A Randomized, Double-blind, Placebo-controlled, Phase III Trial of LBL-024 Combined With Platinum-based Chemotherapy as First-line Treatment of Patients With Advanced Extrapulmonary Neuroendocrine Carcinoma (EP-NEC)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 280
- 试验地点
- 28
- 主要终点
- Overall survival (OS)
研究概览
简要总结
This trial is a randomized, double-blind, placebo-controlled multicenter phase III clinical study aiming to evaluate the efficacy and safety of LBL-024 compared with placebo in combination with etoposide and cisplatin or carboplatin (EP or EC) for the first-line treatment of advanced EP-NEC patients.
详细描述
A total of 280 patients with advanced EP-NEC without systemic treatment will be enrolled in this study. Eligible patients will be randomly assigned to the experimental group or control group at a ratio of 1:1.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Agrees to follow the investigational treatment protocol, visit schedule and laboratory test, comply with other requirements of the protocol, voluntarily enroll, and sign a written informed consent.
- •Age ≥ 18 years (inclusive) at the time of signing informed consent.
- •The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0~
- •expected survival time of at least 12 weeks.
- •According to RECIST 1.1, participants were required to have at least one measurable lesion.
- •Male of childbearing potential and Females of childbearing age are willing to take highly effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug.
排除标准
- •Diagnosed with Mixed neuroendocrine-non endocrine neoplasm (MiNENs).
- •Major surgery (other than aspiration biopsy) within 28 days prior to the first dose of study drug or significant trauma,or required to undergo scheduled surgery during the trial.
- •Use of immunomodulatory drugs within 14 days before the first use of study drug,Including but not limited to thymopeptide, interleukins, interferon, etc.
- •Patients with active infection requiring intravenous anti-infective therapy within 2 weeks prior to the first dose of study drug.
- •serious cardiac and cerebrovascular disorder.
- •History of immunodeficiency including HIV antibody test positive.
- •patients with active hepatitis B or C.
- •Women during pregnancy or lactation.
- •The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.
研究组 & 干预措施
LBL-024 placebo+ Etoposide + Cisplatin/carboplatin
LBL-024 placebo+ Etoposide + Cisplatin/carbopla.
Intravenous infusion.
干预措施: Carboplatin injection (Drug)
LBL-024 + Etoposide + Cisplatin/carboplatin
LBL-024 + Etoposide + Cisplatin/carboplatin.
Intravenous infusion.
干预措施: Cisplatin injection (Drug)
LBL-024 placebo+ Etoposide + Cisplatin/carboplatin
LBL-024 placebo+ Etoposide + Cisplatin/carbopla.
Intravenous infusion.
干预措施: Etoposide injection (Drug)
LBL-024 placebo+ Etoposide + Cisplatin/carboplatin
LBL-024 placebo+ Etoposide + Cisplatin/carbopla.
Intravenous infusion.
干预措施: Cisplatin injection (Drug)
LBL-024 + Etoposide + Cisplatin/carboplatin
LBL-024 + Etoposide + Cisplatin/carboplatin.
Intravenous infusion.
干预措施: LBL-024 for Injection (Drug)
LBL-024 placebo+ Etoposide + Cisplatin/carboplatin
LBL-024 placebo+ Etoposide + Cisplatin/carbopla.
Intravenous infusion.
干预措施: LBL-024 placebo for injection (Drug)
LBL-024 + Etoposide + Cisplatin/carboplatin
LBL-024 + Etoposide + Cisplatin/carboplatin.
Intravenous infusion.
干预措施: Etoposide injection (Drug)
LBL-024 + Etoposide + Cisplatin/carboplatin
LBL-024 + Etoposide + Cisplatin/carboplatin.
Intravenous infusion.
干预措施: Carboplatin injection (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
Time from randomization to death for any reason in a clinical trial.
次要结局
- Objective Response Rate (ORR)(From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy))
- Disease Control Rate(DCR）(From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy))
- Progression-free Survival(PFS)(From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy))
- Occurrence of adverse event (AE) and serious adverse event (SAE)(From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (90 days after drug withdrawal or before the start of new anti-tumor therapy))
- Cmax(From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy))
- Tmax(From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy))
- Immunogenicity(From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy))
- Duration of Response(DOR）(From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy))