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A Trial of LBL-024 Combined With Platinum-based Chemotherapy for the Treatment of Advanced EP-NEC

2026年8月31日 更新者：Nanjing Leads Biolabs Co.,Ltd

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)

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

280

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100142
      • Beijing、Beijing Municipality、中国、100070
        • Beijing GoBroad Hospital
        • 接触：
    • Fujian
      • Fuzhou、Fujian、中国、350001
        • Fujian Medical University Union Hospital
        • 接触：
      • Fuzhou、Fujian、中国、350014
    • Gansu
      • Lanzhou、Gansu、中国、730050
    • Guangdong
      • Guangzhou、Guangdong、中国、510060
        • Sun Yat-sen University Cancer Center
        • 接触：
      • Guangzhou、Guangdong、中国、510630
        • The First Affiliated Hospital of Jinan University
        • 接触：
      • Guangzhou、Guangdong、中国、510062
        • The First Affiliated Hospital,Sun Yat-sen University
        • 接触：
    • Guangxi
      • Nanning、Guangxi、中国、530200
        • Guangxi Medical University Cancer Hospital
        • 接触：
    • Heilongjiang
      • Harbin、Heilongjiang、中国、150081
        • Harbin Medical University Cancer Hospital
        • 接触：
    • Henan
      • Luoyang、Henan、中国、471023
        • The First Affiliated Hospital of Henan University of Science & Technology
        • 接触：
      • Zhengzhou、Henan、中国、450003
    • Hunan
      • Changsha、Hunan、中国、410013
    • Jiangsu
      • Nanjing、Jiangsu、中国、210008
        • The Affiliated Hospital of Nanjing University Medical School
        • 接触：
      • Xuzhou、Jiangsu、中国、221006
        • The Affiliated Hospital of Xuzhou Medical University
        • 接触：
    • Jiangxi
      • Nanchang、Jiangxi、中国、330200
        • The Second Affiliated Hospital of Nanchang University
        • 接触：
    • Jilin
      • Changchun、Jilin、中国、130021
        • The First Hospital of Jilin University
        • 接触：
    • Shandong
      • Jinan、Shandong、中国、250117
        • Shandong Cancer Hospital
        • 接触：
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200032
        • Fudan University Shanghai Cancer Center
        • 接触：
      • Shanghai、Shanghai Municipality、中国、200025
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • 接触：
    • Shanxi
      • Taiyuan、Shanxi、中国、030013
        • Shanxi Provincial Cancer Hospital
        • 接触：
      • Taiyuan、Shanxi、中国、30012
        • First Hospital of Shanxi Medical University
        • 接触：
      • Xi’an、Shanxi、中国、710061
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • 接触：
    • Sichuan
      • Chengdu、Sichuan、中国、610072
        • Sichuan Provincial People's Hospital
        • 接触：
    • Tianjin Municipality
      • Tianjin、Tianjin Municipality、中国、300060
        • Tianjin Medical University Cancer Institute & Hospital
        • 接触：
    • Yunnan
      • Kunming、Yunnan、中国、650118
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310022
        • Zhejiang Cancer Hospital
        • 接触：
      • Wenzhou、Zhejiang、中国、325000
        • The First Affiliated Hospital of Wenzhou Medical University
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. 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.
  2. Age ≥ 18 years (inclusive) at the time of signing informed consent.
  3. The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0~1.
  4. expected survival time of at least 12 weeks.
  5. According to RECIST 1.1, participants were required to have at least one measurable lesion.
  6. 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.

Exclusion Criteria:

  1. Diagnosed with Mixed neuroendocrine-non endocrine neoplasm (MiNENs).
  2. 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.
  3. Use of immunomodulatory drugs within 14 days before the first use of study drug,Including but not limited to thymopeptide, interleukins, interferon, etc.
  4. Patients with active infection requiring intravenous anti-infective therapy within 2 weeks prior to the first dose of study drug.
  5. serious cardiac and cerebrovascular disorder.
  6. History of immunodeficiency including HIV antibody test positive.
  7. patients with active hepatitis B or C.
  8. Women during pregnancy or lactation.
  9. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：LBL-024 + Etoposide + Cisplatin/carboplatin

LBL-024 + Etoposide + Cisplatin/carboplatin.

