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

Inclusion Criteria:

1. Voluntarily sign the informed consent and follow the requirements of the protocol;

2. No gender limit;

3. Age ≥18 years old;

4. Expected survival time ≥3 months;

5. Patients with histologically and/or cytologically confirmed locally advanced ormetastatic non-small cell lung cancer;

6. Documentation of EGFR sensitive mutations detected from tumor tissue or bloodsamples;

7. Consent to provide archived tumor tissue or fresh tissue samples from primary ormetastatic sites within 2 years for biomarker testing;

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

9. ECOG ≤1;

10. Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined byNCI-CTCAE v5.0;

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

12. The level of organ function must meet the requirements on the premise that bloodtransfusion is not allowed within 14 days before the screening period and no cellgrowth factor drugs are allowed;

13. Blood coagulation function: international standardization ratio of 1.5 or less, andthe part activated clotting time live enzymes acuities were 1.5 x ULN;

14. Urine protein ≤2+ or ≤1000mg/24h;

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

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 thetrial dose;

4. Traditional Chinese medicine (TCM) which had received radiotherapy within 4 weeksbefore the first use of the study drug and had anti-tumor indications within 2 weeksbefore 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 beforescreening; Infusion-related thrombosis was excluded;

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

9. Previous history of interstitial lung disease requiring steroid therapy, or currentILD or grade ≥2 radiation pneumonitis;

10. Complicated pulmonary diseases leading to clinically severe respiratory functionimpairment;

11. Severe systemic infection within 4 weeks before screening;

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

13. Other malignant tumors within 5 years before the first dose;

14. HIV antibody positive, active tuberculosis, active hepatitis B virus infection, orhepatitis 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. Severe unhealed wound, ulcer, or fracture within 4 weeks before consent signing;

21. Sign a four weeks before there were clinically significant bleeding or bleedingtendency 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 ofthe 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 bythe investigator.