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

Inclusion Criteria:

1. Sign the informed consent form voluntarily and follow the protocol requirements;

2. Gender is not limited;

3. Age ≥18 years old;

4. Expected survival time ≥3 months;

5. Patients with locally advanced or metastatic non-small cell lung cancer confirmed byhistopathology and/or cytology;

6. Consent to provide an archived tumor tissue sample or fresh tissue sample from theprimary or metastatic site within 6 months for biomarker testing;

7. At least one measurable lesion meeting the RECIST v1.1 definition was required;

8. ECOG ≤1;

9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as definedby NCI-CTCAE v5.0;

10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;

11. The level of organ function must meet the requirements on the premise that no bloodtransfusion and no use of any cell growth factor drugs are allowed within 14 daysbefore the screening period;

12. Coagulation function: international normalized ratio (INR) ≤1.5, and activatedpartial thromboplastin time (APTT) ≤1.5×ULN;

13. Urinary protein ≤2+ or ≤1000mg/24h;

14. Fertile female subjects, or male subjects with fertile partners, must use highlyeffective contraception from 7 days before the first dose until 6 months after thefirst dose. Female subjects of childbearing potential had to have a negative serumpregnancy test within 7 days before the first dose.

Exclusion Criteria:

1. Patients with previous systemic therapy;

2. Cohort_B and Cohort_C were previously treated with EGFR-TKI;

3. Who had participated in any other clinical trial within 4 weeks before the studydose;

4. Received chemotherapy, radiotherapy, biological therapy, immunotherapy and otheranti-tumor treatments within 4 weeks before the first use of study drugs;

5. Had undergone major surgery within 4 weeks before the first dose;

6. History of severe heart disease and cerebrovascular disease;

7. Unstable thrombotic events requiring therapeutic intervention within 6 months beforescreening;

8. QT prolongation, complete left bundle branch block, III degree atrioventricularblock, frequent and uncontrollable arrhythmia;

9. Current interstitial lung disease, drug-induced interstitial pneumonia, radiationpneumonitis requiring steroid therapy, or a history of these diseases;

10. Complicated with pulmonary diseases leading to clinically severe respiratoryfunction impairment;

11. Severe systemic infection within 4 weeks before screening;

12. Patients at risk for active autoimmune disease or with a history of autoimmunedisease;

13. Complicated with other malignant tumors within 5 years before the first dose ofmedication;

14. Human immunodeficiency virus antibody positive, active tuberculosis, activehepatitis 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 poorlycontrolled effusions;

18. Patients with active central nervous system metastases;

19. Imaging examination showed that the tumor had invaded or enveloped the large bloodvessels in the abdomen, chest, neck, and pharynx;

20. Serious unhealed wound, ulcer or fracture within 4 weeks before signing the informedconsent;

21. Subjects with clinically significant bleeding or obvious bleeding tendency within 4weeks before signing the informed consent;

22. Previous history of allogeneic stem cell, bone marrow or organ transplantation;

23. Patients with a history of allergy to recombinant humanized antibody or to any ofthe excipients of BL-B01D1;

24. Had a history of severe neurological or psychiatric disorders;

25. Had a history of autologous or allogeneic stem cell transplantation;

26. Pregnant or lactating women;

27. Subjects scheduled for vaccination or who received live vaccine within 28 daysbefore study randomization;

28. Other conditions for participation in the trial were not considered appropriate bythe investigator.