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)

Korábbi kezelés

• 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;

Más betegség

• 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.

Laborértékek

• Evidence suggesting the presence of EGFR-sensitive mutations, etc.;
• Prolonged QT interval, complete left bundle branch block, etc.;
• Patients with poorly controlled blood glucose;

Egyéb

• 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;

• 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.