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

Recruiting now

Conditions studied: SCLC

In brief

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.

Key facts

Study ID

NCT06021483

Run by

Boryung Pharmaceutical Co., Ltd

People needed

300

Starts

2023-08-16

Expected to finish

2025-09-01

Last updated by the study team

2025-09-16

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Seoul National University Boramae Medical Center — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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