NCT06021483 Observational Study to Evaluate the Safety and Efficacy of Zepzelca™ Injection
| NCT ID | NCT06021483 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boryung Pharmaceutical Co., Ltd |
| Condition | SCLC |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-08-16 |
| Primary Completion | 2025-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2023-08-16 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 management plans.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06021483 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying SCLC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06021483 currently recruiting?
Yes, NCT06021483 is actively recruiting participants. Contact the research team at syoh@boryung.co.kr for enrollment information.
Where is the NCT06021483 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06021483 clinical trial?
NCT06021483 is sponsored by Boryung Pharmaceutical Co., Ltd. The trial plans to enroll 300 participants.