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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
440
Intravenous infusion
Intravenous infusion
Intravenous infusion
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Overall survival (OS)
Time frame: Up to 48 months
Progression-free survival (PFS)
Time frame: Up to 48 months
Objective Response Rate (ORR)
Time frame: Up to 48 months
Duration of response (DoR)
Time frame: Up to 48 months
Occurrence of adverse event (AE) and serious adverse event (SAE)
Time frame: Up to 48 months
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Intravenous infusion