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The first line Lazertinib treatment for metastatic EGFRm NSCLC; the real world evidence in South Korea

The first line Lazertinib treatment for metastatic EGFRm NSCLC; the real world evidence in South Korea

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0009698
Enrollment
500
Registered
2024-08-14
Start date
2024-08-29
Completion date
Unknown
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Hallym University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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.)

Design outcomes

Primary

MeasureTime frame
Progression-free survival (PFS)

Secondary

MeasureTime frame
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

Countries

Korea, Republic of

Contacts

Public ContactSeung Hun Jang

Hallym University Medical Center

chestor@hallym.or.kr+82-31-380-3719

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026