NSCLCNCT06247280
Korean Registry of Non-Small Cell Lung Cancer Patients with EGFR Mutation
An observational study of NSCLC, run by Yuhan Corporation at 39 sites in South Korea.
Trial summary
Korean Registry of Non-Small Cell Lung Cancer Patients with EGFR mutation to collect and analyze the patient's clinical features, diagnosis, and treatment results. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- NSCLC
- How many people
- 2,001 participants
- Where
- 39 sitesSouth Korea
- Study dates
- 24 Jun 2022to 31 Dec 2026
- How long will I take part?
- 5 Years
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with non-small cell lung cancer of any stage with an EGFR mutation newly diagnosed after the date of IRB approval, or patients who started EGFR-targeted therapy for the first time after 2021-01-01 with metastatic or recurrent EGFR mutation non-small cell lung cancer.
Who may be able to join
- Adults over 20-year-old with Korean nationality
- A person who voluntarily signed the informed consent form for this study
- All stage Non small cell lung cancer patients with EGFR mutation or Metastatic or recurred EGFR mutated NSCLC patients started with EGFR TKI treatment from 2021-01-01.
Who cannot join
- A person who is not confirmed NSCLC histologically or cytologically.
- A person who doesn't consent to the study.
- A person who is unable to complete the study judged by the investigator.
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
South Korea39 sites
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, Gyeonggi-do, 14584
The Catholic Univ. of Korea Bucheon ST. Mary's Hospital
Bucheon-si, Gyeonggido
Inje University Haeundae Paik Hospital
Busan, 48108
Kosin University Gospel Hospital
Busan, 49267
Inje University Busan Paik Hospital
Busan
Pusan National University Yangsan Hospital
Busan
Samsung Changwon Hospital
Busan
Changwon Gyeongsang National University Hospital
Changwon
Kyungpook National University Chilgok Hospital
Chilgok, Daegu
Hallym Univ. Medical Center. Chuncheon
Chuncheon, Gangwon-do
Yeungnam University Medical Center
Daegu, 42415
Daegu Catholic University Medical Center
Daegu
Keimyung University Dongsan Hospital
Daegu
Chungnam National University Hospital
Daejeon
Konyang Univ. Hospital
Daejeon
Cheonnam National University Hwasun Hospital
Hwasun
Wonkwang University Hospital
Iksan, Jeollabuk-do
Inha University Hospital
Incheon
The Catholic University of Korea Incheon St.Mary's Hospital
Incheon
Pusan National University Hospital
Pusan
Catholic Yeouido Sungmo Hospital
Seoul, Seoul
Korea University Anam Hospital
Seoul, 02841
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, 03312
Samsung Medical Center
Seoul, 06351
Chung-Ang University Hospital
Seoul, 06973
Korea University Guro Hospital
Seoul, 08308
Severance Hospital, Yonsei University
Seoul, 120-752
The Catholic University Of Korea Seoul St. Mary's Hospital
Seoul, 137-701
Asan Medical Center, University of Ulsan
Seoul
Gangnam Severance Hospital
Seoul
Hallym UNIV. Medical Center
Seoul
Hanyang University Hospital
Seoul
Inje University Sanggye Paik Hospital
Seoul
Konkuk unversity hospital
Seoul
Kyunghee university hospital
Seoul
Soon Chun Hyang University Hospital Seoul
Seoul
The Catholic University of Korea Uijeongbu St. Mary's Hospital
Uijeongbu-si, Gyeonggi-do, 11765
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do
Yongin Severance Hospital
Yŏngin
About this study
Official title: Multicenter Prospective and Retrospective Cohort Study in Non-small Cell Lung Cancer Patients with EGFR Mutation: Korean EGFR Registry
Korean Registry of Non-Small Cell Lung Cancer Patients with EGFR mutation to collect and analyze the patient's clinical features, diagnosis, and treatment results.
Read the detailed description
The Korean EGFR Registry is a prospective multicenter observational cohort study designed to enroll all stage EGFR-mutated non-small cell lung cancer (NSCLC) patients. However, due to the extended follow-up period required to confirm clinical outcomes, a retrospective cohort has been included. This retrospective cohort comprises patients with recurrent or metastatic NSCLC who began taking EGFR TKI after January 2021. The recruitment phase was planned to span 36 months, commencing in May 2022, with scheduled follow-up activities continuing until December 2026. The target enrollment for this study is set at 2,000 patients, with competitive enrollment to be carried out across 40 university hospitals in Korea.
