A Study Comparing BL-B01D1 in Combination With Osimertinib Versus Osimertinib Alone in Patients With Locally Advanced, Unresectable EGFR-mutated Non-small Cell Lung Cancer(Stage III) Whose Disease Has Not Progressed Following Definitive Platinum-based Chemoradiation Therapy(PANKU-Lung08)

Официальное название

A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 in Combination With Osimertinib Versus Osimertinib Alone in Patients With Locally Advanced, Unresectable EGFR-mutated Non-small Cell Lung Cancer(Stage III) Whose Disease Has Not Progressed Following Definitive Platinum-based Chemoradiation Therapy(PANKU-Lung08)

Обзор

This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib in patients with unresectable EGFR-mutated Stage III non-small cell lung cancer who have not progressed following platinum-based chemoradiotherapy.

Подробное описание

In this trial, the treatment group receives BL-B01D1 in combination with osimertinib, while the control group receives osimertinib monotherapy.

Вмешательства

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

Первичные конечные точки

• Progression-free survival (PFS) [Срок оценки: Up to approximately 24 months]

Вторичные конечные точки (6)

• Overall Survival (OS) [Срок оценки: Up to approximately 24 months]
• Objective Response Rate (ORR) [Срок оценки: Up to approximately 24 months]
• Disease Control Rate (DCR) [Срок оценки: Up to approximately 24 months]
• Duration of Response (DOR) [Срок оценки: Up to approximately 24 months]
• Treatment Emergent Adverse Event (TEAE) [Срок оценки: Up to approximately 24 months]
• 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 and ≤ 75 years, regardless of gender;
• Expected survival time ≥ 3 months;
• Unresectable Stage III non-small cell lung cancer;
• Detection of one of the EGFR-sensitive mutation types in tumor tissue;
• Agree to provide archived primary tumor tissue specimens or fresh tissue samples within 1 year;
• In platinum-based radical chemoradiotherapy, the platinum-containing chemotherapy regimen must include one of the specified drugs in addition to the platinum agent;
• In platinum-based radical chemoradiotherapy, patients must have received a total radiation dose of 60 Gy ± 10% before randomization;
• Toxicities from prior chemoradiotherapy must have resolved to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
• ECOG performance status score of 0 or 1;
• No severe cardiac dysfunction, with left ventricular ejection fraction ≥ 50%;
• Organ function levels must meet the requirements;
• Urine protein ≤ 1+ or < 1000 mg/24h;
• For premenopausal women with childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the test must rule out pregnancy; they must not be lactating; all enrolled trial participants must take adequate barrier contraceptive measures throughout the treatment period and for 7 months after treatment ends.

Критерии исключения

• SCLC, mixed SCLC and NSCLC, or other non-NSCLC pathological types;
• The trial participant has received other chemotherapy, radiotherapy, etc., for NSCLC apart from radical chemoradiotherapy;
• Major surgery within 4 weeks prior to the first dose;
• Prior treatment with ADC drugs using topoisomerase I inhibitors as toxins, or antibodies/ADCs targeting EGFR and/or HER3;
• History of severe heart disease or cerebrovascular disease;
• Prolonged QTc interval, complete left bundle branch block, second- or third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;
• Any thrombotic events such as deep vein thrombosis, arterial thrombosis, or pulmonary embolism within 6 months prior to screening;
• Diagnosis of active malignancy within 5 years prior to study randomization;
• Hypertension poorly controlled by two antihypertensive medications;
• Trial participants with poorly controlled blood glucose levels;
• Current radiation pneumonitis of Grade ≥2 as defined by CTCAE;
• Concurrent lung disease resulting in clinically severe respiratory impairment;
• Severe infection within 4 weeks prior to study randomization;
• Large serous cavity effusions or symptomatic serous cavity effusions;
• Imaging findings suggesting tumor invasion or encasement of major blood vessels in the abdomen, chest, neck, or pharynx;
• Severe non-healing wounds, ulcers, or fractures within 4 weeks prior to signing informed consent;
• Trial participants with clinically significant bleeding or a clear tendency for bleeding within 4 weeks prior to signing informed consent;
• Trial participants with a history of inflammatory bowel disease, extensive bowel resection, or immune-mediated enteritis;
• History of allergy to recombinant humanized antibodies or chimeric human-mouse antibodies, or allergy to any excipient components of the investigational drug;
• History of autologous or allogeneic stem cell transplantation;
• Positive for human immunodeficiency virus antibodies, active hepatitis B virus infection, or hepatitis C virus infection;
• History of severe neurological or psychiatric disorders, or a history of substance abuse, alcoholism, or drug addiction;
• Trial participants planning to receive or having received live vaccines within 28 days prior to study randomization;
• Other conditions deemed by the investigator as unsuitable for participation in this clinical trial due to complications or other reasons.

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

• Cancer Hospital of Shandong First Medical University — Цзинань

Идентификаторы

NCT: NCT07640789 · BL-B01D1-318

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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