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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lazertinib group | Experimental | Lazertinib 240mg daily (1 cycle of 21 days) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lazertinib group | Drug | Lazertinib 240mg, Once, po, daily (1 cycle of 21 days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | C1D1 until the date of objective disease progression or death | 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 | Screening, Discontiunuation Visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | through study completion, an average of 18.0 month |
| Duration of Response (DoR) |
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Inclusion Criteria:
Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer which is not amenable to treatment with a curative aim (e.g. surgery or radiation). Patients who underwent curative intent surgery or definitive CRT and experience recurrence after 6 months are eligible.
Stage IIIC or IV by AJCC 8th edition
Confirmed EGFR mutations (exon 19 deletion, L858R)(The result from both cell-free DNA or tissue-based DNA from the local test is allowed.)
Age of 19 or more.
Performance status of Eastern Cooperative Oncology Group 0 to 2.
Expected minimum life expectancy of 12 weeks
Adequate organ function.
Agreed to perform re-biopsy at the timepoint of disease progression.
At least two weeks after the chemotherapy
Female subjects must either be of non-reproductive potential
Subject willing and able to comply with the protocol
Signed written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Se-Hoon Lee, MD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | Gangnamgu | 06351 | South Korea |
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| ID | Term |
|---|---|
| C000707992 | lazertinib |
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A single-arm, phase II single-center trial
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as the time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first
| 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) | 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 | 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 | 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 | 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 | through study completion, an average of 18.0 month |