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Starting soon Phase 3

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

NCT07720193 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2026-11-16
Last updated
2026-10-19

Condition(s) studied

Advanced Extrapulmonary Neuroendocrine Carcinoma

Investigational drug(s) / intervention(s)

LBL-024 for Injection →Etoposide injection →Cisplatin injection →Carboplatin injection →LBL-024 placebo for injection

LBL-024 for Injection: Intravenous infusion

Etoposide injection: Intravenous infusion

Cisplatin injection: Intravenous infusion

Carboplatin injection: Intravenous infusion

LBL-024 placebo for injection: Intravenous infusion

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Overall survival (OS) — 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.

Trial sites (36)

FacilityCityRegionStatus
The First Affiliated Hospital of Bengbu Medical University Bengbu Anhui
Beijing GoBroad Hospital Beijing Beijing Municipality
Beijing Cancer Hospital Beijing Beijing Municipality
Chongqing University Cancer Hospital Chongqing Chongqing Municipality
Fujian Medical University Union Hospital Fuzhou Fujian
The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian
Fujian Cancer Hospital Fuzhou Fujian
The First Affiliated Hospital of Xiamen University Xiamen Fujian
Gansu Cancer Hospital Lanzhou Gansu
Sun Yat-sen University Cancer Center Guangzhou Guangdong
The First Affiliated Hospital,Sun Yat-sen University Guangzhou Guangdong
The First Affiliated Hospital of Jinan University Guangzhou Guangdong
Guangxi Medical University Cancer Hospital Nanning Guangxi
Harbin Medical University Cancer Hospital Harbin Heilongjiang
AnYang Tumor Hospital Anyang Henan
The First Affiliated Hospital of Henan University of Science & Technology Luoyang Henan
The First Affiliated Hospital of Henan Medical University Xinxiang Henan
Henan Cancer Hospital Zhengzhou Henan
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan
Hunan Cancer Hospital Changsha Hunan
The Affiliated Hospital of Nanjing University Medical School Nanjing Jiangsu
The Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu
The Second Affiliated Hospital of Nanchang University Nanchang Jiangxi
The First Hospital of Jilin University Changchun Jilin
Liaoning Cancer Hospital and Institute Shengyang Liaoning
Shandong Cancer Hospital Jinan Shandong
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality
Shanxi Provincial Cancer Hospital Taiyuan Shanxi
First Hospital of Shanxi Medical University Taiyuan Shanxi
The First Affiliated Hospital of Xi'an Jiaotong University Xi’an Shanxi
Sichuan Provincial People's Hospital Chengdu Sichuan
Tianjin Medical University Cancer Institute & Hospital Tianjin Tianjin Municipality
Yunnan Cancer Hospital Kunming Yunnan
Zhejiang Cancer Hospital Hangzhou Zhejiang
The First Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07720193 on ClinicalTrials.gov ↗ ← All trials in China