A Clinical Trial of LBL-024 Combined With Etoposide and Platinum in Patients With Advanced Neuroendocrine Carcinoma
An Open-label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of LBL-024 Combined With Etoposide and Platinum in the First-line Treatment of Patients With Advanced Neuroendocrine Carcinoma (NEC)
1 other identifier
interventional
178
1 country
25
Brief Summary
An open-label, multicenter phase Ib/II clinical study to evaluate the safety and efficacy of LBL-024 combined with etoposide and platinum in the first-line treatment of patients with advanced neuroendocrine carcinoma (NEC)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2023
Typical duration for phase_1
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2023
CompletedFirst Posted
Study publicly available on registry
December 6, 2023
CompletedStudy Start
First participant enrolled
December 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 28, 2027
March 12, 2026
March 1, 2026
3.1 years
November 27, 2023
March 10, 2026
Conditions
Outcome Measures
Primary Outcomes (5)
Objective Response Rate (ORR)
ORR (including the rates of complete response (CR) and partial response (PR)), evaluated based on the RECIST 1.1, refers to the percentage of study subjects who achieve a complete response or partial response. It was used to evaluate the efficacy in Phase II .
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).
Dose-limiting toxicities（DLT）
DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. It was used to evaluate the safety in Phase Ib.
Within 3 weeks after receiving the first dose of the test drug (DLT assessment for subjects in dose escalation phase).
Progression-Free Survival(PFS)
PFS is defined as the time from randomization to disease progression or death from any cause.It was used to evaluate the efficacy in Phase II .
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)
Adverse event (AE) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0.The safety profile of LBL-024 Combination Administration will be assessed by monitoring the adverse event (AE) and serious adverse event (SAE) in Phase Ib study.
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)
The recommended Phase 2 dose (RP2D)
The recommended Phase 2 dose (RP2D) will be determined comprehensively based on the safety, tolerability, efficacy and PK data from the clinical studies of LBL-024 in advance.
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 (5)
Cmax
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
Tmax
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
immunogenicity
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
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)
Study Arms (2)
LBL-024+Etoposide+Carboplatin/Cisplatin
EXPERIMENTALLBL-024+Etoposide+Carboplatin/Cisplatin Intravenous infusion.
Atezolizumab+Etoposide+Carboplatin
ACTIVE COMPARATORAtezolizumab+Etoposide+Carboplatin Intravenous infusion.
Interventions
intravenous infusion
intravenous infusion
intravenous infusion
intravenous infusion
intravenous infusion
Eligibility Criteria
You may qualify if:
- Agree to follow the trial treatment regimen and visit schedule, voluntarily enroll, and sign the written informed consent.
- aged 18-75 years (including borderline values) at the time of signing the informed consent form
- The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\~1.
- The expected survival time is at least 12 weeks.
- According to the evaluation of RECIST 1.1 （Response Evaluation Criteria in Solid Tumours），the subjects enrolled have at least one measurable target lesion.
- Fertile men and women of childbearing age are willing to take effective contraceptive measures from the signing of the informed consent form to 6 months after the last dose of the investigational drug; women of childbearing age include premenopausal women and women who had menopause less than two years ago. Blood pregnancy test results must be negative for women of childbearing age within 7 days prior to the initial dose of the investigational drug.
You may not qualify if:
- Subjects who underwent major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the initial use of the investigational drug, or require elective surgery during the trial period
- Use of immunomodulatory drugs within 14 days prior to the initial use of the investigational drug, including but not limited to thymosin, interleukin, and interferon
- Subjects with an active infection that currently requires intravenous anti-infective therapy.
- Clinically uncontrollable pleural effusion, pericardial effusion, and requiring repeated drainage or medical intervention.
- medical history of immunodeficiency including HIV antibody positive.
- Pregnant or lactating women.
- The investigator believes that the subject has other conditions that may affect compliance or that are not suitable for participating in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Anhui Provincial Hospital
Hefei, Anhui, 230001, China
Anhui Cancer Hospital
Hefei, Anhui, 230031, China
Beijing GoBroad Hospital
Beijing, Beijing Municipality, 100070, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
Sun Yat-sen University Cancer Center (SYSUCC)
Guangzhou, Guangdong, 510060, China
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, 510080, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003, China
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Xiangyang Central Hospital
Xiangyang, Hubei, 441000, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Liaoning Cancer Hospital
Shenyang, Liaoning, 110801, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250063, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Shanxi Cancer hospital
Taiyuan, Shanxi, 030013, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044, China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
Sir Run Run Shaw Hospital，Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016, 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 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2023
First Posted
December 6, 2023
Study Start
December 8, 2023
Primary Completion (Estimated)
December 28, 2026
Study Completion (Estimated)
March 28, 2027
Last Updated
March 12, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share