BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01)

Официальное название

A Phase 3 Open-Label, Randomized Controlled Trial of BL-M14D1 and Atezolizumab vs. Standard-of-Care Therapy in Patients With First-Line Extensive-Stage Small Cell Lung Cancer

Обзор

The objective of the study is to evaluate the efficacy and safety of BL-M14D1 in combination with Atezolizumab compared to Standard-of-Care Therapy in adult participants with previously untreated extensive-stage small cell lung cancer (ES-SCLC).

Подробное описание

This study is a Global Phase 3, open-label, multicenter study designed to evaluate the efficacy and safety of BL-M14D1 in combination with atezolizumab compared with standard-of-care therapy in adult participants with previously untreated extensive-stage small cell lung cancer (ES-SCLC). Standard-of-care therapy consists of carboplatin plus etoposide chemotherapy and atezolizumab, followed by maintenance treatment with atezolizumab with or without lurbinectedin.

Вмешательства

• Препарат BL-M14D1 and Atezolizumab
  BL-M14D1 administered in combination with atezolizumab. BL-M14D1 will be given intravenously at the protocol-specified dose and schedule. Atezolizumab will be administered intravenously according to the approved dosing regimen.
• Препарат Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin
  Carboplatin and etoposide will be administered intravenously in combination with atezolizumab for induction therapy, followed by maintenance treatment with atezolizumab with or without lurbinectedin per protocol.

Первичные конечные точки

• Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR) [Срок оценки: Up to approximately 2 years]

Вторичные конечные точки (11)

• Overall Survival (OS) [Срок оценки: Up to approximately 2 years]
• Participants with Serious Adverse Events (SAEs) [Срок оценки: Up to approximately 5 years]
• Participants with treatment-emergent adverse events (TEAEs) [Срок оценки: Up to approximately 5 years]
• Evaluate the safety of BL-M14D1 in combination with atezolizumab [Срок оценки: Up to approximately 5 years]
• Participants with abnormal lab results [Срок оценки: Up to approximately 5 years]
• To compare and quantify the impact of BL-M14D1 in combination with atezolizumab on participants' quality of life and functional status [Срок оценки: Up to 5 years]
• Overall Response Rate (ORR) [Срок оценки: Up to 5 years]
• Disease Control Rate (DCR) [Срок оценки: Up to 5 years]
• Duration Of Response (DOR) [Срок оценки: Up to 5 years]
• Time To Response (TTR) [Срок оценки: Up to 5 years]
• Progression Free Survival (PFS) [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

• Histologically or cytologically confirmed first-line (1L), extensive-stage (ES) small cell lung cancer (SCLC)
• Must be eligible to receive a platinum-based chemotherapy regimen in combination with an anti-PD-L1 inhibitor.
• At least one measurable lesion based on RECIST v1.1 per investigator assessment.
• An Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1.
• Adequate organ function

Критерии исключения

• Received any kind of platinum or etoposide treatment for limited stage (LS) SCLC within 6 months prior to enrollment.
• Participants who have received prior topoisomerase inhibitor-based ADC therapy.
• Participants with history of severe heart disease
• Participants with active autoimmune diseases and inflammatory diseases,
• Participants with other prior or concurrent malignancies except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situ after adequate resection, or other malignancy treated with curative intent with a disease-free interval of at least 3 years
• Other protocol-defined inclusion/exclusion criteria apply.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07625644 · BL-M14D1-LC-301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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