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

Recruiting

• Conditions: SCLC

• Registration Number: NCT06021483
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study Start: 2023-08-16
• Study First Submitted: 2023-08-28
• Study First Submitted QC: 2023-08-28
• Last Update Submitted: 2023-08-28
• Study First Posted: 2023-09-01
• Last Update Posted: 2023-09-01
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ORR (Overall Response Rate)	6 months after the start of administration	Percentage of subjects who reached complete remission (CR) and partial remission (PR)

Trial Locations

Locations (1)

Seoul National University Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of