A Study of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Exclusion Criteria

• •1. Patients with prior systemic therapy;
• •2. Previous treatment with EGFR-TKI;
• •3. Participants who participated in any other clinical trial within 4 weeks before the trial dose;
• •4. Traditional Chinese medicine (TCM) which had received radiotherapy within 4 weeks before the first use of the study drug and had anti-tumor indications within 2 weeks before the first use of the study drug;
• •5. Had undergone major surgery within 4 weeks before the first dose;
• •6. History of severe heart disease or cerebrovascular disease;
• •7. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;
• •8. QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
• •9. Previous history of interstitial lung disease requiring steroid therapy, or current ILD or grade ≥2 radiation pneumonitis;
• •10. Complicated pulmonary diseases leading to clinically severe respiratory function impairment;
• •11. Severe systemic infection within 4 weeks before screening;
• •12. Patients at risk for active autoimmune disease or with a history of autoimmune disease;
• •13. Other malignant tumors within 5 years before the first dose;
• •14. HIV antibody positive, active tuberculosis, active hepatitis B virus infection, or hepatitis C virus infection;
• •15. Hypertension poorly controlled by two antihypertensive drugs;
• •16. Patients with poor glycemic control;
• •17. Patients with massive effusions, or effusions with obvious symptoms, or poorly controlled effusions;
• •18. Patients with active central nervous system metastases;
• •19. Imaging examination showed that the tumor had invaded or enveloped the large blood vessels in the abdomen, chest, neck, and pharynx;
• •20. Severe unhealed wound, ulcer, or fracture within 4 weeks before consent signing;
• •21. Sign a four weeks before there were clinically significant bleeding or bleeding tendency obviously subjects;
• •22. Previous history of allogeneic stem cell, bone marrow or organ transplantation;
• •23. Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of BL-B01D1;
• •24. A history of severe neurological or psychiatric illness;
• •25. Pregnant or lactating women;
• •26. Subjects who were scheduled to receive live vaccine or received live vaccine within 28 days before study randomization;
• •27. Other conditions for participation in the trial were not considered appropriate by the investigator.