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NOT YET RECRUITING
NCT07720193
PHASE3

A Phase III Trial of LBL-024 Combined With Platinum-based Chemotherapy as First-line Treatment for Advanced EP-NEC

Sponsor: Nanjing Leads Biolabs Co.,Ltd

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

280

Start Date

2026-08-22

Completion Date

2030-12-22

Last Updated

2026-07-22

Healthy Volunteers

No

Interventions

DRUG

LBL-024 for Injection

Intravenous infusion

DRUG

Etoposide injection

Intravenous infusion

DRUG

Cisplatin injection

Intravenous infusion

DRUG

Carboplatin injection

Intravenous infusion

DRUG

LBL-024 placebo for injection

Intravenous infusion

Locations (17)

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