NCT07561645尚未招募2 期
A Phase II, Single-arm Trial on the Addition of the DLL3xCD3 Bispecific T-cell Engager Obrixtamig (BI 764532) to Standard-of-care Platinum-based First-line Treatment of Advanced Large-cell Neuroendocrine Carcinoma of the Lung
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 75
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This phase II clinical trial evaluates the efficacy, safety and tolerability of Obrixtamig in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •(main criteria)
- •Patient has provided written informed consent and is able to consent
- •Patients with pulmonary large-cell neuroendocrine carcinoma (LCNEC) defined by local histology and immunohistochemistry; patients with mixed histology are eligible if LCNEC is the predominant histology, i.e. ≥50%
- •Patients with locally advanced or metastatic disease without curative treatment options
- •All patients must have received one, but not more than one, cycle of platinum/etoposide chemotherapy with or without immune checkpoint inhibitor (standard-of-care; SoC). Other than that, patients must be previously untreated with systemic therapy.
- •Measurable disease according to RECIST v1.11
排除标准
- •(main criteria)
- •Symptomatic brain metastases (Patients with asymptomatic brain metastases are allowed provided they are clinically stable, receiving no or a stable dose of anticonvulsants without steroid treatment for at least 3 weeks.)
- •Known leptomeningeal disease
- •Any prior systemic treatment for metastatic disease, except for one cycle of SoC as described under inclusion criteria
- •Previous treatment with obrixtamig or any anti-DLL3 compound including T-cell engagers and antibody-drug conjugates
研究组 & 干预措施
Obrixtamig/Platinum/Etoposide
Experimental
Obrixtamig/Platinum/Etoposide. Platinum will be carboplatin.
干预措施: Obrixtamig (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: app. 69 months
To assess the efficacy of Obrixtamig in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC as measured by overall survival.
次要结局
- Objective Response Rate (ORR)(app. 69 months)
- Progression-Free Survival (PFS)(app. 69 months)
- Duration Of Response (DOR)(app. 69 months)
- Disease Control Rate (DCR)(app. 69 months)
- immune Objective Response Rate (iORR)(app. 69 months)
- immune Progression Free Survival (iPFS)(appr. 69 months)
研究者
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