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

SCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06021483
• Other study ID #: BR-LTD-OS-401
• Status: Recruiting
• Start date: August 16, 2023
• Est. completion date: September 2025

Study information

• Verified date: August 2023
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: Shinyoung Oh
• Phone: +82-2-708-8000
• Email: syoh[@]boryung.co.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• SCLC

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Boramae Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	SAE & SADR Incidence Rate	Serious Adverse Event & Serious Adverse Drug Reaction Incidence Rate	6 months after the start of administration
Primary	ORR (Overall Response Rate)	Percentage of subjects who reached complete remission (CR) and partial remission (PR)	6 months after the start of administration