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NCT06247280 Clinical Trial

Korean Registry of Non-Small Cell Lung Cancer Patients With EGFR Mutation

NSCLC Clinical Trial

Official title:
Multicenter Prospective and Retrospective Cohort Study in Non-small Cell Lung Cancer Patients With EGFR Mutation: Korean EGFR Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06247280
Other study ID # YMC048
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 24, 2022
Est. completion date December 31, 2026

Study information
Verified date June 2024
Source Yuhan Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 2001
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: 1. Adults over 20-year-old with Korean nationality 2. A person who voluntarily signed the informed consent form for this study 3. 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. Exclusion Criteria: 1. A person who is not confirmed NSCLC histologically or cytologically. 2. A person who doesn't consent to the study. 3. A person who is unable to complete the study judged by the investigator.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of The Catholic Univ. of Korea Bucheon ST. Mary's Hospital Bucheon Gyeonggido
Korea, Republic of Soon Chun Hyang University Hospital Bucheon Bucheon-si Gyeonggi-do
Korea, Republic of Inje University Busan Paik Hospital Busan
Korea, Republic of Inje University Haeundae Paik Hospital Busan
Korea, Republic of Kosin University Gospel Hospital Busan
Korea, Republic of Pusan National University Yangsan Hospital Busan
Korea, Republic of Samsung Changwon Hospital Busan
Korea, Republic of Changwon Gyeongsang National University Hospital Changwon
Korea, Republic of Kyungpook National University Chilgok Hospital Chilgok Daegu
Korea, Republic of Hallym Univ. Medical Center. Chuncheon Chuncheon Gangwon
Korea, Republic of Daegu Catholic University Medical Center Daegu
Korea, Republic of Keimyung University Dongsan Hospital Daegu
Korea, Republic of Yeungnam University Medical Center Daegu
Korea, Republic of Chungnam National University Hospital Daejeon
Korea, Republic of Konyang Univ. Hospital Daejeon
Korea, Republic of Cheonnam National University Hwasun Hospital Hwasun
Korea, Republic of Wonkwang University Hospital Iksan Jeonbuk
Korea, Republic of Inha University Hospital Incheon
Korea, Republic of The Catholic University of Korea Incheon St.Mary's Hospital Incheon
Korea, Republic of Pusan National University Hospital Pusan
Korea, Republic of Asan Medical Center, University of Ulsan Seoul
Korea, Republic of Catholic Yeouido Sungmo Hospital Seoul
Korea, Republic of Chung-Ang University Hospital Seoul
Korea, Republic of Gangnam Severance Hospital Seoul
Korea, Republic of Hallym UNIV. Medical Center Seoul
Korea, Republic of Hanyang University Hospital Seoul
Korea, Republic of Inje University Sanggye Paik Hospital Seoul
Korea, Republic of Konkuk unversity hospital Seoul
Korea, Republic of Korea University Anam Hospital Seoul
Korea, Republic of Korea University Guro Hospital Seoul
Korea, Republic of Kyunghee university hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Severance Hospital, Yonsei University Seoul
Korea, Republic of Soon Chun Hyang University Hospital Seoul Seoul
Korea, Republic of The Catholic University Of Korea Seoul St. Mary's Hospital Seoul
Korea, Republic of The Catholic University of Korea, Eunpyeong St. Mary's Hospital Seoul
Korea, Republic of The Catholic University of Korea Uijeongbu St. Mary's Hospital Uijeongbu Gyeonggi-do
Korea, Republic of Wonju Severance Christian Hospital Wonju Gangwon-do
Korea, Republic of Yongin Severance Hospital Yongin

Sponsors (2)
Lead Sponsor Collaborator
Yuhan Corporation The Korean Academy of Tuberculosis and Respiratory Diseases

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical characteristics of NSCLC patients with EGFR mutation Analysis of clinical characteristics and clinical outcomes in NSCLC patients with EGFR mutation 12months, 18months, 24months, 36months
Primary Clinical outcome of NSCLS patients with EGFR mutation Analysis of clinical characteristics and clinical outcomes in NSCLC patients with EGFR mutation 12months, 18months, 24months, 36months
Primary PFS PFS underwent palliative therapy according to stages in NSCLC patients with EGFR mutation 12months, 18months, 24months, 36months
Primary DFS DFS in patients underwent definitive therapy according to stages in NSCLC patients with EGFR mutation 12months, 18months, 24months, 36months
Secondary Diagnosis Test Method Frequency of diagnostic test methods according various clinical samples up to 36months
Secondary Diagnosis Test Method Proportion of diagnostic test methods according various clinical samples up to 36months
Secondary OS(Overall survival) Exploration of clinical outcomes according to treatment modality in NSCLC patients with EGFR mutation up to 36months
Secondary ORR(overall response rate) Exploration of clinical outcomes according to treatment modality in NSCLC patients with EGFR mutation up to 36months
Secondary DoR (duration of response) Exploration of clinical outcomes according to treatment modality in NSCLC patients with EGFR mutation up to 36months
Secondary DCR (disease control rate) Exploration of clinical outcomes according to treatment modality in NSCLC patients with EGFR mutation up to 36months
Secondary TTF (time to treatment failure) Exploration of clinical outcomes according to treatment modality in NSCLC patients with EGFR mutation up to 36months
Secondary TTNF (time to next treatment) Exploration of clinical outcomes according to treatment modality in NSCLC patients with EGFR mutation up to 36months
Secondary 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 up to 36months
Secondary Adverse event profiles Adverse event profiles after lazertinib administration up to 36months
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