Study of ZG006 in Combination With PD-1/PD-L1 Immune Checkpoint Inhibitors as First-Line Standard Therapy in Participants With Extensive Stage Small-Cell Lung Cancer
ZG006: ZG006 will be administered as an IV infusion.
Serplulimab: Serplulimab will be administered as an IV infusion.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Participants with histologically or cytologically confirmed ES-SCLC.
* Fully understand the study and voluntarily sign the informed consent form;
* Male or female 18\~75 years of age;
* Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1;
* Life expectancy ≥ 3 months;
Exclusion Criteria:
* Participants were deemed unsuitable for participating in the study by the investigator for any reason.
Primary outcome measure(s)
Number of Participants Experiencing Dose-limiting toxicities (DLTs) — Up to Day 28
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) — Up to 2 Years
Trial sites (1)
Facility
City
Region
Status
Shanghai Chest Hospital
Shanghai
Shanghai Municipality
Recruiting
More Suzhou Zelgen Biopharmaceuticals Co.,Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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