A Study Comparing BL-B01D1 in Combination With PD-1/VEGF Bispecific Antibody Versus Chemotherapy in Combination With PD-1/VEGF Bispecific Antibody in First-line Patients With Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer(PANKU-Lung05)
The entire study consists of two stages, Phase II and Phase III, both of which are randomized, open-label studies.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Voluntarily sign the informed consent form and comply with the protocol requirements;
2. Age ≥18 years;
3. Expected survival time ≥3 months;
4. Patients with locally advanced or metastatic squamous non-small cell lung cancer;
5. Agree to provide tumor tissue samples obtained at or after the diagnosis of locally advanced or metastatic disease;
6. Must have at least one measurable lesion as defined by RECIST v1.1;
7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
8. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
9. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;
10. Organ function levels must meet the specified requirements;
11. Urinary protein ≤1+ or \<1000 mg/24h;
12. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with serum pregnancy test excluding pregnancy, and patients must be non-lactating; all enrolled patients (regardless of male or female) must take adequate barrier contraceptive measures throughout the entire treatment period and for 7 months after the end of treatment.
You may not be if
1. Prior histological or cytological evidence of small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components;
2. Indications of the presence of EGFR-sensitive mutations, among others;
3. Patients who have received prior systemic therapy;
4. Prior treatment with agents targeting the mechanism of tumor immune action;
5. Prior treatment with ADC drugs that use topoisomerase I inhibitors as the toxin, among others;
6. Receipt of radical radiotherapy, major surgery, or large-field radiotherapy within 4 weeks before study randomization;
7. History of severe heart disease or cerebrovascular disease;
8. Receipt of long-term systemic corticosteroid therapy (e.g., prednisone \>10 mg/day) before the first dose;
9. Active autoimmune diseases and inflammatory diseases requiring systemic treatment within 2 years;
10. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
11. Prolonged QTc interval, complete left bundle branch block, among others;
12. Diagnosis of active malignancy within 3 years before study randomization;
13. Hypertension inadequately controlled by two antihypertensive medications;
14. Patients with poorly controlled blood glucose levels;
15. History of ILD requiring steroid therapy, current ILD, or grade ≥2 radiation pneumonitis, among others;
16. Pulmonary diseases leading to clinically severe impairment of respiratory function;
17. Patients with active central nervous system metastases;
18. Severe infection occurring within 4 weeks before study randomization;
19. Presence of large serous cavity effusions or symptomatic serous cavity effusions, among others;
20. Imaging findings indicating tumor invasion or encasement of the abdomen, chest, etc.;
21. Severe non-healing wounds, ulcers, or fractures within 4 weeks before signing informed consent;
22. Trial participants with clinically significant bleeding or a significant bleeding tendency within 4 weeks prior to signing informed consent;
23. Patients with inflammatory bowel disease, history of extensive bowel resection, history of immune enteritis, intestinal obstruction, or chronic diarrhea, among others;
24. History of allergy to recombinant humanized antibodies or hypersensitivity to any excipient of BL-B01D1;
25. History of autologous or allogeneic stem cell transplantation;
26. Positive for human immunodeficiency virus antibody, active hepatitis B virus infection, or hepatitis C virus infection;
27. History of severe neurological or psychiatric disorders;
28. Receipt of other unapproved clinical study drugs or treatments within 4 weeks before study randomization;
29. Trial participants planning to receive or having received live vaccines within 28 days before study randomization;
30. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial due to complications or other circumstances.
Clareo Health | A Study Comparing BL-B01D1 in Combination With PD-1/VEGF Bispecific Antibody Versus Chemotherapy in Combination With PD-1/VEGF Bispecific Antibody in First-line Patients With Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer(PANKU-Lung05)
