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)

Official record

Identifier

NCT07739186

Recruiting locations

country

China

Interventions studied

BL-B01D1PD-1/VEGF Bispecific AntibodyTislelizumabPemetrexedCarboplatinCisplatin

Lead sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Target enrolment

120 participants

Study type

INTERVENTIONAL

Phase

Phase 2/3

Status

Not yet recruiting

First posted

Jul 31, 2026

Last updated on the registry

Jul 31, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.

Indexed under

Lung Cancer