Korean Registry of Non-Small Cell Lung Cancer Patients with EGFR Mutation
- Conditions
- NSCLC
- Registration Number
- NCT06247280
- Lead Sponsor
- Yuhan Corporation
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2001
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical characteristics of NSCLC patients with EGFR mutation 12months, 18months, 24months, 36months Analysis of clinical characteristics and clinical outcomes in NSCLC patients with EGFR mutation
PFS 12months, 18months, 24months, 36months PFS underwent palliative therapy according to stages in NSCLC patients with EGFR mutation
Clinical outcome of NSCLS patients with EGFR mutation 12months, 18months, 24months, 36months Analysis of clinical characteristics and clinical outcomes in NSCLC patients with EGFR mutation
DFS 12months, 18months, 24months, 36months DFS in patients underwent definitive therapy according to stages in NSCLC patients with EGFR mutation
- Secondary Outcome Measures
Name Time Method DoR (duration of response) up to 36months Exploration of clinical outcomes according to treatment modality in NSCLC patients with EGFR mutation
TTF (time to treatment failure) up to 36months Exploration of clinical outcomes according to treatment modality in NSCLC patients with EGFR mutation
Analysis of metastatic sites and treatment patterns (especially brain and bone metastasis) up to 36months Exploration of clinical characteristics and metastatic patterns in NSCLC patients with EGFR mutation
OS(Overall survival) up to 36months Exploration of clinical outcomes according to treatment modality in NSCLC patients with EGFR mutation
Adverse event profiles up to 36months Adverse event profiles after lazertinib administration
Diagnosis Test Method up to 36months Proportion of diagnostic test methods according various clinical samples
DCR (disease control rate) up to 36months Exploration of clinical outcomes according to treatment modality in NSCLC patients with EGFR mutation
TTNF (time to next treatment) up to 36months Exploration of clinical outcomes according to treatment modality in NSCLC patients with EGFR mutation
ORR(overall response rate) up to 36months Exploration of clinical outcomes according to treatment modality in NSCLC patients with EGFR mutation
Trial Locations
- Locations (39)
Kyungpook National University Chilgok Hospital
🇰🇷Chilgok, Daegu, Korea, Republic of
Wonju Severance Christian Hospital
🇰🇷Wonju, Gangwon-do, Korea, Republic of
Hallym Univ. Medical Center. Chuncheon
🇰🇷Chuncheon, Gangwon, Korea, Republic of
Soon Chun Hyang University Hospital Bucheon
🇰🇷Bucheon-si, Gyeonggi-do, Korea, Republic of
The Catholic Univ. of Korea Bucheon ST. Mary's Hospital
🇰🇷Bucheon, Gyeonggido, Korea, Republic of
Wonkwang University Hospital
🇰🇷Iksan, Jeonbuk, Korea, Republic of
Kosin University Gospel Hospital
🇰🇷Busan, Korea, Republic of
Inje University Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Inje University Busan Paik 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
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Keimyung University Dongsan Hospital
🇰🇷Daegu, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Cheonnam National University Hwasun Hospital
🇰🇷Hwasun, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Konyang Univ. Hospital
🇰🇷Daejeon, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
The Catholic University of Korea Incheon St.Mary's Hospital
🇰🇷Incheon, Korea, Republic of
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University
🇰🇷Seoul, Korea, Republic of
The Catholic University Of Korea Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center, University of Ulsan
🇰🇷Seoul, Korea, Republic of
Catholic Yeouido Sungmo Hospital
🇰🇷Seoul, Korea, Republic of
Konkuk unversity hospital
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Hanyang University Hospital
🇰🇷Seoul, Korea, Republic of
Inje University Sanggye Paik Hospital
🇰🇷Seoul, Korea, Republic of
Kyunghee university hospital
🇰🇷Seoul, Korea, Republic of
Yongin Severance Hospital
🇰🇷Yongin, Korea, Republic of
Soon Chun Hyang University Hospital Seoul
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Uijeongbu St. Mary's Hospital
🇰🇷Uijeongbu, Gyeonggi-do, Korea, Republic of
Hallym UNIV. Medical Center
🇰🇷Seoul, Korea, Republic of