Patient-derived Tumor-like Cell Cluster Model-based Precision Treatment Strategy on Non-small Cell Lung Cancer

Exclusion Criteria18

• Currently participating in an interventional clinical study treatment, or have received another investigational drug or investigational device within 4 weeks prior to the first dose;
• Have received a proprietary medicine with an anti-tumor indication or an immunomodulatory drug (thymidine, interferon, interleukin, etc.) within 2 weeks prior to the first dose, or have received major surgical treatment within 3 weeks prior to the first dose;
• Presence of active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction and peritoneal metastases requiring clinical intervention;
• Known or screening test findings of active central nervous system (CNS) metastases and/or carcinomatous meningitis;
• Has received a solid organ or blood system transplant;
• Class III-IV congestive heart failure (New York Heart Association classification) with poorly controlled and clinically significant arrhythmias;
• Any arterial thrombosis, embolism or ischemia such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack within 6 months prior to enrolment for treatment. History of deep vein thrombosis, pulmonary embolism, or any other serious thromboembolism within 3 months prior to enrolment (implantable IV port or catheter-derived thrombosis, or superficial venous thrombosis are not considered "serious" thromboembolism);
• Active autoimmune disease requiring systemic therapy (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Alternative therapies (e.g., thyroxine, insulin, or physiological doses of corticosteroids for adrenal or pituitary insufficiency) are not considered systemic therapy;
• Patients requiring long-term systemic corticosteroids. Patients requiring intermittent use of bronchodilators, inhaled corticosteroids, or locally injected corticosteroids due to COPD, asthma may be enrolled;
• Diagnosis of other malignancy within 5 years prior to the first dose, excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ, and if diagnosed with other malignancy or lung cancer more than 5 years prior to the dose, pathological or cytological diagnosis of recurrent metastatic lesions is required;
• Known psychiatric or substance abuse conditions that may have an impact on compliance with the trial requirements;
• Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive), known syphilis infection (syphilis antibody positive), active tuberculosis;
• untreated active hepatitis B; Note: Subjects with hepatitis B who meet the following criteria are also eligible for enrolment: HBV viral load must be \<1000 copies/ml (200 IU/ml) or below the lower limit of detection prior to the first dose of drug, and subjects should be treated with anti-HBV therapy to avoid viral reactivation for the entire duration of the study chemotherapeutic agent treatment. For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required but close monitoring of viral reactivation is needed;
• Subjects with active HCV infection (HCV antibody positive and HCV-RNA levels above the lower limit of detection);
• Live vaccination within 30 days prior to the first dose; NOTE: It is permissible to receive injectable inactivated viral vaccine against seasonal influenza; however, it is not permissible to receive live attenuated influenza vaccine administered intranasally;
• The presence of abnormal results from a medical history, disease, treatment, or laboratory that could interfere with the results of the trial, prevent the subject from participating in the study throughout its duration, or where participation in the study is not, in the opinion of the Investigator, in the best interest of the subject;
• Local or systemic disease, or secondary reactions to cancer, not due to malignancy and which may result in a higher medical risk and/or uncertainty in the evaluation of survival.
• Persons who, in the opinion of the investigator, are not suitable for inclusion.