Advanced Extrapulmonary Neuroendocrine CarcinomaPhase 3NCT07720193
A Trial of LBL-024 Combined With Platinum-based Chemotherapy for the Treatment of Advanced EP-NEC
A Phase 3 study testing LBL-024 for Injection, Etoposide injection and Cisplatin injection in people with Advanced Extrapulmonary Neuroendocrine Carcinoma, run by Nanjing Leads Biolabs Co.,Ltd at 36 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Extrapulmonary Neuroendocrine Carcinoma
- What is being tested?
- LBL-024 for Injection, Etoposide injection and Cisplatin injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 36 sitesChina
- Study dates
- 16 Nov 2026to 22 Dec 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
36 sites in 1 country. Contact the study team or a site near you to ask about taking part.
36 sites in 1 country
China36 sites
AnYang Tumor Hospital
Anyang, Henan, 455000
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Beijing GoBroad Hospital
Beijing, Beijing Municipality, 100070
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233004
The First Hospital of Jilin University
Changchun, Jilin, 130021
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Hunan Cancer Hospital
Changsha, Hunan, 410013
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, Guangdong, 510062
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510630
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Shandong Cancer Hospital
Jinan, Shandong, 250117
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Yunnan Cancer Hospital
Kunming, Yunnan, 650118
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Gansu Cancer Hospital
Lanzhou, Gansu, 730050
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, 471023
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330200
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530200
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Liaoning Cancer Hospital and Institute
Shengyang, Liaoning, 110167
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030013
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 30012
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361102
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
The First Affiliated Hospital of Henan Medical University
Xinxiang, Henan, 453100
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221006
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
Henan Cancer Hospital
Zhengzhou, Henan, 450003
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
xiangyu Ma, 02583378099, maxy@leadsbiolabs.com
About this study
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)
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.
Read the 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.
- Being tested
- LBL-024 for Injection, Etoposide injection, Cisplatin injection, Carboplatin injection, LBL-024 placebo for injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBL-024 for InjectionDrug
Also called LBL-024
Intravenous infusion
Etoposide injectionDrug
Also called Etoposide
Intravenous infusion
Cisplatin injectionDrug
Also called Cisplatin
Intravenous infusion
Carboplatin injectionDrug
Also called Carboplatin
Intravenous infusion
LBL-024 placebo for injectionDrug
Also called LBL-024 placebo
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| LBL-024 + Etoposide + Cisplatin/carboplatin | Experimental | LBL-024 + Etoposide + Cisplatin/carboplatin.
Intravenous infusion. Receives: Drug: LBL-024 for Injection; Drug: Etoposide injection; Drug: Cisplatin injection; Drug: Carboplatin injection |
| LBL-024 placebo+ Etoposide + Cisplatin/carboplatin | Active comparator | LBL-024 placebo+ Etoposide + Cisplatin/carbopla.
Intravenous infusion. Receives: Drug: Etoposide injection; Drug: Cisplatin injection; Drug: Carboplatin injection; Drug: LBL-024 placebo for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Time from randomization to death for any reason in a clinical trial.
Measured: 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)
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.
Measured: 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）
Percentage of participants achieving complete response (CR) or partial response (PR) and stable disease (SD) after treatment.
Measured: 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）
DoR (per RECIST 1.1) is defined as the time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.
Measured: 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)
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 .
Measured: 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 combination therapy will be assessed by monitoring the adverse event (AE) and serious adverse event (SAE).
Measured: 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)
Cmax
Maximum drug concentration in plasma after administration.
Measured: 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
After administration,Time to reach maximum drug concentration in plasma.
Measured: 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
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start16 Nov 2026 (estimated)
- Primary completion22 Dec 2030 (estimated)
- Study completion22 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Extrapulmonary Neuroendocrine CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Leads Biolabs Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University Cancer Hospital & Institute
- Responsible party
- Sponsor
- Investigators
- Lin Shen, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720193
- Sponsor's protocol ID
- LBL-024-CN301
- Status last verified
- Oct 2026
- First submitted
- 17 Jul 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No