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Recruiting Observational

Observational Study to Evaluate the Safety and Efficacy of Zepzelca™ Injection

NCT06021483 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2023-08-16
Last updated
2025-09-16

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

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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)

FacilityCityRegionStatus
Seoul National University Boramae Medical Center Seoul South Korea Recruiting
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