A Study of AL8326 in Non-Small Cell Lung Cancer

Exclusion Criteria

• •1. The patient used AL8326 tablets.
• •2. Allergic to AL8326 or its analogues, or to any component in the prescription of AL8326;
• •3. The last dose of systemic cytotoxic or investigational therapy was administered within 28 days prior to initiation of study treatment. Or the last dose of a non-cytotoxic, non-investigational treatment (i.e., radiation therapy, hormone therapy, targeted therapy, immunotherapy, etc.) was administered within 14 days prior to initiation of study treatment;
• •4. Major surgery (defined as requiring general anesthesia within 28 days prior to initiation of study treatment or general anesthesia for minor surgical procedures within 7 days prior to initiation of study treatment).
• •5. Pregnant or lactating female patients.
• •6. History of a prior or concurrent second primary malignancy that, in the opinion of the investigator or sponsor, may interfere with the assessment of the safety or efficacy of the investigational therapeutic agents.
• •7. Patients with active or untreated central nervous system（CNS） metastases; subjects with stabilized brain metastases will need to meet the following criteria for enrollment: a) no imaging-proven progression ≥4 weeks after completion of treatment; b) completion of treatment within ≥28 days prior to the first dose of the test drug; and c) no need to be treated with systemic corticosteroids (\>10 mg/day of prednisone or equivalent dose) ≤28 days prior to the first dose of the test drug.
• •8. Peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal disease with risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to starting study treatment.
• •9. The patients have had an arterial/venous thrombotic event such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism within 6 months prior to screening;
• •10. Presence of uncontrolled infection (within 2 weeks prior to administration of test drug).
• •11. New York Heart Association (NYHA) class III or IV congestive heart failure as achieved by cardiac function.
• •12. Had the following history of heart disease within 6 months before starting study treatment:
• •1. Cardiac angioplasty or stenting, or
• •2. Myocardial infarction, or
• •3. Unstable angina, or
• •4. Cerebrovascular accident
• •13. Imaging showed that the tumor had invaded around important blood vessels, or the investigator judged that the tumor was very likely to invade important blood vessels during the follow-up study and cause fatal massive hemorrhage;
• •15.With ascites or uncontrollable pleural effusion (CTCAE 5.0 ≥ grade 2). 16.Evidence of hemorrhagic idiosyncrasies or coagulation disorders or clinically significant bleeding (such as gross hematuria, gastrointestinal bleeding, and hemoptysis) detected within 6 months prior to initiation of study treatment.
• •17.Patients treated with anticoagulants or vitamin K antagonists (such as warfarin, heparin, or their analogues); Under the premise that the international standardized ratio of prothrombin time (INR) is ≤ 1.5, it is allowed to use low-dose anticoagulants for preventive purposes, such as warfarin (no more than 1mg per day, oral), low-dose heparin (no more than 12000 U per day), or low-dose aspirin (no more than 100mg per day); 18.There are arrhythmias that need clinical intervention (such as long QT syndrome, QTc corrected by fridericia formula is not measurable or \> 450 ms in men and \> 470 MS in women); 19.Within 28 days before starting the study treatment, urine protein was ≥ + +, and 24-hour urine protein quantitation was \> 1.0g; 20.Hepatitis B surface antigen is positive and hepatitis B virus load (HBV-DNA) is higher than the lower limit of local laboratory detection, anti hepatitis C antibody is positive and hepatitis C virus load (HCV-RNA) is higher than the lower limit of local laboratory detection, Treponema pallidum antibody is positive, and human immunodeficiency virus anti physical examination result is positive.
• •21.History of organ transplantation. 22.Clinical symptoms affecting the intake or absorption of AL8326 (such as inability to swallow, chronic diarrhea, intestinal obstruction, malabsorptive disease, total gastrectomy or small bowel resection); 23.Prohibited combination drug therapy within 14 days prior to initiation of study treatment.
• •24.Red blood cell or platelet transfusion within 14 days prior to initiation of study treatment.
• •25.Any serious and/or unstable pre-existing medical, psychiatric, or other condition that may jeopardize the subject's safety, obtaining informed consent, or compliance with study procedures or study objectives.
• •26.Any other reason that, in the judgment of the investigator, makes participation in this study inappropriate.