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NCT Number: NCT07833839

ZG005 Plus Etoposide and Cisplatin vs. Etoposide and Cisplatin as First-Line Treatment for Advanced Neuroendocrine Carcinoma

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.

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Key information

Conditions

Neuroendocrine Carcinomas (NEC) Adenocarcinoma Carcinoma Carcinoma, Neuroendocrine Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location contact

Lijie Song

CONTACT

[email protected]

13939020459

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ZG005 for Injection

Drug

Intravenous infusion

Etoposide injection

Drug

Intravenous infusion

Cisplatin injection

Drug

Intravenous infusion

ZG005 placebo for injection

Drug

Intravenous infusion

Primary outcomes

  1. Overall survival (OS)

    Time frame: Up to 48 months

Secondary outcomes

  1. Progression-free survival (PFS)

    Time frame: Up to 48 months

  2. Objective Response Rate (ORR)

    Time frame: Up to 48 months

  3. Duration of response (DoR)

    Time frame: Up to 48 months

  4. Occurrence of adverse event (AE) and serious adverse event (SAE)

    Time frame: Up to 48 months

Study contacts

Contact information is provided by the study sponsor or research team.

Shangdi Ning

CONTACT

[email protected]

+86-0512-57309965

Sponsors and collaborators

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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