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

Sponsor
Boryung Pharmaceutical Co., Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06021483
Collaborator
(none)
300
Enrollment
1
Location
24.5
Anticipated Duration (Months)
12.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Aug 16, 2023
    Anticipated Primary Completion Date :
    Sep 1, 2025
    Anticipated Study Completion Date :
    Sep 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. ORR (Overall Response Rate) [6 months after the start of administration]

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

    Other Outcome Measures

    1. SAE & SADR Incidence Rate [6 months after the start of administration]

      Serious Adverse Event & Serious Adverse Drug Reaction Incidence Rate

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Boramae Medical Center Seoul Korea, Republic of

    Sponsors and Collaborators

    • Boryung Pharmaceutical Co., Ltd

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Boryung Pharmaceutical Co., Ltd
    ClinicalTrials.gov Identifier:
    NCT06021483
    Other Study ID Numbers:
    • BR-LTD-OS-401
    First Posted:
    Sep 1, 2023
    Last Update Posted:
    Sep 1, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Sep 1, 2023