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NCT07833839
ZG005 Plus Etoposide and Cisplatin vs. Etoposide and Cisplatin as First-Line Treatment for Advanced Neuroendocrine Carcinoma
Conditions: Neuroendocrine Carcinomas (NEC)
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 440
Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Location: The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07833839). StuddyBuddy aggregates publicly available trial information.