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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 550
- 试验地点
- 62
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinded Independent Central Review (BICR)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Adequate organ function
排除标准
- •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.
研究组 & 干预措施
Arm B
BL-M14D1: Administered on days 1 of every 21 days Atezolizumab: Administered dose on days 1 of every 21 days
干预措施: BL-M14D1 and Atezolizumab (Drug)
Arm A
BL-M14D1: Administered on days 1 of every 21 days Atezolizumab: Administered dose on days 1 of every 21 days
干预措施: BL-M14D1 and Atezolizumab (Drug)
Arm C
Medications used in the Control Arm should be administered per local label or institutional guidelines.
Induction therapy (4 cycles):
Carboplatin (AUC of 5 mg/mL*min IV) on Day 1 of each 21-day cycle Etoposide (100 mg/m2 IV) on Days 1 through 3 of each 21-day cycle Atezolizumab (1200 mg) IV on Day 1 of each 21-day cycle
Maintenance therapy (continues until discontinuation criteria are met):
Atezolizumab (1200 mg) IV on Day 1 of each 21-day cycle Lurbinectedin (3.2 mg/m2) IV on Day 1 of each 21-day cycle (to be added only if approved in region and as per PI discretion)
干预措施: Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin (Drug)