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A Study Evaluating BL-B01D1 in Combination With a PD-1/VEGF Bispecific Antibody Versus Tislelizumab Plus Platinum-doublet Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer(PANKU-Lung06)
A Study Evaluating BL-B01D1 in Combination With a PD-1/VEGF Bispecific Antibody Versus Tislelizumab Plus Platinum-doublet Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer(PANKU-Lung06)

NCT07739186

Not Yet RecruitingPhase 2, Phase 3

Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

Conditions: Non-squamous Non-small Cell Lung Cancer

Interventions: BL-B01D1, PD-1/VEGF Bispecific Antibody, Tislelizumab, Pemetrexed, Carboplatin

Countries: China

This trial is a registrational randomized, open-label, multicenter Phase II/III study designed to evaluate the efficacy and safety of BL-B01D1 in combination with a PD-1/VEGF bispecific antibody in patients with locally advanced or metastatic non-squamous non-small cell lung cancer.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

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 non-squamous non-small cell lung cancer;
5. Agree to provide tumor tissue samples obtained at or after diagnosis of locally advanced or metastatic cancer;
6. Must have at least one measurable lesion as defined by RECIST v1.1;
7. ECOG performance status score of 0 or 1;
8. Toxicities from prior anti-tumor therapy 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 required criteria;
11. Urinary protein ≤ 2+ or \< 1000 mg/24h;
12. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment; serum pregnancy test must rule out pregnancy; patients must be non-lactating and must use highly effective contraceptive measures throughout the treatment period and for 7 months after the last dose. For male participants whose partners are women of childbearing potential, adequate barrier contraceptive measures must be used throughout the treatment period and for 7 months after the end of treatment.

Exclusion Criteria:

1. Presence of small cell lung cancer, neuroendocrine carcinoma, sarcomatoid carcinoma components, or squamous carcinoma components exceeding 10%;
2. Evidence suggesting the presence of EGFR-sensitive mutations, etc.;
3. Patients who have received prior systemic therapy;
4. Prior receipt of therapies targeting the mechanism of tumor immunity;
5. Prior receipt of antibody-drug conjugates (ADCs) using topoisomerase I inhibitors as the toxin, etc.;
6. Trial participants who have received prior systemic anti-angiogenic therapy;
7. Receipt of radical radiotherapy, major surgery, or large-field radiotherapy within 4 weeks before study randomization;
8. History of severe cardiac or cerebrovascular disease;
9. Receiving long-term systemic corticosteroid therapy (e.g., \>10 mg/day prednisone) prior to the first dose;
10. Active autoimmune diseases and inflammatory diseases;
11. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
12. Prolonged QT interval, complete left bundle branch block, etc.;
13. Diagnosis of active malignancy within 3 years before study randomization;
14. Hypertension poorly controlled by two antihypertensive medications;
15. Patients with poorly controlled blood glucose;
16. History of ILD requiring steroid therapy, current ILD, or ≥ grade 2 radiation pneumonitis, etc.;
17. Concurrent pulmonary diseases resulting in clinically severe impairment of respiratory function;
18. Patients with active central nervous system metastases;
19. Occurrence of severe infection within 4 weeks before study randomization;
20. Presence of large serous cavity effusions, or symptomatic serous cavity effusions, etc.;
21. Imaging findings suggesting tumor invasion or encasement of abdominal, thoracic, or other regions;
22. Presence of serious non-healing wounds, ulcers, or fractures within 4 weeks before signing informed consent;
23. Trial participants with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing informed consent;
24. Patients with a history of inflammatory bowel disease, extensive bowel resection, immune-mediated enteritis, intestinal obstruction, or chronic diarrhea, etc.;
25. History of allergy to recombinant humanized antibodies or allergy to the investigational drug, etc.;
26. History of autologous or allogeneic stem cell transplantation;
27. Positive for human immunodeficiency virus antibody, active hepatitis B virus infection, or hepatitis C virus infection;
28. History of severe neurological or psychiatric disorders;
29. Receipt of other unapproved investigational drugs or treatments within 4 weeks before study randomization;
30. Trial participants who plan to receive or have received live vaccines within 28 days before study randomization;
31. Other conditions that, in the investigator's opinion, make the patient unsuitable for participation in this clinical trial due to complications or other circumstances.
Locations (2)
  • Guangzhou, Guangdong, China
  • Guangzhou, Guangdong, China