Impact of Modifying Lazertinib Doses on Effectiveness and Safety in Patients With EGFR‐Positive Advanced Lung Cancer: A Multicenter, Prospective Observational Cohort Study

ABSTRACT Introduction The clinical application of lazertinib, a third‐generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, has extended to the treatment of EGFR‐mutant non‐small‐cell lung cancer (NSCLC); however, the effects of its dose modification on its efficacy and safet...

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Main Authors: Mi‐Hyun Kim, Min Ki Lee, Ji Eun Park, Sun Hyo Park, Tae Won Jang, Chi Young Jung, Insu Kim, Seong Hoon Yoon, June Hong Ahn, Hyun‐Kyung Lee, Jin Han Park, Sun Ha Choi, Jung Seop Eom
Format: Article
Language:English
Published: Wiley 2025-05-01
Series:Thoracic Cancer
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Online Access:https://doi.org/10.1111/1759-7714.70083
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author Mi‐Hyun Kim
Min Ki Lee
Ji Eun Park
Sun Hyo Park
Tae Won Jang
Chi Young Jung
Insu Kim
Seong Hoon Yoon
June Hong Ahn
Hyun‐Kyung Lee
Jin Han Park
Sun Ha Choi
Jung Seop Eom
author_facet Mi‐Hyun Kim
Min Ki Lee
Ji Eun Park
Sun Hyo Park
Tae Won Jang
Chi Young Jung
Insu Kim
Seong Hoon Yoon
June Hong Ahn
Hyun‐Kyung Lee
Jin Han Park
Sun Ha Choi
Jung Seop Eom
author_sort Mi‐Hyun Kim
collection DOAJ
description ABSTRACT Introduction The clinical application of lazertinib, a third‐generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, has extended to the treatment of EGFR‐mutant non‐small‐cell lung cancer (NSCLC); however, the effects of its dose modification on its efficacy and safety have not yet been adequately established. Methods This prospective, multicenter, observational cohort study aims to evaluate the clinical implications of adjusting the lazertinib dose. Patients will be categorized into two groups based on the lazertinib dose administered during the initial 12 weeks of treatment in routine clinical practice: 160 and 240 mg groups. The primary endpoints are progression‐free survival in the 160 mg group and identifying risk factors associated with dose modification during the 12‐week period. Discussion The findings from the present study will provide real‐world insights into the clinical factors leading to lazertinib dose adjustments and deepen our understanding of the efficacy and safety of lazertinib in patients with NSCLC. Our research will contribute toward optimizing medical strategies for NSCLC treatment and aid clinicians in making accurate clinical decisions regarding dose modifications in routine practice.
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spelling doaj-art-006fc5625fe848f6b977158216189eaa2025-08-20T02:38:07ZengWileyThoracic Cancer1759-77061759-77142025-05-011610n/an/a10.1111/1759-7714.70083Impact of Modifying Lazertinib Doses on Effectiveness and Safety in Patients With EGFR‐Positive Advanced Lung Cancer: A Multicenter, Prospective Observational Cohort StudyMi‐Hyun Kim0Min Ki Lee1Ji Eun Park2Sun Hyo Park3Tae Won Jang4Chi Young Jung5Insu Kim6Seong Hoon Yoon7June Hong Ahn8Hyun‐Kyung Lee9Jin Han Park10Sun Ha Choi11Jung Seop Eom12Department of Internal Medicine Pusan National University School of Medicine Busan Republic of KoreaDepartment of Internal Medicine Pusan National University School of Medicine Busan Republic of KoreaDepartment of Internal Medicine, School of Medicine Kyungpook National University Daegu Republic of KoreaDivision of Pulmonology, Respiratory Center, Keimyung University Dongsan Hospital Keimyung University School of Medicine Daegu Republic of KoreaDepartment of Internal Medicine Kosin University Medical College Busan Republic of KoreaDepartment of Internal Medicine Catholic University of Daegu School of Medicine Daegu Republic of KoreaDepartment of Internal Medicine, College of Medicine Dong‐A University Busan Republic of KoreaDepartment of Internal Medicine Pusan National University Yangsan Hospital Yangsan Republic of KoreaDepartment of Internal Medicine, College of Medicine Yeungnam University Daegu Republic of KoreaDivision of Pulmonary, Allergy, and Critical Care Medicine, Department of Internal Medicine, Inje University Busan Paik Hospital Inje University College of Medicine Busan Republic of KoreaDivision of Pulmonology and Critical Care Medicine, Department of Internal Medicine, Haeundae Paik Hospital Inje University College of Medicine Busan Republic of KoreaDepartment of Internal Medicine, School of Medicine Kyungpook National University Chilgok Hospital Daegu Republic of KoreaDepartment of Internal Medicine Pusan National University School of Medicine Busan Republic of KoreaABSTRACT Introduction The clinical application of lazertinib, a third‐generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, has extended to the treatment of EGFR‐mutant non‐small‐cell lung cancer (NSCLC); however, the effects of its dose modification on its efficacy and safety have not yet been adequately established. Methods This prospective, multicenter, observational cohort study aims to evaluate the clinical implications of adjusting the lazertinib dose. Patients will be categorized into two groups based on the lazertinib dose administered during the initial 12 weeks of treatment in routine clinical practice: 160 and 240 mg groups. The primary endpoints are progression‐free survival in the 160 mg group and identifying risk factors associated with dose modification during the 12‐week period. Discussion The findings from the present study will provide real‐world insights into the clinical factors leading to lazertinib dose adjustments and deepen our understanding of the efficacy and safety of lazertinib in patients with NSCLC. Our research will contribute toward optimizing medical strategies for NSCLC treatment and aid clinicians in making accurate clinical decisions regarding dose modifications in routine practice.https://doi.org/10.1111/1759-7714.70083dose modificationepidermal growth factor receptorlazertinibtreatment outcome
spellingShingle Mi‐Hyun Kim
Min Ki Lee
Ji Eun Park
Sun Hyo Park
Tae Won Jang
Chi Young Jung
Insu Kim
Seong Hoon Yoon
June Hong Ahn
Hyun‐Kyung Lee
Jin Han Park
Sun Ha Choi
Jung Seop Eom
Impact of Modifying Lazertinib Doses on Effectiveness and Safety in Patients With EGFR‐Positive Advanced Lung Cancer: A Multicenter, Prospective Observational Cohort Study
Thoracic Cancer
dose modification
epidermal growth factor receptor
lazertinib
treatment outcome
title Impact of Modifying Lazertinib Doses on Effectiveness and Safety in Patients With EGFR‐Positive Advanced Lung Cancer: A Multicenter, