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

Conditions: Non-small Cell Lung Cancer

Summary: 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.


Eligibility criteria:
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.