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)

Starting soon · Phase 2/Phase 3

Conditions studied: Squamous Non-small-cell Lung Cancer

In brief

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

Key facts

Study ID

NCT07739199

Run by

Sichuan Baili Pharmaceutical Co., Ltd.

People needed

200

Starts

2026-08-01

Expected to finish

2029-12-01

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Voluntarily sign the informed consent form and comply with the protocol requirements;
• Age ≥18 years;
• Expected survival time ≥3 months;
• Patients with locally advanced or metastatic squamous non-small cell lung cancer;
• Agree to provide tumor tissue samples obtained at or after the diagnosis of locally advanced or metastatic disease;
• Must have at least one measurable lesion as defined by RECIST v1.1;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
• Toxicities from prior anti-tumor therapy must 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 specified requirements;
• Urinary protein ≤1+ or <1000 mg/24h;
• 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 qualify if…

• Prior histological or cytological evidence of small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components;
• Indications of the presence of EGFR-sensitive mutations, among others;
• Patients who have received prior systemic therapy;
• Prior treatment with agents targeting the mechanism of tumor immune action;
• Prior treatment with ADC drugs that use topoisomerase I inhibitors as the toxin, among others;
• Receipt of radical radiotherapy, major surgery, or large-field radiotherapy within 4 weeks before study randomization;
• History of severe heart disease or cerebrovascular disease;
• Receipt of long-term systemic corticosteroid therapy (e.g., prednisone >10 mg/day) before the first dose;
• Active autoimmune diseases and inflammatory diseases requiring systemic treatment within 2 years;
• Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
• Prolonged QTc interval, complete left bundle branch block, among others;
• Diagnosis of active malignancy within 3 years before study randomization;
• Hypertension inadequately controlled by two antihypertensive medications;
• Patients with poorly controlled blood glucose levels;
• History of ILD requiring steroid therapy, current ILD, or grade ≥2 radiation pneumonitis, among others;
• Pulmonary diseases leading to clinically severe impairment of respiratory function;
• Patients with active central nervous system metastases;
• Severe infection occurring within 4 weeks before study randomization;
• Presence of large serous cavity effusions or symptomatic serous cavity effusions, among others;
• Imaging findings indicating tumor invasion or encasement of the abdomen, chest, etc.;
• Severe non-healing wounds, ulcers, or fractures within 4 weeks before signing informed consent;
• Trial participants with clinically significant bleeding or a significant bleeding tendency within 4 weeks prior to signing informed consent;
• Patients with inflammatory bowel disease, history of extensive bowel resection, history of immune enteritis, intestinal obstruction, or chronic diarrhea, among others;
• History of allergy to recombinant humanized antibodies or hypersensitivity to any excipient of BL-B01D1;
• History of autologous or allogeneic stem cell transplantation;

Where it is running

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China

Full record on ClinicalTrials.gov

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