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)

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

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.

Conditions3

Interventions5

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