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NCT07720193Not yet recruitingPhase 3

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

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)

Source: ClinicalTrials.gov · Last updated 19 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
280 (estimated)
First submitted
17 Jul 2026
Start date
16 Nov 2026
Primary completion date
22 Dec 2030
Lead sponsor
Nanjing Leads Biolabs Co.,Ltd
NCT number
NCT07720193

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 280
  • From 16 Nov 2026 to the primary completion date, 22 Dec 2030
  • 36 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • serious cardiac and cerebrovascular disorder.
  • History of immunodeficiency including HIV antibody test positive.
  • patients with active hepatitis B or C.
  • The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.

Other

  • Diagnosed with Mixed neuroendocrine-non endocrine neoplasm (MiNENs).
  • Women during pregnancy or lactation.

Who the study is looking for

  • 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\~1.
  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (36)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Anyang Tumor Hospital
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AnyangChinaUnknown status
Beijing Cancer Hospital
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BeijingChinaUnknown status
Beijing GoBroad Hospital
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BeijingChinaUnknown status
The First Affiliated Hospital of Bengbu Medical University
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BengbuChinaUnknown status
The First Hospital of Jilin University
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ChangchunChinaUnknown status
Hunan Cancer Hospital
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ChangshaChinaUnknown status
Sichuan Provincial People's Hospital
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ChengduChinaUnknown status
Chongqing University Cancer Hospital
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ChongqingChinaUnknown status
Fujian Cancer Hospital
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FuzhouChinaUnknown status
Fujian Medical University Union Hospital
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FuzhouChinaUnknown status
The First Affiliated Hospital of Fujian Medical University
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FuzhouChinaUnknown status
The First Affiliated Hospital, Sun Yat-sen University
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GuangzhouChinaUnknown status
Sun Yat-sen University Cancer Center
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GuangzhouChinaUnknown status
The First Affiliated Hospital of Jinan University
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GuangzhouChinaUnknown status
Zhejiang Cancer Hospital
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HangzhouChinaUnknown status
Harbin Medical University Cancer Hospital
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HarbinChinaUnknown status
Shandong Cancer Hospital
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JinanChinaUnknown status
Yunnan Cancer Hospital
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KunmingChinaUnknown status
Gansu Cancer Hospital
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LanzhouChinaUnknown status
The First Affiliated Hospital of Henan University of Science &Technology
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LuoyangChinaUnknown status
The Second Affiliated Hospital of Nanchang University
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NanchangChinaUnknown status
The Affiliated Hospital of Nanjing university Medical School
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NanjingChinaUnknown status
Guangxi Medical University Cancer Hospital
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NanningChinaUnknown status
Fudan University Shanghai Cancer Center
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ShanghaiChinaUnknown status
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
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ShanghaiChinaUnknown status
Liaoning Cancer Hospital and Institute
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ShengyangChinaUnknown status
First Hospital of Shanxi Medical University
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TaiyuanChinaUnknown status
Shanxi Provincial Cancer Hospital
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TaiyuanChinaUnknown status
Tianjin Medical University Cancer Institute & Hospital
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TianjinChinaUnknown status
The First Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaUnknown status
The First Affiliated hospital of Xiamen University
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XiamenChinaUnknown status
The First Affiliated Hospital of Xi'an Jiaotong University
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Xi’anChinaUnknown status
The First Affiliated Hospital of Henan Medical University
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XinxiangChinaUnknown status
The affiliated hospital of xuzhou medical university
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XuzhouChinaUnknown status
Henan Cancer Hospital
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ZhengzhouChinaUnknown status
The First Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.