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

Launched by SICHUAN BAILI PHARMACEUTICAL CO., LTD. · Feb 16, 2025

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ClinConnect Summary

This clinical trial is looking at a new treatment option for patients with a type of lung cancer called non-small cell lung cancer that has specific genetic changes (EGFR mutations). The study is comparing two treatments: one that includes a new medication called BL-B01D1 along with a standard treatment called osimertinib, and the other that uses osimertinib alone. The goal is to see if the combination treatment is more effective and safe for patients who have not yet received treatment for their cancer.

To participate in this trial, patients need to be at least 18 years old and have a certain type of lung cancer that cannot be surgically removed. They must also have documentation showing they have the specific genetic mutations the study is targeting. Participants will be closely monitored throughout the study and can expect regular check-ups to assess their health and the effectiveness of the treatments. It’s important to know that there are several health conditions and recent treatments that could make someone ineligible for the trial, so discussing all medical history with a healthcare provider is essential before considering participation.

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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.