jRCT2071250006尚未招募不适用
A Global, Multicer, Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Standard of Care (SOC) in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (ES-SCLC)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 695
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
入选标准
- •Histologically confirmed diagnosis of SCLC.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or
- •Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by investigator per RECIST v1.1 criteria.
- •Documentation of radiological disease progression after 1 prior line of platinum-containing chemotherapy (defined as at least 2 cycles of treatment) with or without therapy directed against programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1; PD-1 and PD-L1 are hereafter referred to as PD-(L)1) for ES-SCLC.
排除标准
- •Chemotherapy-free interval (CTFI) time from the last dose of first-line platinum-containing chemotherapy to the occurrence of progressive disease) < 30 days (independent of the immunotherapy maintenance).
- •Received any prior treatment with irinotecan, topotecan, SG, SN-38, exatecan derivatives, and similar agents targeting topoisomerase I.
- •Untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they have stable CNS disease (ie, without evidence of progression) for at least 4 weeks prior to enrollment and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking <= 10 mg/day of prednisone or its equivalent.
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to 4.5 years
ORR is defined as the percentage of participants who have achieved a complete response (CR) or partial response (PR) as assessed by BICR according to RECIST v1.1.
Overall Survival (OS)
时间窗: Up to 4.5 years
OS is defined as length of time from randomization until the date of death from any cause.
次要结局
- Progression-free Survival (PFS)(Up to 4.5 years)
- Duration of Response (DOR)(Up to 4.5 years)
- Time to First Deterioration in Shortness of Breath Domain(Up to 4.5 years)
- Time to First Deterioration in Physical Functioning Domain(Up to 4.5 years)
- Percentage of Participants Experiencing Clinical Laboratory abnormalities(First dose date up to 4.5 years)
- Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)(First dose date up to 4.5 years)
研究者
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