Clinical Trials in South Korea / NCT06021483
Recruiting
Observational
Observational Study to Evaluate the Safety and Efficacy of Zepzelca™ Injection
NCT06021483 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
SCLC
Study 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 management plans.
Eligibility
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.
Primary outcome measure(s)
- ORR (Overall Response Rate) — 6 months after the start of administration
Percentage of subjects who reached complete remission (CR) and partial remission (PR)
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Seoul National University Boramae Medical Center | Seoul | South Korea | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06021483 on ClinicalTrials.gov ↗ ← All trials in South Korea