Neuroendocrine Carcinomas (NEC)
Conditions
Brief summary
This is a randomized, double-blind, controlled, multicenter Phase III study evaluating the efficacy, safety, pharmacokinetics, and immunogenicity of ZG005 combined with the EP regimen (etoposide plus cisplatin) in participants with advanced NEC who are naive to systemic therapy.
Interventions
Intravenous infusion
Intravenous infusion
DRUGCisplatin Injection
Intravenous infusion
DRUGZG005 placebo for injection
Intravenous infusion
Sponsors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Participant has fully understood the trial, agrees to comply with the study treatment regimen and visit schedule, and voluntarily signs the informed consent form (ICF). * Male or female participants aged 18 to 75 years (inclusive) at the time of signing the informed consent form (ICF). * Life expectancy of more than 3 months. * Histologically confirmed recurrent or metastatic neuroendocrine carcinoma (NEC). * The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\~1.
Exclusion criteria
* History, computed tomography (CT), or magnetic resonance imaging (MRI) findings suggestive of central nervous system (CNS) metastases or leptomeningeal metastases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS) | Up to 48 months |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) | Up to 48 months |
| Objective Response Rate (ORR) | Up to 48 months |
| Duration of response (DoR) | Up to 48 months |
| Occurrence of adverse event (AE) and serious adverse event (SAE) | Up to 48 months |
Countries
China
Contacts
CONTACTShangdi Ning
Outcome results
None listed