A Study Comparing BL-B01D1 With Platinum Based Chemotherapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer(PANKU-Lung01)

Inclusion Criteria:

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

2. Age ≥18 years old;

3. Expected survival time ≥3 months;

4. Histologically or cytologically confirmed locally advanced or metastaticnon-squamous non-small cell lung cancer;

5. Documented classical EGFR mutations detected from tumor tissue or blood samples;

6. Had not received any systemic therapy other than EGFR-TKIs;

7. Radiographic disease progression documented during or after third-generationEGFR-TKI therapy for metastatic or locally advanced disease;

8. Consent to provide archival tumor tissue samples or fresh tissue samples of primaryor metastatic lesions within 3 years;

9. Must have at least one measurable lesion according to RECIST v1.1 definition;

10. ECOG score 0 or 1;

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

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

13. 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;

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

15. Urine protein ≤2+ or < 1000mg/24h;

16. For premenopausal women with childbearing potential, a pregnancy test must beperformed within 7 days before the start of treatment, serum or urine must benegative for pregnancy, and must be non-lactating; All enrolled patients (male orfemale) were advised to use adequate barrier contraception throughout the treatmentcycle and for 6 months after the end of treatment.

Exclusion Criteria:

1. The patient has histologic or cytologic evidence of small cell or mixedsmall/non-small cell component or squamous non-small cell lung cancer;

2. Chemotherapy, biological therapy, immunotherapy, etc., have been used within 4 weeksor 5 half-lives before the first dose, small molecule targeted therapy has been usedwithin 5 days, palliative radiotherapy or anti-tumor therapy has been used within 2weeks;

3. Previous treatment with: a. an ADC with TOPI inhibitor as toxin; b. any systemictherapy in the context of metastatic/locally advanced disease;

4. The history of severe cardiovascular and cerebrovascular diseases in the past sixmonths prior screening;

5. Thrombotic events requiring therapeutic intervention within 6 months beforescreening; Infusion-related thrombosis more than 4 weeks later was excluded;

6. Complete left bundle branch block, III degree atrioventricular block, frequent anduncontrolled severe arrhythmia;

7. Other malignancies diagnosed within 3 years before randomization;

8. Hypertension poorly controlled by two antihypertensive drugs;

9. History of interstitial lung disease (ILD) requiring steroid therapy, or current ILDor grade ≥2 radiation pneumonitis;

10. Patients with poor glycemic control;

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

12. Patients with active central nervous system (CNS) metastases;

13. Severe infection within 4 weeks before randomization; Evidence of pulmonaryinfection or active pulmonary inflammation within 2 weeks before randomization;

14. Patients with massive or symptomatic effusions or poorly controlled effusions;

15. Imaging examination showed that the tumor had invaded or wrapped the abdomen, chest,neck, and large blood vessels;

16. Severe unhealed wound, ulcer, or fracture within 4 weeks before signing the informedconsent;

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

18. Patients with inflammatory bowel disease, extensive bowel resection history, immuneenteritis history, intestinal obstruction or chronic diarrhea;

19. Have a history of allergy to recombinant humanized antibodies or any of theingredients of BL-B01D1;

20. Human immunodeficiency virus antibody positive, active hepatitis B virus infection,or hepatitis C virus infection;

21. A history of severe neurological or psychiatric illness;

22. Received other unmarketed investigational drug or treatment within 4 weeks beforerandomization;

23. Subjects who were scheduled to receive live vaccine or received live vaccine within 28 days before study randomization;

24. Other circumstances that were assessed by the investigator as inappropriate forparticipation in the trial.