Tests BL-B01D1 with osimertinib as first treatment for lung cancer

Who can take part

• Sign the informed consent form voluntarily and follow the protocol requirements
• Age ≥18 years old
• Expected survival time ≥3 months
• Patients with unresectable or radical radiotherapy for locally advanced non-small cell lung cancer
• Documentation of EGFR sensitive mutations detected from tumor tissue or blood samples
• 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
• At least one measurable lesion meeting the RECIST v1.1 definition was required
• ECOG 0 or 1
• The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0
• No severe cardiac dysfunction, left ventricular ejection fraction ≥50%
• 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
• Urinary protein ≤2+ or < 1000mg/24h
• 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

Who cannot take part

• Previous histologic or cytological evidence of small cell or mixed small/non-small cell components
• Patients with previous systemic therapy
• Studies received radical radiotherapy, major surgery, and large area radiotherapy within 4 weeks before randomization
• Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded
• Had a severe infection within 4 weeks before randomization
• 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
• Had autologous or allogeneic stem cell transplantation history
• 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
• History of severe heart disease and cerebrovascular disease
• Were diagnosed with active malignancy within 3 years before randomization
• Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \&gt; 150 mmHg or diastolic blood pressure \&gt; 100 mmHg)
• 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 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
• Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection
• A history of severe neurological or psychiatric illness
• Patients had received EGFR-TKI therapy
• QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia
• Patients with poor glycemic control
• Patients with active central nervous system metastasis
• 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
• Other circumstances in which the investigator considered it inappropriate to participate in the trial because of complications or other circumstances