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Lazertinib for NSCLC Harboring Activating EGFR Mutations in TKI naïve Patients

NCT ID: NCT05463224

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-02

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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NSCLC

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A single-arm, phase II single-center trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lazertinib group

Lazertinib 240mg daily (1 cycle of 21 days)

Group Type EXPERIMENTAL

Lazertinib group

Intervention Type DRUG

Lazertinib 240mg, Once, po, daily (1 cycle of 21 days)

Interventions

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Lazertinib group

Lazertinib 240mg, Once, po, daily (1 cycle of 21 days)

Intervention Type DRUG

Other Intervention Names

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Leclaza

Eligibility Criteria

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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.

* Available to provide the adequate tissue and blood for the genomic tests- At least 15 unstained slide and 20 cc of blood at baseline (mandatory) and disease progression.
* 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

* Previously treatment with any kind of EGFR TKI (Previously chemotherapy treated patients is allowed)
* Any concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of study drug. (allowed for participation if investigator decided that previous malignancy is cured and not need for any additional treatment)
* Uncontrolled central nervous system metastases- patient with asymptomatic brain metastases or CNS symptom manageable with TKI and evaluated by investigator can be enrolled.
* Spinal cord compression, leptomeningeal carcinomatosis
* Uncontrolled systemic illness, including uncontrolled hypertension, active bleeding, or active infection
* Radiotherapy with a wide field of radiation within 2 weeks or radiotherapy with a limited field of radiation (localized radiotherapy or gamma knife surgery) for palliation within 1 week
* Any unresolved toxicities from prior therapy, greater than CTCAE grade 1
* Mean QT interval corrected for heart rate (QTc) ≥ 470 ms
* No measurable lesion
* Unable to swallow the product due to refractory nausea, vomiting or chornic gastrointestinal disease.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Se-Hoon Lee

OTHER

Sponsor Role lead

Responsible Party

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Se-Hoon Lee

M.D, Ph.D. Principal Investigator, Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Se-Hoon Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, Gangnamgu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2022-09-029

Identifier Type: -

Identifier Source: org_study_id