Small-cell Lung Cancer
Conditions
Brief summary
The main objective is to compare ZG006 with Investigator-Selected Chemotherapy on prolonging overall survival (OS).
Interventions
DRUGZG006
ZG006 will be administered as an intravenous (IV) infusion.
DRUGTopotecan
Topotecan will be administered per local standard of care
Sponsors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* Participants were deemed unsuitable for participating in the study by the investigator for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | Up to approximately 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events (AEs) | Up to approximately 3 years |
| Serum Concentrations of ZG006 | Up to approximately 3 years |
Countries
China
Contacts
Primary ContactHewen Yin
Outcome results
None listed