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

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Advanced Extrapulmonary Neuroendocrine Carcinoma

In brief

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.

Key facts

Study ID

NCT07720193

Run by

Nanjing Leads Biolabs Co.,Ltd

People needed

280

Starts

2026-08-22

Expected to finish

2030-12-22

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Beijing GoBroad Hospital — Beijing, Beijing Municipality, China
• Beijing Cancer Hospital — Beijing, Beijing Municipality, China
• Fujian Cancer Hospital — Fuzhou, Fujian, China
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China
• The First Affiliated Hospital,Sun Yat-sen University — Guangzhou, Guangdong, China
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China
• The First Affiliated Hospital of Henan University of Science & Technology — Luoyang, Henan, China
• Henan Cancer Hospital — Zhengzhou, Henan, China
• Shandong Cancer Hospital — Jinan, Shandong, China
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China
• Shanxi Provincial Cancer Hospital — Taiyuan, Shanxi, China
• First Hospital of Shanxi Medical University — Taiyuan, Shanxi, China
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi’an, Shanxi, China
• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China
• Yunnan Cancer Hospital — Kunming, Yunnan, China
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China

Full record on ClinicalTrials.gov

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