This is a randomized, multicenter, phase Ib study to evaluate the safety and efficacy of ZG006 combined with PD-1/PD-L1 immune checkpoint inhibitors (±chemotherapy) as first-line therapy in Participants with extensive stage small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
ZG006 will be administered as an IV infusion.
Serplulimab will be administered as an IV infusion.
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGNumber of Participants Experiencing Dose-limiting toxicities (DLTs)
Time frame: Up to Day 28
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 2 Years
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: Up to 2 Years
Maximum Serum Concentration (Cmax) of ZG006
Time frame: Up to 2 Years
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval for ZG006
Time frame: Up to 2 Years
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