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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06021483

Enrollment

300

Registered

2023-09-01

Start date

2023-08-16

Completion date

2025-09-30

Last updated

2025-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SCLC

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Other

Measure	Time frame	Description
SAE & SADR Incidence Rate	6 months after the start of administration	Serious Adverse Event & Serious Adverse Drug Reaction Incidence Rate

Countries

South Korea

Contacts

Primary ContactShinyoung Oh

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

Outcome results