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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-16

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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SCLC

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No