NCT06436885招募中早期 1 期
An Exploratory Study of Efficacy and Safety of Iruplinalkib Tablets in Patients With ROS1 Positive Non-small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
This is a single-arm, open, multicenter exploratory clinical trial to observe and evaluate the efficacy and safety of Iruplinalkib Tablets in patients with ROS1 positive non-small cell lung cancer.
详细描述
Iruplinalkib Tablets should be administered orally at a roughly fixed time each day. Once daily, on an empty stomach or with food, 60mg per dose for days 1 to 7, 180 mg per dose from day 8 if tolerated. Swallow the tablet whole, do not crush, divide or chew the tablet.
The primary end point was objective response rate
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
- •Volunteer to join the study and sign the informed consent
- •≥18 years old
- •Histologically or cytologically confirmed stage III unresectable or stage IV ROS1 positive non-small cell lung cancer
- •The ECOG performance status is 0-2
- •At least one measurable lesion according to RECIST 1.1
- •Can swallow pills normally
- •No brain metastases, or asymptomatic brain metastases, or symptomatic brain metastases that are stable for >4 weeks after treatment
- •The function of vital organs meets the following requirements (no blood component, cell growth factor drugs are allowed within 14 days before the first medication):
- •Absolute neutrophil count ≥1.5×109/L Platelet ≥100×109/L Hemoglobin ≥90 g/L Serum albumin ≥30 g/L Serum total bilirubin ≤1.5×ULN ALT and AST≤ 2.5 x ULN; if liver metastasis exists, ALT and AST≤5ULN AKP≤ 2.5×ULN Serum creatinine ≤1.5×ULN International Standardized Ratio (INR) ≤1.5×ULN (not receiving anticoagulation therapy)
- •Non-surgical sterilization or female patients of reproductive age who are required to use a medically approved contraceptive method (such as an IUD, contraceptive pill or condom) during the study treatment period and for 3 months after the end of the study treatment period; Serum or urine HCG tests must be negative for women of childbearing age who have been sterilized without surgery within 7 days prior to the first dose. And must be non-lactation period; For male patients whose partner is a woman of reproductive age, effective contraception should be used during the trial and within 3 months after the last dose of the trial drug
排除标准
- •Patients who are participating in another clinical study or are receiving another investigational drug, or who received the investigational device within 4 weeks prior to the first treatment of our investigational drug. Patients may be included in this study if they are participating in a non-interventional clinical trial
- •Mixed small cell and NSCLC histology
- •Known history or evidence of interstitial lung disease or active non-infectious pneumonia
- •Have had other malignancies within the past 5 years or at the same time (except cured basal cell carcinoma of the skin and cervical carcinoma in situ)
- •Prior surgery or immunotherapy must be completed at least 4 weeks, and radiotherapy must be completed at least 2 weeks before the investigational drug begins
- •Have high blood pressure that is not well controlled by antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg); Allow the above parameters to be achieved through the use of antihypertensive therapy; A history of hypertensive crisis or hypertensive encephalopathy
- •Have clinical symptoms or diseases of heart that are not well controlled, such as: (1) NYHA2 or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention, (5) QTc>450ms (male); QTc>470ms (Female)
- •Patients with pleural effusion, ascites, or pericardial effusion requiring drainage can be enrolled if their symptoms are assessed to be stable after drainage
- •Congenital or acquired immune deficiency (such as HIV infection); Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥2000 IU/ml, or hepatitis C virus antibody positive
- •Live vaccine was administered within 4 weeks prior to or possibly during the study period
- •The presence of active gastrointestinal (GI) disease or other conditions that significantly interfere with the absorption, distribution, metabolism, or excretion of the investigational drug
- •Known allergy to the investigational drug or its excipients
- •According to the investigator's judgment, the patient has other factors that may affect the study results or lead to the forced termination of the study, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring combined treatment, serious laboratory abnormalities, and family or social factors, which will affect the safety of the patient.
研究组 & 干预措施
Treatment group
Experimental
Iruplinaakib tablets should be administered orally at a roughly fixed time each day. Once daily, on an empty stomach or with food, 60mg per dose for days 1 to 7, 180 mg per dose from day 8 if tolerated. Swallow the tablet whole, do not crush, divide or chew the tablet
干预措施: Iruplinalkib tablets (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: up to 24 months
次要结局
未报告次要终点
研究者
Yanqiu Zhao
professor of medicine
Henan Cancer Hospital
研究点 (1)
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