NCT07642024 A Study of BL-B01D1 in Combination With Osimertinib as Perioperative Therapy in Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer(PANKU-Lung09)

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 90 participants in total. It began in 2026-07-24 with a primary completion date of 2032-12.

Brief Summary

This trial is a registrational Phase II/III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib in resectable EGFR-mutant non-small cell lung cancer.

Eligibility Criteria

Inclusion Criteria: 1. Voluntarily sign informed consent and agree to comply with the protocol requirements; 2. Aged ≥18 years and ≤75 years, regardless of gender; 3. Expected survival time ≥3 months; 4. Patients with non-small cell lung cancer; 5. One of the EGFR sensitive mutation types detected in the tumor tissue; 6. Agree to provide archived primary tumor tissue specimens obtained within 12 months or fresh tissue samples; 7. Undergo pulmonary function testing within 28 days prior to the first dose; 8. ECOG performance status score of 0 or 1; 9. No severe cardiac dysfunction; 10. Organ function levels must meet the required criteria; 11. Urine protein ≤1+ or \<1000 mg/24h; 12. For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the serum pregnancy test must exclude pregnancy; patients must not be lactating; all enrolled trial participants must use adequate barrier contraceptive measures throughout the entire treatment period and for 7 months after the end of treatment. Exclusion Criteria: 1. SCLC, mixed SCLC and NSCLC, or other non-NSCLC pathological types; 2. Trial participants who subsequently receive only segmentectomy or wedge resection; 3. Trial participants deemed surgically inoperable by the study center's surgical evaluation; 4. Undergoing major surgery within 4 weeks prior to the first dose, among others; 5. Previous receipt of systemic anti-tumor therapy for non-small cell lung cancer other than that for this study, among others; 6. Receiving long-term systemic corticosteroid therapy with prednisone \>10 mg/day within 2 weeks prior to randomization, among others; 7. History of severe heart disease or cerebrovascular disease; 8. Prolonged QTc interval, complete left bundle branch block, etc.; 9. Any thrombotic event within 6 months prior to screening; 10. Trial participants with known or suspected interstitial lung disease, among others; 11. Diagnosis of active malignant tumors within 5 years prior to study randomization; 12. Hypertension inadequately controlled by two antihypertensive medications; 13. Trial participants with poorly controlled blood glucose; 14. Severe infection occurring within 4 weeks prior to study randomization, among others; 15. Presence of large serous cavity effusion, or serous cavity effusion with symptoms, etc.; 16. Imaging findings indicating tumor invasion or encasement of the abdomen, chest, etc.; 17. Severe non-healing wounds, ulcers, or fractures within 4 weeks prior to signing informed consent; 18. Trial participants with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent; 19. Inflammatory bowel disease, history of extensive bowel resection, history of immune-related enteritis, etc.; 20. History of allergy to the investigational drug, etc.; 21. History of solid organ transplantation, autologous or allogeneic stem cell transplantation; 22. Positive for human immunodeficiency virus antibodies, active hepatitis B virus infection, or hepatitis C virus infection; 23. History of severe neurological or psychiatric disorders; 24. Trial participants planning to receive or having received live vaccines within 28 days prior to study randomization; 25. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial due to complications or other circumstances.

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