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)

Официальное название

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)

Обзор

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.

Вмешательства

• Препарат BL-B01D1
  Administration by intravenous infusion for a cycle of 3 weeks.
• Препарат PD-1/VEGF Bispecific Antibody
  Administration by intravenous infusion for a cycle of 3 weeks.
• Препарат Tislelizumab
  Administration by intravenous infusion for a cycle of 3 weeks.
• Препарат Pemetrexed
  Administration by intravenous infusion for a cycle of 3 weeks.
• Препарат Carboplatin
  Administration by intravenous infusion for a cycle of 3 weeks.
• Препарат Cisplatin
  Administration by intravenous infusion for a cycle of 3 weeks.

Первичные конечные точки

• Phase II: Objective Response Rate (ORR) [Срок оценки: Up to approximately 24 months]
• Phase II: Investigator-assessed Progression-free Survival (PFS) [Срок оценки: Up to approximately 24 months]
• Phase III: BICR-assessed Progression-free Survival (PFS) [Срок оценки: Up to approximately 24 months]
• Phase III: Overall Survival (OS) [Срок оценки: Up to approximately 24 months]

Вторичные конечные точки (12)

• Phase II/III: Disease Control Rate (DCR) [Срок оценки: Up to approximately 24 months]
• Phase II/III: Duration of Response (DOR) [Срок оценки: Up to approximately 24 months]
• Phase II/III: Treatment Emergent Adverse Event (TEAE) [Срок оценки: Up to approximately 24 months]
• Phase III: Progression-free Survival (PFS) [Срок оценки: Up to approximately 24 months]
• Phase III: BICR and Investigator-assessed Objective Response Rate (ORR) [Срок оценки: Up to approximately 24 months]
• Phase III: Cmax [Срок оценки: Up to approximately 24 months]
• Phase III: Tmax [Срок оценки: Up to approximately 24 months]
• Phase III: T1/2 [Срок оценки: Up to approximately 24 months]
• Phase III: AUC0-t [Срок оценки: Up to approximately 24 months]
• Phase III: CL (Clearance) [Срок оценки: Up to approximately 24 months]
• Phase III: Ctrough [Срок оценки: Up to approximately 24 months]
• Phase III: Anti-drug Antibody (ADA) [Срок оценки: Up to approximately 24 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Presence of small cell lung cancer, neuroendocrine carcinoma, sarcomatoid carcinoma components, or squamous carcinoma components exceeding 10%;
• Evidence suggesting the presence of EGFR-sensitive mutations, etc.;
• 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;
• History of severe cardiac or cerebrovascular disease;
• Receiving long-term systemic corticosteroid therapy (e.g., >10 mg/day prednisone) prior to the first dose;
• Active autoimmune diseases and inflammatory diseases;
• Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
• Prolonged QT interval, complete left bundle branch block, etc.;
• Diagnosis of active malignancy within 3 years before study randomization;
• Hypertension poorly controlled by two antihypertensive medications;
• Patients with poorly controlled blood glucose;
• History of ILD requiring steroid therapy, current ILD, or ≥ grade 2 radiation pneumonitis, etc.;
• Concurrent pulmonary diseases resulting in clinically severe impairment of respiratory function;
• Patients with active central nervous system metastases;
• Occurrence of severe infection within 4 weeks before study randomization;
• 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;
• 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;
• Patients with a history of inflammatory bowel disease, extensive bowel resection, immune-mediated enteritis, intestinal obstruction, or chronic diarrhea, etc.;
• History of allergy to recombinant humanized antibodies or allergy to the investigational drug, 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;
• 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;
• Other conditions that, in the investigator's opinion, make the patient unsuitable for participation in this clinical trial due to complications or other circumstances.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Sun Yat-sen University Cancer Center — Гуанчжоу
• The First Affiliated Hospital of Guangzhou Medical University — Гуанчжоу

Идентификаторы

NCT: NCT07739186 · BL-B01D1-313

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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