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Recruiting

NCT Number: NCT06021483

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

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.

Recruiting

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Key information

Conditions

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Boramae Medical Center

Seoul, South Korea

Location status: Recruiting

Location contact

Ki-Hwan Kim, M.D., Ph.D.

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. ORR (Overall Response Rate)

    Time frame: 6 months after the start of administration

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

Other outcomes

  1. SAE & SADR Incidence Rate

    Time frame: 6 months after the start of administration

    Serious Adverse Event & Serious Adverse Drug Reaction Incidence Rate

Study contacts

Contact information is provided by the study sponsor or research team.

Shinyoung Oh

CONTACT

[email protected]

+82-2-708-8000

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 1, 2023
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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