Study Comparing ZG006 With Investigator-Selected Chemotherapy in Participants With Relapsed Small Cell Lung Cancer
Not Applicable
Not yet recruiting
- Conditions
- Small-cell Lung Cancer
- Interventions
- Registration Number
- NCT07189455
- Lead Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Brief Summary
The main objective is to compare ZG006 with Investigator-Selected Chemotherapy on prolonging overall survival (OS).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 420
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ZG006 ZG006 ZG006 10 mg Q2W Investigator-Selected Chemotherapy Topotecan Investigator-selected chemotherapy, such as topotecan.
- Primary Outcome Measures
Name Time Method Overall Survival (OS) Up to approximately 3 years
- Secondary Outcome Measures
Name Time Method Serum Concentrations of ZG006 Up to approximately 3 years Number of participants with adverse events (AEs) Up to approximately 3 years
Trial Locations
- Locations (1)
Shanghai Chest Hospital
🇨🇳Shanghai, Shanghai Municipality, China
Shanghai Chest Hospital🇨🇳Shanghai, Shanghai Municipality, China