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

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

Recruiting
19 years and older
All
Phase N/A

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Overview

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

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.

Study details
    SCLC

NCT06021483

Boryung Pharmaceutical Co., Ltd

26 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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