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

July 17, 2026 updated by: Nanjing Leads Biolabs Co.,Ltd

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)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

A total of 280 patients with advanced EP-NEC without systemic treatment will be enrolled in this study. Eligible patients will be randomly assigned to the experimental group or control group at a ratio of 1:1.

Study Type

Interventional

Enrollment (Estimated)

280

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
      • Beijing, Beijing Municipality, China, 100070
    • Fujian
      • Fuzhou, Fujian, China, 350014
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-Sen University Cancer Center
        • Contact:
      • Guangzhou, Guangdong, China, 510062
        • The First Affiliated Hospital,Sun Yat-sen University
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530200
        • Guangxi Medical University Cancer Hospital
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Harbin Medical University Cancer Hospital
        • Contact:
    • Henan
      • Luoyang, Henan, China, 471023
        • The First Affiliated Hospital of Henan University of Science & Technology
        • Contact:
      • Zhengzhou, Henan, China, 450003
    • Shandong
      • Jinan, Shandong, China, 250117
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Fudan University Shanghai Cancer Center
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030013
        • Shanxi Provincial Cancer Hospital
        • Contact:
      • Taiyuan, Shanxi, China, 30012
        • First Hospital of Shanxi Medical University
        • Contact:
      • Xi’an, Shanxi, China, 710061
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Sichuan Provincial People's Hospital
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650118
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LBL-024 + Etoposide + Cisplatin/carboplatin

LBL-024 + Etoposide + Cisplatin/carboplatin.

Intravenous infusion.
Drug: LBL-024 for Injection
Intravenous infusion
Other Names:
  • LBL-024
Drug: Etoposide injection
Intravenous infusion
Other Names:
  • Etoposide
Drug: Cisplatin injection
Intravenous infusion
Other Names:
  • Cisplatin
Drug: Carboplatin injection
Intravenous infusion
Other Names:
  • Carboplatin
Active Comparator: LBL-024 placebo+ Etoposide + Cisplatin/carboplatin

LBL-024 placebo+ Etoposide + Cisplatin/carbopla.

Intravenous infusion.
Drug: Etoposide injection
Intravenous infusion
Other Names:
  • Etoposide
Drug: Cisplatin injection
Intravenous infusion
Other Names:
  • Cisplatin
Drug: Carboplatin injection
Intravenous infusion
Other Names:
  • Carboplatin
Drug: LBL-024 placebo for injection
Intravenous infusion
Other Names:
  • LBL-024 placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: 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)
Maximum drug concentration in plasma after administration.
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
Time Frame: 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)
After administration,Time to reach maximum drug concentration in plasma.
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
Time Frame: 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)
The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects.Immunogenicity refers to the performance that can elicit an immune response.
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)
Objective Response Rate (ORR)
Time Frame: 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)
Objective Response Rate (complete response (CR) + partial response (PR)), as assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1), refers to the percentage of study subjects who achieve a complete response or partial response.
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）
Time Frame: 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)
Percentage of participants achieving CR, PR, iCR, iPR and stable disease (SD) after treatment..
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）
Time Frame: 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)
DOR is defined as the duration from earliest date of disease response (CR、PR 、iCR or iPR) until earliest date of disease progression or death from any cause(if occurring sooner than progression).
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)
Time Frame: 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)
According to the evaluation criteria of RECIST V1.1 (solid tumour),Time from first dose to disease progression or death from any cause.It was used to evaluate Time of disease no-progression or Drug resistance .
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)
Time Frame: 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)
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 combination therapy will be assessed by monitoring the 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Leads Biolabs Co.,Ltd

Collaborators

Peking University Cancer Hospital & Institute

Investigators

  • Principal Investigator: Lin Shen, Peking University Cancer Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 22, 2026

Primary Completion (Estimated)

December 22, 2030

Study Completion (Estimated)

December 22, 2030

Study Registration Dates

First Submitted

July 17, 2026

First Submitted That Met QC Criteria

July 17, 2026

First Posted (Actual)

July 22, 2026

Study Record Updates

Last Update Posted (Actual)

July 22, 2026

Last Update Submitted That Met QC Criteria

July 17, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LBL-024-CN301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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