SCLCNCT06021483
Observational Study to Evaluate the Safety and Efficacy of Zepzelca™ Injection
An observational study of SCLC, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- SCLC
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Aug 2023to Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients With Metastatic SCLC who have failed first-line platinum-based chemotherapy
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Boramae Medical Center
Seoul
Ki-Hwan Kim, M.D., Ph.D.
About this study
Official title: Observational Study to Evaluate the Safety and Efficacy of Zepzelca™ Injection (Lurbinectedin) in Patients With Metastatic Small Cell Lung Cancer (SCLC) in Real-World Practice
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.
- Conditions
- SCLC
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR (Overall Response Rate)
Percentage of subjects who reached complete remission (CR) and partial remission (PR)
Measured: 6 months after the start of administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start16 Aug 2023
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCLCStudies of the same condition, open and under way.
- More trials run by Boryung Pharmaceutical Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021483
- Sponsor's protocol ID
- BR-LTD-OS-401
- Status last verified
- Sep 2025
- First submitted
- 28 Aug 2023
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Evaluate the Safety and Efficacy of Zepzelca™ Injection (Lurbinectedin) in Patients With Metastatic Small Cell Lung Cancer (SCLC) in Real-World Practice
- ClinicalTrials.gov ID
- NCT06021483
- Acronym / sponsor ID
- BR-LTD-OS-401
- Conditions
- SCLC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 16 Aug 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients With Metastatic SCLC who have failed first-line platinum-based chemotherapy
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ORR (Overall Response Rate)
Time frame: 6 months after the start of administration
Percentage of subjects who reached complete remission (CR) and partial remission (PR)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SCLC, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shinyoung Oh (+82-2-708-8000, syoh@boryung.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (Overall Response Rate) (time frame: 6 months after the start of administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.