RecruitingNCT06021483

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

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

Sponsor

Boryung Pharmaceutical Co., Ltd

Enrollment

300 participants

Start Date

Aug 16, 2023

Study Type

OBSERVATIONAL

Conditions

SCLC

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.

Eligibility

Min Age: 19 Years

Inclusion Criteria3

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 Criteria5

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.