NCT06021483Recruiting
Observational Study to Evaluate the Safety and Efficacy of Zepzelca™ Injection
Observational Study to Evaluate the Safety and Efficacy of Zepzelca™ Injection (Lurbinectedin) in Patients With Metastatic Small Cell Lung Cancer (SCLC) in Real-World Practice
Source: ClinicalTrials.gov · Last updated 16 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 28 Aug 2023
- Start date
- 16 Aug 2023
- Primary completion date
- Sept 2025
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Diseases
- Lung cancer
- NCT number
- NCT06021483
What you commit to
- Study type: Observational
- Planned participants: 300
- From 16 Aug 2023 to the primary completion date, Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with no prior history of platinum-based anticancer chemotherapy for cancer treatment
- 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)
Other illness
- Patients with a history of hypersensitivity reactions to this drug or its components
Other
- Pregnant, potentially pregnant, or lactating women
- Patients who are judged by the principle Investigator or sub-Investigator to be ineligible to participate in the study.
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Boramae Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.