Clinical trial · Interventional
ZG005 Plus Etoposide and Cisplatin vs. Etoposide and Cisplatin as First-Line Treatment for Advanced Neuroendocrine Carcinoma
A Randomized, Double-Blind, Controlled, Multicenter Phase III Clinical Trial of ZG005 in Combination With Etoposide and Cisplatin Versus Etoposide and Cisplatin as First-Line Treatment for Advanced Neuroendocrine Carcinoma
NCT07833839CI-TRIAL-00126540not yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Carcinomas (NEC) | Neuroendocrine Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (4)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ZG005 + Etoposide + Cisplatin
- description
- Treatment arm
- interventionNames
- Drug: ZG005 for Injection
- Drug: Etoposide Injection
- Drug: Cisplatin Injection
- type
- ACTIVE_COMPARATOR
- label
- ZG005 Placebo + Etoposide + Cisplatin
- description
- Control arm
- interventionNames
- Drug: Etoposide Injection
- Drug: Cisplatin Injection
- Drug: ZG005 placebo for injection
Primary outcomes (1)
- measure
- Overall survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.