A Phase 2 interventional study of Lazertinib group in NSCLC, sponsored by Sehhoon Park. Active, not recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Sehhoon Park · Phase 2, Interventional, and Treatment
The primary objective is to evaluate the efficacy/safety of lazertinib and to explore the resistance mechanism of lazertinib as first-line in patients with NSCLC harboring activating EGFR mutations.
As the 3rd generation EGFR TKI become a standard treatment option for the 1st line therapy in EGFR mutated patients, necessity for evaluating resistant mechanism to determine the matched subsequent therapeutic option has been highlighted. The idea of understanding the exact resistance mechanism to 1st line 3rd generation EGFR TKI treatment is emphasized based on the observation that resistance mechanism is different based on osimertinib used as 1st line or 2nd line treatment.6,7 Although resistance mechanisms to lazertinib in patients with prior EGFR TKI treatment have been studied, there are no current data available regarding the resistance mechanism after first-line lazertinib treatment.
Based on this observation, PI designed this study to elucidate the efficacy/safety of Lazertinib and to explore resistance mechanisms of 1st line lazertinib treatment in NSCLC patients with activating EGFR mutation.
Sehhoon Park is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adequate organ function.
Exclusion Criteria:
Lazertinib 240mg daily (1 cycle of 21 days)
Drug: Lazertinib group
Lazertinib 240mg, Once, po, daily (1 cycle of 21 days)
Also known as: Leclaza
progression-free survival
C1D1 until the date of objective disease progression or death
Time frame: through study completion, an average of 18.0 month
Resistance mechanism analysis
The mutation profile of baseline and at the timepoint of resistance will be evaluated using tissue and cfDNA
Time frame: Screening, Discontiunuation Visit
Objective response rate (ORR)
as the percentage of patients with measurable disease with at least one visit response of complete response (CR) or partial response (PR)
Time frame: through study completion, an average of 18.0 month
Duration of Response (DoR)
as the time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first
Time frame: through study completion, an average of 18.0 month
Disease control rate (DCR)
as the percentage of patients who have a best overall response of CR or PR or stable disease (SD at ≥ 6 weeks, prior to any PD event)
Time frame: through study completion, an average of 18.0 month
Overall survival (OS)
s the time from the date of C1D1 until the date of death due to any cause
Time frame: through study completion, an average of 18.0 month
intracranial PFS (iPFS)
as the time from C1D1 until the date of objective intracranial disease progression or death whichever comes first in patients for the iFAS
Time frame: through study completion, an average of 18.0 month
intracranial ORR (iORR)
as the percentage of patients who have at least 1 CR or PR in intracranial lesion, according to RECIST v1.1 prior to disease progression in patients who have at least one measurable intracranial lesion at baseline
Time frame: through study completion, an average of 18.0 month
intracranial DCR (iDCR)
as the percentage of patients who have a best intracranial overall response of CR or PR or SD in patients who have at least one measurable intracranial lesion at baseline
Time frame: through study completion, an average of 18.0 month
Plan to share: No
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This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Sehhoon Park