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

NCT06021483 | Recruiting

• 1 other identifier: BR-LTD-OS-401
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

SCLC

Outcome Measures

Primary Outcomes (1)

• ORR (Overall Response Rate)

  Percentage of subjects who reached complete remission (CR) and partial remission (PR)

  6 months after the start of administration

Other Outcomes (1)

• SAE & SADR Incidence Rate

  6 months after the start of administration

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients With Metastatic SCLC who have failed first-line platinum-based chemotherapy

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.

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

Seoul National University Boramae Medical Center

Seoul, South Korea

RECRUITING

Central Study Contacts

Shinyoung Oh

CONTACT

+82-2-708-8000; syoh@boryung.co.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 1, 2023
• Study Start: August 16, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

KR (1)