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

RECRUITINGSponsored by Boryung Pharmaceutical Co., Ltd
Actively Recruiting
SponsorBoryung Pharmaceutical Co., Ltd
Started2023-08-16
Est. completion2025-09
Eligibility
Age19 Years+
Healthy vol.Accepted

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

Age: 19 Years+Healthy volunteers accepted
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.

Conditions3

CancerLung CancerSCLC

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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