Observational Study to Evaluate the Safety and Efficacy of Zepzelca™ Injection
ConditionSCLC
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorBoryung Pharmaceutical Co., Ltd
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
Patients With Metastatic SCLC who have failed first-line platinum-based chemotherapy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
ORR (Overall Response Rate)
Percentage of subjects who reached complete remission (CR) and partial remission (PR)
Time frame
6 months after the start of administrationOther outcomes
1
SAE & SADR Incidence Rate
Serious Adverse Event \& Serious Adverse Drug Reaction Incidence Rate
Time frame
6 months after the start of administrationSponsors and contacts
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Source ClinicalTrials.gov