The first line Lazertinib treatment for metastatic EGFRm NSCLC; the real world evidence in South Korea
- Conditions
- Neoplasms
- Registration Number
- KCT0009698
- Lead Sponsor
- Hallym University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 500
1) Age = 18 years old and holding Korean (nationality) at the time of Informed consent
2) Voluntarily signed the informed consent form
However, WGS(whole genome sequencing) test will only conducted on individuals who have voluntarily singed a separated consent form.
3) Patients who are to initiate lazertinib as the first line treatment
? EGFR L858R or 19del mutation-positive stage IV NSCLC patients,
? or Patients with EGFR L858R or 19del mutation-positive NSCLC who relapsed to stage 4 after surgery and had no history of EGFR-TKI treatment (neoadjuvant/adjuvant chemotherapy/radiotherapy before/after surgery is allowed)
1) Age < 18 years old
2) histologically or cytologically not confirmed NSCLC
3) No EGFR L858R or 19del mutation
4) Not receiving lazertinib as first-line treatment
5) No agreement to participate in this study
6) Anticipated subject unable to complete the research as determined by the PI and Sub-I.
7) Patients enrolled in other studies related to lazertinib (Duplicate enrollment in other studies involving lazertinib was not allowed.)
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS)
- Secondary Outcome Measures
Name Time Method Objective response rate (ORR);Duration of Response (DoR);Disease Control Rate (DCR);Time to treatment discontinuation (TTD);intracranial Objective Response Rate (icORR);intracranial Duration of Response (icDoR);intracranial Disease Control Rate (icDCR);intracranial Progression Free Survival (icPFS);Time to First Subsequent Therapy (TFST);Time to 2nd Progression free survival (PFS2);Overall Survival (OS);1-Year, 2-Year, 3-Year survival rate;Quality of Life;Adverse Events