NCT07218146招募中3 期
A Randomized, Open-Label, Phase 3 Study of ZL-1310, a DLL3 Antibody-Drug Conjugate (ADC), Compared to Investigator's Choice Therapy in Participants With Relapsed Small Cell Lung Cancer
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 480
- 试验地点
- 266
- 主要终点
- Confirmed objective response rate (ORR) assessed by Blinded Independent Central Review of ZL-1310 compared to Investigator's Choice Therapy (ICT)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of ZL-1310 compared to Investigator's Choice Therapy in participants with relapsed Small Cell Lung Cancer.
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
- 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
- •Age >/= 18 years, or considered an adult by local regulations, at the time of consent
- •Signed informed consent
- •Histologically or cytologically confirmed SCLC. Received 1L platinum-based systemic therapy and had documented disease progression during or after the most recent systemic therapy. Or received 2L tarlatamab is allowed.
- •Measurable disease according to RECIST v1.1 as assessed by the investigator.
- •Participants with a history of treated and stable or untreated and asymptomatic CNS metastases based on criteria per protocol.
- •Adequate organ and marrow function
- •Eastern Cooperative Group (ECOG) performance status of 0 or 1
- •Life expectancy of at least 3 months
- •Participants must be willing to undergo a tumor biopsy or provide archived tumor tissue sample at Screening
- •Participants must be willing and able to comply with protocol for the duration of the study
排除标准
- •Received more than one line of systemic therapy for Extensive-Stage SCLC.
- •Received any prior ADC with topoisomerase 1 inhibitor payload
- •Participants with another known malignancy with exceptions defined in the protocol.
- •History or suspected ILD/pneumonitis based on criteria per protocol
- •Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.
- •Receipt of anti-cancer treatment known to treat cancers within 3 weeks before the first dose of study treatment.
- •Prior radiotherapy before study treatment based on criteria per protocol
- •Unresolved toxicity of Grade >/= 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation.
- •Known infection or active infection defined in the protocol.
- •Clinically significant active cardiovascular disease or history of arterial thromboembolic event within 6 months prior to the first dose of study treatment based on criteria per protocol.
研究组 & 干预措施
Arm 2
Active Comparator
Investigator's Choice of Therapy
干预措施: Investigator's Choice of Therapy (Drug)
Arm 1
Experimental
ZL-1310 as a single agent
干预措施: ZL-1310 (Drug)
结局指标
主要结局
Confirmed objective response rate (ORR) assessed by Blinded Independent Central Review of ZL-1310 compared to Investigator's Choice Therapy (ICT)
时间窗: up to 30 months
Overall survival of ZL-1310 compared to Investigator's Choice Therapy (ICT)
时间窗: up to 30 months
Confirmed objective response rate (ORR) assessed by Blinded Independent Central Review of ZL-1310 compared to Investigator's Choice Therapy (ICT)
时间窗: up to 27 months
Overall survival of ZL-1310 compared to Investigator's Choice Therapy (ICT)
时间窗: up to 27 months
次要结局
- Duration of response (DoR) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT)(up to 30 months)
- Progression-free survival (PFS) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT)(up to 30 months)
- Confirmed ORR assessed by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT)(up to 30 months)
- Time to response (TTR) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT)(up to 30 months)
- Confirmed CNS response assessed by BICR per Response Assessment in Neuro-Oncology for Brain Metastases (RANO-BM) of ZL-1310 compared to Investigator's Choice Therapy (ICT)(up to 30 months)
- Occurrence of treatment-emergent adverse events (TEAEs) of ZL-1310 compared to Investigator's Choice Therapy (ICT)(up to 30 months)
- Changes from baseline in quality of life related parameters of ZL-1310 compared to Investigator's Choice Therapy (ICT) using EQ-5D-5L(up to 30 months)
- Changes from baseline in quality of life related parameters of ZL-1310 compared to Investigator's Choice Therapy (ICT) using EORTC-QLQ-C30(up to 30 months)
- Changes from baseline in quality of life related parameters of ZL-1310 compared to Investigator's Choice Therapy (ICT) using EORTC-QLQ-LC13(up to 30 months)
- Duration of response (DoR) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT)(up to 27 months)
- Progression-free survival (PFS) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT)(up to 27 months)
- Confirmed ORR assessed by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT)(up to 27 months)
- Time to response (TTR) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT)(up to 27 months)
- Confirmed CNS response assessed by BICR per Response Assessment in Neuro-Oncology for Brain Metastases (RANO-BM) of ZL-1310 compared to Investigator's Choice Therapy (ICT)(up to 27 months)
- Occurrence of treatment-emergent adverse events (TEAEs) of ZL-1310 compared to Investigator's Choice Therapy (ICT)(up to 27 months)
- Changes from baseline in quality of life related parameters of ZL-1310 compared to Investigator's Choice Therapy (ICT) using EQ-5D-5L(up to 27 months)
- Changes from baseline in quality of life related parameters of ZL-1310 compared to Investigator's Choice Therapy (ICT) using EORTC-QLQ-C30(up to 27 months)
- Changes from baseline in quality of life related parameters of ZL-1310 compared to Investigator's Choice Therapy (ICT) using EORTC-QLQ-LC13(up to 27 months)
研究者
研究点 (266)
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