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

NCT06247280 | Active Not Recruiting

• 1 other identifier: YMC048
• Study Type: observational
• Target: 2,001
• Locations: 1 country
• Sites: 39

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.

Conditions

NSCLC

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• PFS

  PFS underwent palliative therapy according to stages in NSCLC patients with EGFR mutation

  12months, 18months, 24months, 36months

• DFS

  DFS in patients underwent definitive therapy according to stages in NSCLC patients with EGFR mutation

  12months, 18months, 24months, 36months

Secondary Outcomes (10)

• Diagnosis Test Method

  up to 36months

• Diagnosis Test Method

  up to 36months

• OS(Overall survival)

  up to 36months

• ORR(overall response rate)

  up to 36months

• DoR (duration of response)

  up to 36months

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuhan Corporation: lead
• The Korean Academy of Tuberculosis and Respiratory Diseases: collaborator

Study Sites (39)

Kyungpook National University Chilgok Hospital

Chilgok, Daegu, South Korea

Location

Hallym Univ. Medical Center. Chuncheon

Chuncheon, Gangwon-do, South Korea

Location

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Location

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, Gyeonggi-do, 14584, South Korea

Location

The Catholic University of Korea Uijeongbu St. Mary's Hospital

Uijeongbu-si, Gyeonggi-do, 11765, South Korea

Location

The Catholic Univ. of Korea Bucheon ST. Mary's Hospital

Bucheon-si, Gyeonggido, South Korea

Location

Wonkwang University Hospital

Iksan, Jeollabuk-do, South Korea

Location

Catholic Yeouido Sungmo Hospital

Seoul, Seoul, South Korea

Location

Inje University Haeundae Paik Hospital

Busan, 48108, South Korea

Location

Kosin University Gospel Hospital

Busan, 49267, South Korea

Location

Inje University Busan Paik Hospital

Busan, South Korea

Location

Pusan National University Yangsan Hospital

Busan, South Korea

Location

Samsung Changwon Hospital

Busan, South Korea

Location

Changwon Gyeongsang National University Hospital

Changwon, South Korea

Location

Yeungnam University Medical Center

Daegu, 42415, South Korea

Location

Daegu Catholic University Medical Center

Daegu, South Korea

Location

Keimyung University Dongsan Hospital

Daegu, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

Konyang Univ. Hospital

Daejeon, South Korea

Location

Cheonnam National University Hwasun Hospital

Hwasun, South Korea

Location

Inha University Hospital

Incheon, South Korea

Location

The Catholic University of Korea Incheon St.Mary's Hospital

Incheon, South Korea

Location

Pusan National University Hospital

Pusan, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

Seoul, 03312, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Chung-Ang University Hospital

Seoul, 06973, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Severance Hospital, Yonsei University

Seoul, 120-752, South Korea

Location

The Catholic University Of Korea Seoul St. Mary's Hospital

Seoul, 137-701, South Korea

Location

Asan Medical Center, University of Ulsan

Seoul, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Hallym UNIV. Medical Center

Seoul, South Korea

Location

Hanyang University Hospital

Seoul, South Korea

Location

Inje University Sanggye Paik Hospital

Seoul, South Korea

Location

Konkuk unversity hospital

Seoul, South Korea

Location

Kyunghee university hospital

Seoul, South Korea

Location

Soon Chun Hyang University Hospital Seoul

Seoul, South Korea

Location

Yongin Severance Hospital

Yŏngin, South Korea

Location

Study Officials

• Sae Young Lee

  Yuhan Corporation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: February 7, 2024
• Study Start: June 24, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

KR (39)