A Study to Evaluate the Safety and Tolerability of SCTB14 as First-Line Therapy in Non-Small Cell Lung Cancer.

Exclusion Criteria

• •1. Known actionable driver gene mutations such as ROS1 fusion, BRAF V600E mutation, NTRK fusion, MET exon 14 skipping mutation, and RET fusion mutation.
• •2. Received non-specific immunomodulatory therapy or immunosuppressive drugs within 2 weeks before the first dose; received traditional Chinese medicine with antineoplastic indications within 1 week before the first dose.
• •3. Prior thoracic radiotherapy; or local anti-tumor therapy within 2 weeks before first dosing.
• •4. Prior treatment with antitumor immunotherapy, antiangiogenic therapy, or other small molecule tyrosine kinase inhibitor (TKI)-based antitumor drugs.
• •5. subjects with metastasis or compression involving the brainstem, meninges, or spinal cord, or those with active CNS metastases or multiple brain metastases.
• •6. Imaging demonstrates tumor invasion of major blood vessels, significant necrosis or cavitation within the primary tumor lesions, or the presence of lymphangitic carcinomatosis.
• •7. Imaging demonstrates tumor invasion or compression of adjacent vital organs or carries a risk of developing an esophagotracheal fistula or esophagopleural fistula.
• •8. History of hypertensive crisis or hypertensive encephalopathy, or the presence of uncontrolled hypertension despite medication, or poorly controlled diabetes despite pharmacotherapy.
• •9. A history of arterial thrombosis, deep vein thrombosis, cerebral infarction, transient ischemic attack, or significant vascular disease within 6 months prior to enrollment.
• •10. A history of myocardial infarction, unstable angina, cardiac insufficiency with New York Heart Association (NYHA) class ≥ III, or severe arrhythmia uncontrolled by medication within 6 months prior to enrollment.
• •11. The presence of any active autoimmune disease or a history of autoimmune disease with an anticipated recurrence.
• •12. A history of esophageal/gastric varices, severe ulcer, abdominal fistula, intra-abdominal abscess, gastrointestinal perforation and/or fistula, acute gastrointestinal bleeding, intestinal obstruction, or extensive intestinal resection within 6 months prior to the first dose.
• •13. A history of bleeding tendency, high bleeding risk, or coagulation dysfunction,.
• •14. The presence of other malignant tumors.
• •15. Toxicities from prior neoadjuvant/adjuvant therapy, surgery, radiotherapy, or other previous antitumor treatments have not recovered to Grade 0-1.
• •16. Receipt of a live or attenuated vaccine within 4 weeks prior to the first dose, or a plan to receive a live or attenuated vaccine during the study period; however, the use of inactivated vaccines is permitted.
• •17. Presence of any of the following infectious conditions: a) severe infection within 4 weeks prior to the first dose; b) active infection within 2 weeks prior to enrollment; c) active tuberculosis; d) positive HIV antibody; e) active hepatitis B or C; f) known active syphilis.
• •18. Major surgery planned or anticipated during the study period, or unhealed tissue present before enrollment..
• •19. Presence of symptomatic or recurrent pleural effusion, pericardial effusion, or ascites requiring drainage.
• •20. A history of non-infectious pneumonia requiring treatment or the presence of interstitial lung disease
• •21. A history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• •22. Known hypersensitivity to any component of the investigational drug or a documented history of severe hypersensitivity reactions to any other monoclonal antibody.
• •23. Current participation in another clinical trial, with the exception of observational (non-interventional) studies or the follow-up phase of an interventional trial.
• •24. Pregnancy or lactation in female subjects.
• •25. A known history of alcohol or drug addiction, psychiatric disorders, or drug abuse in the subject.
• •26. Tumor-induced conditions or symptoms associated with a high medical risk.
• •27. Any other condition deemed by the investigator to be inappropriate for enrollment.