NCT07796100尚未招募3 期
A Randomized, Open-Label, Phase 3 Study of ZL-1310, a DLL3 Antibody-drug Conjugate (ADC) in Combination With a Checkpoint Inhibitor Compared to Standard of Care Platinum Based Chemotherapy With a Checkpoint Inhibitor as First-line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 530
- 主要终点
- Overall survival of ZL-1310 with IO compared to chemo with IO
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of ZL-1310 in combination with a checkpoint inhibitor compared to standard first-line therapy in participants with Extensive-Stage 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
- •Histologically or cytologically confirmed ES-SCLC
- •No prior systemic therapy has been received
- •Medically eligible to receive standard platinum-based chemotherapy with atezolizumab or durvalumab as first-line therapy
- •Eastern Cooperative Oncology Group performance status of 0 or 1
- •Life expectancy of at least 3 months
- •Adequate organ and marrow function
排除标准
- •Has a contraindication to receive atezolizumab or durvalumab according to local drug label or local treatment guideline
- •Participants with symptomatic CNS metastases (require initiation or dose change of steroids or anti-convulsant within 7 days prior to randomization; require steroid dose higher that prednisone 10 mg/day or equivalent within 14 days prior to randomization
- •History of ILD/pnuemonitis (non-infectious) that required corticosteroids, current ILD/pnuemonitis of any grade, or suspected ILD/pnuemonitis that cannot be ruled out by imaging at screening
- •Received radiotherapy within 2 weeks to the non-thoracic and within 4 weeks to the thoracic area prior to the first dose of study treatment or received more than 30 Gy of thoracic radiotherapy
- •Clinically significant active cardiovascular disease or history of any arterial thromboembolic event within 6 months prior to the first dose of study treatment
- •Clinically severe pulmonary compromise (including but not limited to baseline oxygen saturation of <90% on room air) resulting from intercurrent pulmonary illnesses
- •Major surgery within 4 weeks prior to the first dose of study treatment.
研究组 & 干预措施
ZL-1310 in Combination with Checkpoint Inhibitor
Experimental
干预措施: ZL-1310 in combination with Atezolizumab or Durvalumab (Combination Product)
Standard of Care Platinum-based Chemotherapy with a Checkpoint Inhibitor
Active Comparator
干预措施: Carboplatin/Etoposide in Combination with Atezolizumab followed by maintenance Atezolizumab with Lurbinectedin (Combination Product)
Standard of Care Platinum-based Chemotherapy with a Checkpoint Inhibitor
Active Comparator
干预措施: Carboplatin/Etoposide or Cistplatin/Etoposide in Combination with Durvalumab induction followed by Durvalumab maintenance (Combination Product)
结局指标
主要结局
Overall survival of ZL-1310 with IO compared to chemo with IO
时间窗: up to approximately 3 years
次要结局
- Changes from baseline in quality of life related parameters of ZL-1310 with IO compared to chemo with IO using EQ-5D (EQ visual analog scale [VAS]).(up to approximately 3 years)
- Duration of central nervous system response assessed by BICR and by the investigator per modified Response Assessment in Neuro-Oncology for Brain Metastases in participants with brain metastases at baseline of ZL-1310 with IO compared to chemo with IO(up to approximately 3 years)
- Incidence rate of new brain metastases in participants without baseline brain metastases of ZL-1310 with IO compared to chemo with IO(up to approximately 3 years)
- Time to first onset of new brain metastases in participants without baseline brain metastases of ZL-130(up to approximately 3 years)
- Changes from baseline in quality of life related parameters of ZL-1310 with IO compared to chemo with IO using EQ-5D (EQ-5D-5L index)(up to approximately 3 years)
- Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) and by investigator per RECIST v1.1 of ZL-1310 with IO compared to chemo with IO(up to approximately 3 years)
- Confirmed objective response rate (ORR) assessed by BICR and by investigator per RECIST v1.1 of ZL-1310 with IO compared to chemo with IO(up to approximately 3 years)
- Duration of response (DoR) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310with IO compared to chemo with IO(up to approximately 3 years)
- Time to response (TTR) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 with IO compared to chemo with IO(up to approximately 3 years)
- Confirmed central nervous system response assessed by BICR and by the investigator per modified Response Assessment in Neuro-Oncology for Brain Metastases in participants with brain metastases at baseline of ZL-1310 with IO compared to chemo with IO(up to approximately 3 years)
- Changes from baseline in quality of life related parameters of ZL-1310 with IO compared to chemo with IO using EORTC-QLQ-LC13(up to approximately 3 years)
- Changes from baseline in quality of life parameters of ZL-1310 with IO compared to chemo with IO using EORTC-QLQ-C30(up to approximately 3 years)
研究者
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