Observational Study to Evaluate the Safety and Efficacy of Zepzelca™ Injection
Recruiting · NCT06021483 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →What this trial is about
The purpose of this study is to evaluate the safety and efficacy of Zepzelca™ inj. in real-world practice and to investigate important identified risks and gaps in information related to risk management plans.
Who can take part
Age range
19 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Patients who voluntarily provide written consent for personal information collection and utilization after receiving an explanation about the objective and methods of the study
- Patients who have received or are scheduled to receive Zepzelca™ inj., according to domestic approval indications
- Patients with metastatic SCLC who have failed first-line platinum-based chemotherapy
Exclusion criteria
- Patients with no prior history of platinum-based anticancer chemotherapy for cancer treatment
- Patients with a history of hypersensitivity reactions to this drug or its components
- Pregnant, potentially pregnant, or lactating women
- Patients currently participating in another clinical trial (drug or medical device) or planning to participate in another clinical trial during the study period (except for non-interventional clinical studies or cases where the clinical trial drug administration has ended and only follow-up is remaining)
- Patients who are judged by the principle Investigator or sub-Investigator to be ineligible to participate in the study.
Where it is running
1 location listed.
- Seoul National University Boramae Medical Center - Seoul, South Korea