NSCLC
Conditions
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.
Interventions
None listed
Sponsors
The Korean Academy of Tuberculosis and Respiratory Diseases
Yuhan Corporation
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| PFS | 12months, 18months, 24months, 36months | PFS underwent palliative therapy according to stages 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
| Measure | Time frame | Description |
|---|---|---|
| DCR (disease control rate) | 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 |
| Diagnosis Test Method | up to 36months | Frequency of diagnostic test methods according various clinical samples |
| 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 |
| Adverse event profiles | up to 36months | Adverse event profiles after lazertinib administration |
| TTNF (time to next treatment) | up to 36months | Exploration of clinical outcomes according to treatment modality 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 |
| ORR(overall response rate) | up to 36months | Exploration of clinical outcomes according to treatment modality in NSCLC patients with EGFR mutation |
| DoR (duration of response) | up to 36months | Exploration of clinical outcomes according to treatment modality in NSCLC patients with EGFR mutation |
Countries
South Korea
Outcome results
None listed