RecruitingPhase 3NCT07189455
Study Comparing ZG006 With Investigator-Selected Chemotherapy in Participants With Relapsed Small Cell Lung Cancer
A Multicenter, Randomized, Controlled, Open-Label Phase III Study Evaluating the Efficacy and Safety of ZG006 for Injection Compared With Investigator-Selected Chemotherapy in Participants With Relapsed Small Cell Lung Cancer
Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Enrollment
420 participants
Start Date
Dec 12, 2025
Study Type
INTERVENTIONAL
Summary
The main objective is to compare ZG006 with Investigator-Selected Chemotherapy on prolonging overall survival (OS).
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria5
- 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;
- Histologically or cytologically confirmed Small Cell Lung Cancer.
Exclusion Criteria1
- Participants were deemed unsuitable for participating in the study by the investigator for any reason.
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Interventions
DRUGZG006
ZG006 will be administered as an intravenous (IV) infusion.
DRUGTopotecan
Topotecan will be administered per local standard of care
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07189455