;
- •Expected survival period ≥ 12 weeks;
- •Cardiac ultrasound examination showed that left ventricular ejection fraction (LVEF) ≥ 50%;
- •The patient's bone marrow function, liver and kidney function were confirmed to meet the following requirements by laboratory tests before the first administration:
- •Neutrophil count (ANC) ≥ 1,500/mm3 (1.5×109/L);
- •Platelet count (PLT) ≥ 75,000/mm3 (75×109/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) level ≤ 2.5 times the upper limit of normal (ULN), patients with liver metastases should be ≤ 5×ULN.
- •10. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
排除标准
- •1. Previous use of EGFR TKI therapy;
- •Participated in clinical trials of other drugs within 4 weeks before the start of the study;
- •Symptomatic brain metastases or meningeal metastases;
- •Insufficient bone marrow reserve or insufficient organ function;
- •Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow drugs, etc., may affect the intake, transport or absorption of drugs;
- •Received major surgical operation or severe traumatic injury, fracture, or poor healing wound within 4 weeks;
- •Known history of other malignancies, unless the subject has received potentially curative therapy prior to initiation of therapy and has at least 3 years of evidence of disease-free recurrence (non-small cell lung cancer, radical skin basal cell undergoing successful resection) carcinoma, superficial bladder cancer, squamous cell carcinoma of the skin, cervical carcinoma in situ or other carcinoma in situ);
- •Those who have serious adverse reactions and allergies to the drugs and excipients used in this group;
- •Pregnant or lactating female patients, female patients with fertility and positive baseline pregnancy test, or patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial;
- •The patient has serious concomitant diseases, or any other condition that the investigator considers the patient unsuitable to participate in this study.
研究组 & 干预措施
pyrotinib
Experimental
干预措施: Pyrotinib (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)
- DCR(2 year)
- QoL(1 year)
研究者
研究点 (1)
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