- Conditions
- NSCLC
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical characteristics of NSCLC patients with EGFR mutation
Analysis of clinical characteristics and clinical outcomes in NSCLC patients with EGFR mutation
Measured: 12months, 18months, 24months, 36months
Clinical outcome of NSCLS patients with EGFR mutation
Analysis of clinical characteristics and clinical outcomes in NSCLC patients with EGFR mutation
Measured: 12months, 18months, 24months, 36months
PFS
PFS underwent palliative therapy according to stages in NSCLC patients with EGFR mutation
Measured: 12months, 18months, 24months, 36months
DFS
DFS in patients underwent definitive therapy according to stages in NSCLC patients with EGFR mutation
Measured: 12months, 18months, 24months, 36months
Secondary outcomes (10)
Diagnosis Test Method
Frequency of diagnostic test methods according various clinical samples
Measured: up to 36months
Diagnosis Test Method
Proportion of diagnostic test methods according various clinical samples
Measured: up to 36months
OS(Overall survival)
Exploration of clinical outcomes according to treatment modality in NSCLC patients with EGFR mutation
Measured: up to 36months
ORR(overall response rate)
Exploration of clinical outcomes according to treatment modality in NSCLC patients with EGFR mutation
Measured: up to 36months
DoR (duration of response)
Exploration of clinical outcomes according to treatment modality in NSCLC patients with EGFR mutation
Measured: up to 36months
DCR (disease control rate)
Exploration of clinical outcomes according to treatment modality in NSCLC patients with EGFR mutation
Measured: up to 36months
TTF (time to treatment failure)
Exploration of clinical outcomes according to treatment modality in NSCLC patients with EGFR mutation
Measured: up to 36months
TTNF (time to next treatment)
Exploration of clinical outcomes according to treatment modality in NSCLC patients with EGFR mutation
Measured: up to 36months
Analysis of metastatic sites and treatment patterns (especially brain and bone metastasis)
Exploration of clinical characteristics and metastatic patterns in NSCLC patients with EGFR mutation
Measured: up to 36months
Adverse event profiles
Adverse event profiles after lazertinib administration
Measured: up to 36months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start24 Jun 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 2,001 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Korean Academy of Tuberculosis and Respiratory Diseases
- Responsible party
- Sponsor
- Investigators
- Sae Young Lee, Study director, Yuhan Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247280
- Sponsor's protocol ID
- YMC048
- Status last verified
- Dec 2024
- First submitted
- 19 Jan 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective and Retrospective Cohort Study in Non-small Cell Lung Cancer Patients with EGFR Mutation: Korean EGFR Registry
- ClinicalTrials.gov ID
- NCT06247280
- Acronym / sponsor ID
- YMC048
- Conditions
- NSCLC
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,001 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Collaborators
- The Korean Academy of Tuberculosis and Respiratory Diseases
- Study start
- 24 Jun 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Feb 2024 (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.
Korean Registry of Non-Small Cell Lung Cancer Patients with EGFR mutation to collect and analyze the patient's clinical features, diagnosis, and treatment results.
Detailed description
The Korean EGFR Registry is a prospective multicenter observational cohort study designed to enroll all stage EGFR-mutated non-small cell lung cancer (NSCLC) patients. However, due to the extended follow-up period required to confirm clinical outcomes, a retrospective cohort has been included. This retrospective cohort comprises patients with recurrent or metastatic NSCLC who began taking EGFR TKI after January 2021. The recruitment phase was planned to span 36 months, commencing in May 2022, with scheduled follow-up activities continuing until December 2026. The target enrollment for this study is set at 2,000 patients, with competitive enrollment to be carried out across 40 university hospitals in Korea.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-small cell lung cancer of any stage with an EGFR mutation newly diagnosed after the date of IRB approval, or patients who started EGFR-targeted therapy for the first time after 2021-01-01 with metastatic or recurrent EGFR mutation non-small cell lung cancer.
Key inclusion criteria (3 listed)
- Adults over 20-year-old with Korean nationality
- A person who voluntarily signed the informed consent form for this study
- All stage Non small cell lung cancer patients with EGFR mutation or Metastatic or recurred EGFR mutated NSCLC patients started with EGFR TKI treatment from 2021-01-01.
Key exclusion criteria (3 listed)
- A person who is not confirmed NSCLC histologically or cytologically.
- A person who doesn't consent to the study.
- A person who is unable to complete the study judged by the investigator.
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
Clinical characteristics of NSCLC patients with EGFR mutation
Time frame: 12months, 18months, 24months, 36months
Analysis of clinical characteristics and clinical outcomes in NSCLC patients with EGFR mutation
Clinical outcome of NSCLS patients with EGFR mutation
Time frame: 12months, 18months, 24months, 36months
Analysis of clinical characteristics and clinical outcomes in NSCLC patients with EGFR mutation
PFS
Time frame: 12months, 18months, 24months, 36months
PFS underwent palliative therapy according to stages in NSCLC patients with EGFR mutation
DFS
Time frame: 12months, 18months, 24months, 36months
DFS in patients underwent definitive therapy according to stages in NSCLC patients with EGFR mutation
10 secondary outcomes
Diagnosis Test Method
Time frame: up to 36months
Diagnosis Test Method
Time frame: up to 36months
OS(Overall survival)
Time frame: up to 36months
ORR(overall response rate)
Time frame: up to 36months
DoR (duration of response)
Time frame: up to 36months
DCR (disease control rate)
Time frame: up to 36months
TTF (time to treatment failure)
Time frame: up to 36months
TTNF (time to next treatment)
Time frame: up to 36months
Analysis of metastatic sites and treatment patterns (especially brain and bone metastasis)
Time frame: up to 36months
Adverse event profiles
Time frame: up to 36months
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 6 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Sae Young Lee study director
Yuhan Corporation
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC, run by Yuhan Corporation at 39 sites 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 3 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: under way, not looking for participants, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical characteristics of NSCLC patients with EGFR mutation (time frame: 12months, 18months, 24months, 36months). The study lists 4 primary outcomes in all. 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 6 Dec 2024.