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)
1 other identifier
interventional
280
1 country
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2026
Typical duration for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2026
CompletedFirst Posted
Study publicly available on registry
July 22, 2026
CompletedStudy Start
First participant enrolled
August 22, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2030
Study Completion
Last participant's last visit for all outcomes
December 22, 2030
July 24, 2026
July 1, 2026
4.3 years
July 17, 2026
July 22, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival (OS)
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)
Secondary Outcomes (8)
Objective Response Rate (ORR)
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)
Disease Control Rate(DCR）
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）
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)
Progression-free Survival(PFS)
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)
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)
- +3 more secondary outcomes
Study Arms (2)
LBL-024 + Etoposide + Cisplatin/carboplatin
EXPERIMENTALLBL-024 + Etoposide + Cisplatin/carboplatin. Intravenous infusion.
LBL-024 placebo+ Etoposide + Cisplatin/carboplatin
ACTIVE COMPARATORLBL-024 placebo+ Etoposide + Cisplatin/carbopla. Intravenous infusion.
Interventions
Intravenous infusion
Intravenous infusion
Intravenous infusion
Intravenous infusion
Intravenous infusion
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Beijing GoBroad Hospital
Beijing, Beijing Municipality, 100070, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, Guangdong, 510062, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530200, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, 471023, China
Henan Cancer Hospital
Zhengzhou, Henan, 450003, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030013, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 30012, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650118, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lin Shen
Peking University Cancer Hospital & Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2026
First Posted
July 22, 2026
Study Start (Estimated)
August 22, 2026
Primary Completion (Estimated)
December 22, 2030
Study Completion (Estimated)
December 22, 2030
Last Updated
July 24, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share