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

Zelgen Biopharmaceuticals

Status and phase: Not yet enrolling; Phase 3

Conditions: Neuroendocrine Carcinomas (NEC)

Treatments: Drug: Cisplatin Injection; Drug: Etoposide Injection; Drug: ZG005 placebo for injection; Drug: ZG005 for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07833839

ZG005-010

Details and patient eligibility

About

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.

Enrollment: 440 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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440 participants in 2 patient groups

ZG005 + Etoposide + Cisplatin

Experimental group

Description:

Treatment arm

Treatment:

Drug: ZG005 for Injection

Drug: Etoposide Injection

Drug: Cisplatin Injection

ZG005 Placebo + Etoposide + Cisplatin

Active Comparator group

Description:

Control arm

Treatment:

Drug: ZG005 placebo for injection

Drug: Etoposide Injection

Drug: Cisplatin Injection