Intravenous infusion.
药品：注射用 LBL-024
静脉输注
其他名称：
  • LBL-024
药品：Etoposide injection
Intravenous infusion
其他名称：
  • 依托泊甙
药品：Cisplatin injection
Intravenous infusion
其他名称：
  • 顺铂
药品：Carboplatin injection
Intravenous infusion
其他名称：
  • 卡铂
有源比较器：LBL-024 placebo+ Etoposide + Cisplatin/carboplatin

LBL-024 placebo+ Etoposide + Cisplatin/carbopla.

Intravenous infusion.
药品：Etoposide injection
Intravenous infusion
其他名称：
  • 依托泊甙
药品：Cisplatin injection
Intravenous infusion
其他名称：
  • 顺铂
药品：Carboplatin injection
Intravenous infusion
其他名称：
  • 卡铂
药品：LBL-024 placebo for injection
Intravenous infusion
其他名称：
  • LBL-024 placebo

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Overall survival (OS)
大体时间：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.
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)

次要结果测量

结果测量
措施说明
大体时间
Cmax
大体时间：从所有受试者签署了签署知情同意书，直到戒毒的随访期结束（在戒毒后或在新的抗肿瘤疗法开始之前28天）
给药后血浆中的最大药物浓度。
从所有受试者签署了签署知情同意书，直到戒毒的随访期结束（在戒毒后或在新的抗肿瘤疗法开始之前28天）
Tmax
大体时间：从所有受试者签署了签署知情同意书，直到戒毒的随访期结束（在戒毒后或在新的抗肿瘤疗法开始之前28天）
给药后，在血浆中达到最大药物浓度的时间。
从所有受试者签署了签署知情同意书，直到戒毒的随访期结束（在戒毒后或在新的抗肿瘤疗法开始之前28天）
免疫原性
大体时间：从所有受试者签署了签署知情同意书，直到戒毒的随访期结束（在戒毒后或在新的抗肿瘤疗法开始之前28天）
免疫原性是通过抗药物抗体（ADA）的发生率和中和抗体（如果适用的）进行评估的。免疫原性是指可引起免疫反应的性能。
从所有受试者签署了签署知情同意书，直到戒毒的随访期结束（在戒毒后或在新的抗肿瘤疗法开始之前28天）
客观响应率（ORR）
大体时间：从所有受试者签署了签署知情同意书，直到戒毒的随访期结束（在戒毒后或在新的抗肿瘤疗法开始之前28天）
客观响应率（完全响应（CR） +部分响应（PR））通过实体瘤的响应评估标准评估（RECIST 1.1），是指实现完全响应或部分响应的研究对象的百分比。
从所有受试者签署了签署知情同意书，直到戒毒的随访期结束（在戒毒后或在新的抗肿瘤疗法开始之前28天）
Progression-free Survival(PFS)
大体时间：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)
According to the evaluation criteria of RECIST V1.1 (solid tumour),Time from first dose to disease progression or death from any cause.It was used to evaluate Time of disease no-progression or Drug resistance .
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)
大体时间：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)
Adverse event (AE) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0.The safety profile of combination therapy will be assessed by monitoring the 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)
Disease Control Rate(DCR）
大体时间：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)
Percentage of participants achieving complete response (CR) or partial response (PR) and stable disease (SD) after treatment.
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）
大体时间：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)
DoR (per RECIST 1.1) is defined as the time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.
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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Nanjing Leads Biolabs Co.,Ltd

合作者

Peking University Cancer Hospital & Institute

调查人员

  • 首席研究员：Lin Shen、Peking University Cancer Hospital & Institute

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月22日

初级完成 (估计的)

2030年12月22日

研究完成 (估计的)

2030年12月22日

研究注册日期

首次提交

2026年7月17日

首先提交符合 QC 标准的

2026年7月17日

首次发布 (实际的)

2026年7月22日

研究记录更新

最后更新发布 (实际的)

2026年9月1日

上次提交的符合 QC 标准的更新

2026年8月31日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • LBL-024-CN301

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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