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

ConditionNeuroendocrine Carcinomas (NEC)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

History, computed tomography (CT), or magnetic resonance imaging (MRI) findings suggestive of central nervous system (CNS) metastases or leptomeningeal metastases.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ZG005 for Injection

    Drug

    Intravenous infusion

  • Etoposide Injection

    Drug

    Intravenous infusion

  • Cisplatin Injection

    Drug

    Intravenous infusion

  • ZG005 placebo for injection

    Drug

    Intravenous infusion

Treatment groups

440 Participants
are divided into 2 treatment groups
Group A: ZG005 + Etoposide + CisplatinExperimental treatment 3 interventions
Group B: ZG005 Placebo + Etoposide + CisplatinActive comparator 3 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: