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NCT Number: NCT06247280

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

NSCLC

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kyungpook National University Chilgok Hospital, Chilgok, Daegu, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. PFS

    Time frame: 12months, 18months, 24months, 36months

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

  4. DFS

    Time frame: 12months, 18months, 24months, 36months

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

Secondary outcomes

  1. Diagnosis Test Method

    Time frame: up to 36months

    Frequency of diagnostic test methods according various clinical samples

  2. Diagnosis Test Method

    Time frame: up to 36months

    Proportion of diagnostic test methods according various clinical samples

  3. OS(Overall survival)

    Time frame: up to 36months

    Exploration of clinical outcomes according to treatment modality in NSCLC patients with EGFR mutation

  4. ORR(overall response rate)

    Time frame: up to 36months

    Exploration of clinical outcomes according to treatment modality in NSCLC patients with EGFR mutation

  5. DoR (duration of response)

    Time frame: up to 36months

    Exploration of clinical outcomes according to treatment modality in NSCLC patients with EGFR mutation

  6. DCR (disease control rate)

    Time frame: up to 36months

    Exploration of clinical outcomes according to treatment modality in NSCLC patients with EGFR mutation

  7. TTF (time to treatment failure)

    Time frame: up to 36months

    Exploration of clinical outcomes according to treatment modality in NSCLC patients with EGFR mutation

  8. TTNF (time to next treatment)

    Time frame: up to 36months

    Exploration of clinical outcomes according to treatment modality in NSCLC patients with EGFR mutation

  9. Analysis of metastatic sites and treatment patterns (especially brain and bone metastasis)

    Time frame: up to 36months

    Exploration of clinical characteristics and metastatic patterns in NSCLC patients with EGFR mutation

  10. Adverse event profiles

    Time frame: up to 36months

    Adverse event profiles after lazertinib administration

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Collaborators

  • The Korean Academy of Tuberculosis and Respiratory Diseases

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 7, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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