An Exploratory Study of Efficacy and Safety of Iruplinalkib Tablets in Patients With ROS1 Positive Non-small Cell Lung Cancer

Exclusion Criteria

• •1. 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
• •2. Mixed small cell and NSCLC histology
• •3. Known history or evidence of interstitial lung disease or active non-infectious pneumonia
• •4. 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)
• •5. 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
• •6. 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
• •7. 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)
• •8. Patients with pleural effusion, ascites, or pericardial effusion requiring drainage can be enrolled if their symptoms are assessed to be stable after drainage
• •9. 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
• •10. Live vaccine was administered within 4 weeks prior to or possibly during the study period
• •11. The presence of active gastrointestinal (GI) disease or other conditions that significantly interfere with the absorption, distribution, metabolism, or excretion of the investigational drug
• •12. Known allergy to the investigational drug or its excipients
• •13. 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.