A Study of XZP-3621 in Chinese Patients With ALK Positive NSCLC

Exclusion Criteria

• •Patients who meet any of the following criteria will be excluded from study entry:
• •1. Combined with small cell lung cancer;
• •2. Uncontrolled malignant pleural/peritoneal effusion and/or pericardial effusion (uncontrolled means that the effusion increases significantly within one week after extraction and has obvious symptoms requiring further puncture or other intervention) ;
• •3. Patients with a previous malignancy within the past 5 years are excluded (other than curatively treated basal cell carcinoma of the skin, early gastrointestinal (GI) cancer by endoscopic resection, in situ carcinoma of the cervix.);
• •4. Previous treatment history of organ transplantation, hematopoietic stem cell or bone marrow transplantation;
• •5. Patient has had major surgery within 4 weeks prior (2 weeks for resection of brain metastases) to the first dose of study drug or has not recovered from side effects of such procedure;
• •6. Active and clinically significant bacterial, fungal, or viral infection including hepatitis B virus (HBV) or hepatitis C virus (HCV) (eg, in case of known HBsAg or HCV antibody positivity);
• •7. Known human immunodeficiency virus (HIV);
• •8. Clinically active infections affecting the safety of subjects, including active tuberculosis;
• •9. Uncontrolled hyperglycemia;
• •10. Subject with predisposing characteristics for acute pancreatitis according to investigator judgment, including but not limited to current gallstone disease,history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease within 28 days of initial administration;
• •11. Subject with uncontrolled electrolyte disturbances (e.g., low calcium, low magnesium, or hypokalemia) that are identified by investigator;
• •12. Unable to swallow;
• •13. History of extensive, disseminated, bilateral or presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis and pulmonary fibrosis;
• •14. Clinically significant vascular (both arterial and venous) and non-vascular cardiac conditions, (active or within 3 months prior to enrollment), which may include, but are not limited to:
• •1. Arterial disease such as cerebral vascular accident/stroke (including Transient Ischemic Attack -TIA), myocardial infarction, unstable angina;
• •2. Venous diseases such as cerebral venous thrombosis, symptomatic pulmonary embolism;
• •3. Non-vascular cardiac disease such as congestive heart failure (New York Heart Association Classification Class ≥ II), second-degree or third-degree AV block (unless paced) or any AV block with PR \>220 msec; or ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥2, uncontrolled atrial fibrillation of any grade, bradycardia defined as \<50 bpm (unless patient is otherwise healthy such as long-distance runners, etc.), machine-read Electrocardiogram (ECG) with QTc \>470 msec, or congenital long QT syndrome;
• •15. Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) ≥ 150 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 95 mm Hg;
• •16. Patient has impairment of GI function or GI disease that may significantly alter the absorption of XZP-3621 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome);
• •17. Patient receiving treatment with medications that meet one of the following criteria and that cannot be discontinued at least 14 days prior to the start of treatment with XZP-3621 and for the duration of the study;
• •* Strong inhibitors or strong inducers of CYP3A4.
• •* Medications with a known risk of prolonging the QT interval or inducing Torsades de Pointes.
• •18. Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation;
• •19. Pregnant female patients; breastfeeding female patients;
• •20. History of hypersensitivity to any of the additives in the XZP-3621 or crizotinib drug formulation;
• •21. Other severe acute or chronic medical or psychiatric condition, including recent (within the past year) or active suicidal ideation or behavior;
• •22. laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator and/or the sponsor, would make the subject inappropriate for entry into this study.