A Study Comparing BL-B01D1 in Combination With PD-1/VEGF Bispecific Antibody Versus Chemotherapy in Combination With PD-1/VEGF Bispecific Antibody in First-line Patients With Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer(PANKU-Lung05)

This trial is a registrational Phase II/III randomized, open-label, multicenter study designed to evaluate the efficacy and safety of BL-B01D1 in combination with PD-1/VEGF bispecific antibody in first-line patients with locally advanced or metastatic squamous non-small cell lung cancer.

Inclusion Criteria: 1. Voluntarily sign the informed consent form and comply with the protocol requirements; 2. Age ≥18 years; 3. Expected survival time ≥3 months; 4. Patients with locally advanced or metastatic squamous non-small cell lung cancer; 5. Agree to provide tumor tissue samples obtained at or after the diagnosis of locally advanced or metastatic disease; 6. Must have at least one measurable lesion as defined by RECIST v1.1; 7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 8. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0; 9. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%; 10. Organ function levels must meet the specified requirements; 11. Urinary protein ≤1+ or \10 mg/day) before the first dose; 9. Active autoimmune diseases and inflammatory diseases requiring systemic treatment within 2 years; 10. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; 11. Prolonged QTc interval, complete left bundle branch block, among others; 12. Diagnosis of active malignancy within 3 years before study randomization; 13. Hypertension inadequately controlled by two antihypertensive medications; 14. Patients with poorly controlled blood glucose levels; 15. History of ILD requiring steroid therapy, current ILD, or grade ≥2 radiation pneumonitis, among others; 16. Pulmonary diseases leading to clinically severe impairment of respiratory function; 17. Patients with active central nervous system metastases; 18. Severe infection occurring within 4 weeks before study randomization; 19. Presence of large serous cavity effusions or symptomatic serous cavity effusions, among others; 20. Imaging findings indicating tumor invasion or encasement of the abdomen, chest, etc.; 21. Severe non-healing wounds, ulcers, or fractures within 4 weeks before signing informed consent; 22. Trial participants with clinically significant bleeding or a significant bleeding tendency within 4 weeks prior to signing informed consent; 23. Patients with inflammatory bowel disease, history of extensive bowel resection, history of immune enteritis, intestinal obstruction, or chronic diarrhea, among others; 24. History of allergy to recombinant humanized antibodies or hypersensitivity to any excipient of BL-B01D1; 25. History of autologous or allogeneic stem cell transplantation; 26. Positive for human immunodeficiency virus antibody, active hepatitis B virus infection, or hepatitis C virus infection; 27. History of severe neurological or psychiatric disorders; 28. Receipt of other unapproved clinical study drugs or treatments within 4 weeks before study randomization; 29. Trial participants planning to receive or having received live vaccines within 28 days before study randomization; 30. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial due to complications or other circumstances.