Clinical trial NCT06247280: Korean Registry of Non-Small Cell Lung Cancer Patients with EGFR Mutation
Official title: Multicenter Prospective and Retrospective Cohort Study in Non-small Cell Lung Cancer Patients with EGFR Mutation: Korean EGFR Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: NSCLC
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
Collaborators: name: The Korean Academy of Tuberculosis and Respiratory Diseases
First posted: 2024-02-07
Enrollment: 2001
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical characteristics of NSCLC patients with EGFR mutation
timeFrame: 12months, 18months, 24months, 36months
measure: Clinical outcome of NSCLS patients with EGFR mutation
timeFrame: 12months, 18months, 24months, 36months
measure: PFS
timeFrame: 12months, 18months, 24months, 36months
measure: DFS
timeFrame: 12months, 18months, 24months, 36months
Secondary outcomes:
measure: Diagnosis Test Method
timeFrame: up to 36months
measure: Diagnosis Test Method
timeFrame: up to 36months
measure: OS(Overall survival)
timeFrame: up to 36months
measure: ORR(overall response rate)
timeFrame: up to 36months
measure: DoR (duration of response)
timeFrame: up to 36months
measure: DCR (disease control rate)
timeFrame: up to 36months
measure: TTF (time to treatment failure)
timeFrame: up to 36months
measure: TTNF (time to next treatment)
timeFrame: up to 36months
measure: Analysis of metastatic sites and treatment patterns (especially brain and bone metastasis)
timeFrame: up to 36months
measure: Adverse event profiles
timeFrame: up to 36months
Other outcomes:
Locations:
city: Chilgok
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
state: Daegu
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
state: Gangwon-do
city: Chuncheon
country: Korea, Republic of
facility: Hallym Univ. Medical Center. Chuncheon
state: Gangwon
city: Bucheon-si
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
state: Gyeonggi-do
city: Uijeongbu
country: Korea, Republic of
facility: The Catholic University of Korea Uijeongbu St. Mary's Hospital
state: Gyeonggi-do
city: Bucheon
country: Korea, Republic of
facility: The Catholic Univ. of Korea Bucheon ST. Mary's Hospital
state: Gyeonggido
city: Iksan
country: Korea, Republic of
facility: Wonkwang University Hospital
state: Jeonbuk
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Busan
country: Korea, Republic of
facility: Samsung Changwon Hospital
city: Changwon
country: Korea, Republic of
facility: Changwon Gyeongsang National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Konyang Univ. Hospital
city: Hwasun
country: Korea, Republic of
facility: Cheonnam National University Hwasun Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea Incheon St.Mary's Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Eunpyeong St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University
city: Seoul
country: Korea, Republic of
facility: The Catholic University Of Korea Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, University of Ulsan
city: Seoul
country: Korea, Republic of
facility: Catholic Yeouido Sungmo Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym UNIV. Medical Center
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggye Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk unversity hospital
city: Seoul
country: Korea, Republic of
facility: Kyunghee university hospital
city: Seoul
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Seoul
city: Yongin
country: Korea, Republic of
facility: Yongin Severance Hospital
Study officials:
affiliation: Yuhan Corporation
name: Sae Young Lee
role: STUDY_DIRECTOR
References: