Recruiting NCT07189455
Study Comparing ZG006 With Investigator-Selected Chemotherapy in Participants With Relapsed Small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ZG006, Topotecan.
- Who it may be relevant to
- Registry conditions: Small-cell Lung Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
The main objective is to compare ZG006 with Investigator-Selected Chemotherapy on prolonging overall survival (OS).
Interventions
- Drug ZG006
ZG006 will be administered as an intravenous (IV) infusion. - Drug Topotecan
Topotecan will be administered per local standard of care
Primary outcome measures
- Overall Survival (OS) [Time frame: Up to approximately 3 years]
Secondary outcome measures (2)
- Number of participants with adverse events (AEs) [Time frame: Up to approximately 3 years]
- Serum Concentrations of ZG006 [Time frame: Up to approximately 3 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Chest Hospital — Shanghai
Identifiers
NCT: NCT07189455 · ZG006-006