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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
View on ClinicalTrials.gov →
NCT06021483
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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Actively Recruiting
SponsorBoryung Pharmaceutical Co., Ltd
Started2023-08-16
Est. completion2025-09
Eligibility
Age19 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06021483