BL-B01D1 With a Bispecific Antibody for First Treatment of Non-squamous Lung Cancer
Tests BL-B01D1 plus a bispecific antibody in adults with advanced non-squamous non-small cell lung cancer.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Guangzhou, ChinaSee the 2 sites
- Phase
- Phase 2/3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with non-squamous non-small cell lung cancer that has spread locally or to other parts of the body, who have not yet had drug treatment for it.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Locally advanced or metastatic non-squamous non-small cell lung cancer, with at least one measurable tumor lesion (RECIST v1.1)
- Earlier treatment
- No earlier systemic therapy. No earlier immune therapy, anti-angiogenic therapy, or antibody-drug conjugate with a topoisomerase I inhibitor toxin.
- Biomarker or test result
- Evidence of EGFR-sensitive mutations is an exclusion. Tumor tissue samples must be provided.
Main reasons for not taking part
- Small cell, neuroendocrine or sarcomatoid components, or squamous components above 10%
- Active metastases in the central nervous system
- Interstitial lung disease or lung disease that severely impairs breathing
- Active autoimmune disease or severe heart or brain blood vessel disease
- Positive for HIV antibody, or active hepatitis B or hepatitis C infection
Read by machine on 9 November 2026.
Where in China
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaNo longer taking part
- The First Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Sichuan Baili Pharmaceutical Co., Ltd.
- Trial code
- NCT07739186
- Record updated
- 28 October 2026
- Original description
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.Read full original descriptionShow less
A Randomized, Open-label, Multicenter Phase II/III Clinical 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)
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.
Inclusion: Voluntarily sign the informed consent form and comply with the protocol requirements; Age ≥ 18 years; Expected survival time ≥ 3 months; Patients with locally advanced non-squamous non-small cell lung cancer; Agree to provide tumor tissue samples obtained at or after diagnosis of locally advanced or metastatic cancer; Must have at least one measurable lesion as defined by RECIST v1.1; ECOG performance status score of 0 or 1; Toxicities from prior anti-tumor therapy have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0; No severe cardiac dysfunction, with left ventricular ejection fraction ≥ 50%; Organ function levels must meet the required criteria; Urinary protein ≤ 2+ or < 1000 mg/24h; 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: Patients who have received prior systemic therapy; Prior receipt of therapies targeting the mechanism of tumor immunity; Prior receipt of antibody-drug conjugates (ADCs) using topoisomerase I inhibitors as the toxin, etc; Trial participants who have received prior systemic anti-angiogenic therapy; Receipt of radical radiotherapy, major surgery, or large-field radiotherapy within 4 weeks before study randomization; Receiving long-term systemic corticosteroid therapy (e.g., >10 mg/day prednisone) prior to the first dose; Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Concurrent pulmonary diseases resulting in clinically severe impairment of respiratory function; Occurrence of severe infection within 4 weeks before study randomization; Presence of serious non-healing wounds, ulcers, or fractures within 4 weeks before signing informed consent; Trial participants with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing informed consent; History of allergy to recombinant humanized antibodies or allergy to the investigational drug, etc; Receipt of other unapproved investigational drugs or treatments within 4 weeks before study randomization; Trial participants who plan to receive or have received live vaccines within 28 days before study randomization; Presence of small cell lung cancer, neuroendocrine carcinoma, sarcomatoid carcinoma components, or squamous carcinoma components exceeding 10%; History of severe cardiac or cerebrovascular disease; Active autoimmune diseases and inflammatory diseases; Diagnosis of active malignancy within 3 years before study randomization; Hypertension poorly controlled by two antihypertensive medications; History of ILD requiring steroid therapy, current ILD, or ≥ grade 2 radiation pneumonitis, etc; Patients with a history of inflammatory bowel disease, extensive bowel resection, immune-mediated enteritis, intestinal obstruction, or chronic diarrhea, etc; History of autologous or allogeneic stem cell transplantation; Positive for human immunodeficiency virus antibody, active hepatitis B virus infection, or hepatitis C virus infection; History of severe neurological or psychiatric disorders; Other conditions that, in the investigator's opinion, make the patient unsuitable for participation in this clinical trial due to complications or other circumstances; Evidence suggesting the presence of EGFR-sensitive mutations, etc; Prolonged QT interval, complete left bundle branch block, etc; Patients with poorly controlled blood glucose; Patients with active central nervous system metastases; Presence of large serous cavity effusions, or symptomatic serous cavity effusions, etc; Imaging findings suggesting tumor invasion or encasement of abdominal, thoracic, or other regions.