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)

Официальное название

A Phase II/III Clinical 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)

Обзор

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.

Подробное описание

The entire study consists of two stages, Phase II and Phase III, both of which are randomized, open-label studies.

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 Paclitaxel
  Administration by intravenous infusion for a cycle of 3 weeks.
• Препарат Carboplatin
  Administration by intravenous infusion for a cycle of 3 weeks.

Первичные конечные точки

• Phase II: Investigator-assessed 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]

Вторичные конечные точки (12)

• Phase II/III:Treatment Emergent Adverse Event (TEAE) [Срок оценки: Up to approximately 24 months]
• Phase II/III: Progression-free Survival (PFS) [Срок оценки: Up to approximately 24 months]
• Phase II/III: Objective Response Rate (ORR) [Срок оценки: Up to approximately 24 months]
• 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: Cmax [Срок оценки: Up to approximately 24 months]
• Phase II/III: Tmax [Срок оценки: Up to approximately 24 months]
• Phase II/III: T1/2 [Срок оценки: Up to approximately 24 months]
• Phase II/III: AUC0-t [Срок оценки: Up to approximately 24 months]
• Phase II/III: CL (Clearance) [Срок оценки: Up to approximately 24 months]
• Phase II/III: Ctrough [Срок оценки: Up to approximately 24 months]
• Phase II/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 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.

Критерии исключения

• 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;
• 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 clinical study drugs or treatments within 4 weeks before study randomization;
• Trial participants planning to receive or having received live vaccines within 28 days before study randomization;
• Other conditions deemed by the investigator as 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
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Ухань

Идентификаторы

NCT: NCT07739199 · BL-B01D1-312

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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