A Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer(PANKU-Lung04)

Официальное название

A Phase III Randomized Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Обзор

This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib versus osimertinib as first-Line treatment in patients with EGFR-mutated locally advanced or metastatic Non-small Cell Lung Cancer.

Вмешательства

• Препарат BL-B01D1
  Administration by intravenous infusion for a cycle of 3 weeks.
• Препарат Osimertinib
  Oral administration, 80mg daily for a cycle of 3 weeks.
• Препарат Osimertinib
  Oral administration, 80mg daily for a cycle of 3 weeks.

Первичные конечные точки

• Progression-free survival (PFS) [Срок оценки: Up to approximately 36 months]

Вторичные конечные точки (6)

• Overall survival (OS) [Срок оценки: Up to approximately 36 months]
• Objective Response Rate (ORR) [Срок оценки: Up to approximately 36 months]
• Disease Control Rate (DCR) [Срок оценки: Up to approximately 36 months]
• Duration of Response (DOR) [Срок оценки: Up to approximately 36 months]
• Treatment Emergent Adverse Event (TEAE) [Срок оценки: Up to approximately 36 months]
• Anti-drug antibody (ADA) [Срок оценки: Up to approximately 36 months]

Критерии участия

Критерии включения

• Sign the informed consent form voluntarily and follow the protocol requirements;
• Age ≥18 years old;
• Expected survival time ≥3 months;
• Patients with unresectable or radical radiotherapy for locally advanced non-small cell lung cancer;
• Documentation of EGFR sensitive mutations detected from tumor tissue or blood samples;
• Consent to provide archived tumor tissue samples or fresh tissue samples of primary or metastatic lesions at or after diagnosis for testing, including EGFR mutation type;
• At least one measurable lesion meeting the RECIST v1.1 definition was required;
• ECOG 0 or 1;
• The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
• No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
• The organ function level must meet the requirements on the premise that blood transfusion and colony-stimulating factor are not allowed within 14 days before the screening period;
• Urinary protein ≤2+ or < 1000mg/24h;
• For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, serum pregnancy must be negative, and the patient must not be lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.

Критерии исключения

• Previous histologic or cytological evidence of small cell or mixed small/non-small cell components;
• Patients with previous systemic therapy;
• Patients had received EGFR-TKI therapy;
• Studies received radical radiotherapy, major surgery, and large area radiotherapy within 4 weeks before randomization;
• History of severe heart disease and cerebrovascular disease;
• Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;
• QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
• Were diagnosed with active malignancy within 3 years before randomization;
• Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \&gt; 150 mmHg or diastolic blood pressure \&gt; 100 mmHg);
• Patients with poor glycemic control;
• A history of ILD requiring steroid therapy, or current ILD or grade ≥2 radiation pneumonitis, or a suspicion of such disease;
• Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
• Patients with active central nervous system metastasis;
• Had a severe infection within 4 weeks before randomization;
• Patients with massive or symptomatic effusions or poorly controlled effusions;
• Imaging examination showed that the tumor had invaded or enveloped the large blood vessels in the abdomen, chest, neck, and pharynx;
• Serious unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent;
• Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;
• Patients with a history of inflammatory bowel disease, extensive bowel resection, immune enteritis, intestinal obstruction or chronic diarrhea;
• Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of BL-B01D1;
• Had autologous or allogeneic stem cell transplantation history;
• Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection;
• A history of severe neurological or psychiatric illness;
• Received other unmarketed investigational drugs or treatments within 4 weeks before randomization;
• Subjects scheduled for vaccination or who received live vaccine within 28 days before study randomization;
• Other circumstances in which the investigator considered it inappropriate to participate in the trial because of 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 · 1 центр

• Shanghai East Hospital — Шанхай

Идентификаторы

NCT: NCT06838273 · BL-B01D1-308

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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