Recombinant Human Angioendostatin /PD-1 Mab Combined With First-line Chemotherapy in the Treatment of Driver Gene Negative Advanced NSCLC

Exclusion Criteria

• •Patients with any of the following conditions will not be enrolled in this study:
• •1. Severe allergic reaction to humanized antibodies or fusion proteins;
• •2. known hypersensitivity to Endu or any component contained in antibody preparations;
• •3. Subjects have been diagnosed as immunodeficient or are receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 14 days prior to the study's initial administration and are permitted to use physiological doses of glucocorticoids (≤10mg/ day of prednisone or equivalent);
• •4. Subjects with active, known or suspected autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, and hypothyroidism, including but not limited to these diseases or syndromes) were excluded. Subjects with type 1 diabetes, hypothyroidism that requires only hormone replacement therapy, skin conditions that do not require systemic treatment (e.g: vitiligo, psoriasis, or hair loss), or conditions that are not expected to recur in the absence of an external trigger can be enrolled;
• •5. Patients with pre-existing serious heart disease, including congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina pectoris, myocardial infarction, and severe valvular disease;
• •6. Patients who have previously received targeted drug therapy with vascular endothelial growth inhibitors, such as bevacizumab, sunitinib, sorafenib, imatinib, famitinib, rigafenib, apatinib, anlotinib, etc.
• •7. Systemic antitumor therapy, including cytotoxic therapy, signal transduction inhibitors, or immunotherapy (or mitomycin C in the 6 weeks prior to receiving the study drug), was planned within 4 weeks prior to the group or during the duration of the study. Field expanding radiotherapy (EF-RT) was performed within 4 weeks prior to grouping or field limiting radiotherapy was performed within 2 weeks prior to grouping.
• •8. Presence of active hepatitis B (HBV DNA ≥ 2000IU/ml or 104copies/ml), hepatitis C (positive hepatitis C antibody, and HCV-RNA higher than the lower limit of analysis).
• •9. According to chest X-ray examination, sputum examination and clinical examination, active tuberculosis (TB) infection was determined. Patients with a history of active tuberculosis infection within the previous year, even if treated, should be excluded; Patients with a history of active tuberculosis infection more than one year ago should also be excluded unless the duration and type of antituberculosis therapy previously used are demonstrated to be appropriate.
• •10. Patients with BMS with symptoms or symptom control for less than 2 months;
• •11. Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before grouping;
• •12. Patients whose imaging shows that the tumor has invaded important blood vessels or the investigator judges that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during the follow-up study;
• •13. Patients with any evidence or history of bleeding, regardless of severity; Patients with any bleeding or bleeding event ≥CTCAE grade 3 within 4 weeks prior to grouping had unhealed wounds, ulcers or fractures;
• •14. Experienced arteriovenous/venous thrombosis events within 6 months, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism;
• •15. Concomitant diseases that, according to the investigator's judgment, seriously endanger the patient's safety or affect the patient's ability to complete the study.