NCT07720193Not yet recruitingPhase 3
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)
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 280 (estimated)
- First submitted
- 17 Jul 2026
- Start date
- 16 Nov 2026
- Primary completion date
- 22 Dec 2030
- Lead sponsor
- Nanjing Leads Biolabs Co.,Ltd
- Diseases
- Neuroendocrine tumours
- NCT number
- NCT07720193
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 280
- From 16 Nov 2026 to the primary completion date, 22 Dec 2030
- 36 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- serious cardiac and cerebrovascular disorder.
- History of immunodeficiency including HIV antibody test positive.
- patients with active hepatitis B or C.
- The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.
Other
- Diagnosed with Mixed neuroendocrine-non endocrine neoplasm (MiNENs).
- Women during pregnancy or lactation.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (36)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anyang Tumor Hospital Coordinator of this site? Confirm its status | Anyang | China | Unknown status |
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing GoBroad Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Affiliated Hospital of Bengbu Medical University Coordinator of this site? Confirm its status | Bengbu | China | Unknown status |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Sichuan Provincial People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Chongqing University Cancer Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Fujian Cancer Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| The First Affiliated Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| The First Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Affiliated Hospital of Jinan University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Shandong Cancer Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Yunnan Cancer Hospital Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| Gansu Cancer Hospital Coordinator of this site? Confirm its status | Lanzhou | China | Unknown status |
| The First Affiliated Hospital of Henan University of Science &Technology Coordinator of this site? Confirm its status | Luoyang | China | Unknown status |
| The Second Affiliated Hospital of Nanchang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| The Affiliated Hospital of Nanjing university Medical School Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Guangxi Medical University Cancer Hospital Coordinator of this site? Confirm its status | Nanning | China | Unknown status |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Liaoning Cancer Hospital and Institute Coordinator of this site? Confirm its status | Shengyang | China | Unknown status |
| First Hospital of Shanxi Medical University Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Shanxi Provincial Cancer Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Tianjin Medical University Cancer Institute & Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| The First Affiliated hospital of Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Unknown status |
| The First Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi’an | China | Unknown status |
| The First Affiliated Hospital of Henan Medical University Coordinator of this site? Confirm its status | Xinxiang | China | Unknown status |
| The affiliated hospital of xuzhou medical university Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.