Evaluating the safety and effectiveness of Zepzelca™ injection for small cell lung cancer
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
This study is testing if the Zepzelca™ injection is safe and effective for people with small cell lung cancer that hasn't improved after their first treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Boryung Pharmaceutical Co., Ltd Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06021483 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and efficacy of Zepzelca™ injection in real-world clinical practice for patients with metastatic small cell lung cancer (SCLC) who have not responded to first-line platinum-based chemotherapy. The study will also investigate identified risks and gaps in information related to risk management plans. Participants will provide consent for the collection and use of their personal information after being informed about the study's objectives and methods.
Who should consider this trial
Good fit: Ideal candidates include patients with metastatic SCLC who have previously failed first-line platinum-based chemotherapy and are scheduled to receive Zepzelca™ injection.
Not a fit: Patients who have not undergone prior platinum-based chemotherapy or have a history of hypersensitivity to Zepzelca™ will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness and safety of Zepzelca™ for patients with SCLC.
How similar studies have performed: While this study is observational and focuses on real-world data, similar studies evaluating the efficacy of treatments in SCLC have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Seoul
- Seoul National University Boramae Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Shinyoung Oh
- Email: syoh@boryung.co.kr
- Phone: +82-2-708-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.