Status:
RECRUITING
Observational Study to Evaluate the Safety and Efficacy of Zepzelca™ Injection
Lead Sponsor:
Boryung Pharmaceutical Co., Ltd
Conditions:
SCLC
Eligibility:
All Genders
19+ years
Brief Summary
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 manageme...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 16 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06021483
Start Date
August 16 2023
End Date
September 1 2025
Last Update
September 16 2025
Active Locations (1)
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1
Seoul National University Boramae Medical Center
Seoul, South Korea