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

Exclusion Criteria26

• Previous histologic or cytological evidence of small cell or mixed small/non-small cell components;
• Patients with previous systemic therapy;
• Patients had received EGFR-TKI therapy;
• Studies received radical radiotherapy, major surgery, and large area radiotherapy within 4 weeks before randomization;
• History of severe heart disease and cerebrovascular disease;
• Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;
• QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
• Were diagnosed with active malignancy within 3 years before randomization;
• Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg);
• Patients with poor glycemic control;
• A history of ILD requiring steroid therapy, or current ILD or grade ≥2 radiation pneumonitis, or a suspicion of such disease;
• Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
• Patients with active central nervous system metastasis;
• Had a severe infection within 4 weeks before randomization;
• Patients with massive or symptomatic effusions or poorly controlled effusions;
• Imaging examination showed that the tumor had invaded or enveloped the large blood vessels in the abdomen, chest, neck, and pharynx;
• Serious unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent;
• Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;
• Patients with a history of inflammatory bowel disease, extensive bowel resection, immune enteritis, intestinal obstruction or chronic diarrhea;
• Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of BL-B01D1;
• Had autologous or allogeneic stem cell transplantation history;
• Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection;
• A history of severe neurological or psychiatric illness;
• Received other unmarketed investigational drugs or treatments within 4 weeks before randomization;
• Subjects scheduled for vaccination or who received live vaccine within 28 days before study randomization;
• Other circumstances in which the investigator considered it inappropriate to participate in the trial because of complications or other circumstances.