A Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer(PANKU-Lung04)

This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib versus osimertinib as first-Line treatment in patients with EGFR-mutated locally advanced or metastatic Non-small Cell Lung Cancer.

Inclusion Criteria: 1. Sign the informed consent form voluntarily and follow the protocol requirements; 2. Age ≥18 years old; 3. Expected survival time ≥3 months; 4. Patients with unresectable or radical radiotherapy for locally advanced non-small cell lung cancer; 5. Documentation of EGFR sensitive mutations detected from tumor tissue or blood samples; 6. Consent to provide archived tumor tissue samples or fresh tissue samples of primary or metastatic lesions at or after diagnosis for testing, including EGFR mutation type; 7. At least one measurable lesion meeting the RECIST v1.1 definition was required; 8. ECOG 0 or 1; 9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0; 10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%; 11. The organ function level must meet the requirements on the premise that blood transfusion and colony-stimulating factor are not allowed within 14 days before the screening period; 12. Urinary protein ≤2+ or \< 1000mg/24h; 13. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, serum pregnancy must be negative, and the patient must not be lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment. Exclusion Criteria: 1. Previous histologic or cytological evidence of small cell or mixed small/non-small cell components; 2. Patients with previous systemic therapy; 3. Patients had received EGFR-TKI therapy; 4. Studies received radical radiotherapy, major surgery, and large area radiotherapy within 4 weeks before randomization; 5. History of severe heart disease and cerebrovascular disease; 6. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded; 7. QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia; 8. Were diagnosed with active malignancy within 3 years before randomization; 9. Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \&gt; 150 mmHg or diastolic blood pressure \&gt; 100 mmHg); 10. Patients with poor glycemic control; 11. A history of ILD requiring steroid therapy, or current ILD or grade ≥2 radiation pneumonitis, or a suspicion of such disease; 12. Complicated with pulmonary diseases leading to clinically severe respiratory function impairment; 13. Patients with active central nervous system metastasis; 14. Had a severe infection within 4 weeks before randomization; 15. Patients with massive or symptomatic effusions or poorly controlled effusions; 16. Imaging examination showed that the tumor had invaded or enveloped the large blood vessels in the abdomen, chest, neck, and pharynx; 17. Serious unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent; 18. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent; 19. Patients with a history of inflammatory bowel disease, extensive bowel resection, immune enteritis, intestinal obstruction or chronic diarrhea; 20. Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of BL-B01D1; 21. Had autologous or allogeneic stem cell transplantation history; 22. Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection; 23. A history of severe neurological or psychiatric illness; 24. Received other unmarketed investigational drugs or treatments within 4 weeks before randomization; 25. Subjects scheduled for vaccination or who received live vaccine within 28 days before study randomization; 26. Other circumstances in which the investigator considered it inappropriate to participate in the trial because of complications or other circumstances.