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

Launched by BORYUNG PHARMACEUTICAL CO., LTD · Aug 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a medication called Zepzelca™ injection for patients with small cell lung cancer (SCLC) who have not responded to initial chemotherapy treatments. The goal is to understand how well this drug works in real-world settings and to identify any potential risks associated with its use. The study is currently looking for participants who are adults aged 39 and older and who have received or are scheduled to receive Zepzelca™.

To be eligible, participants need to agree to share their personal information after learning about the study. They must have metastatic SCLC, which means the cancer has spread, and they should have already tried platinum-based chemotherapy without success. However, individuals who are pregnant, have had severe reactions to Zepzelca™, or are currently involved in other clinical trials cannot participate. If you join the study, you can expect to have your health monitored while you receive Zepzelca™, helping researchers gather important information about the treatment's safety and effectiveness in everyday use.

Gender

ALL

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.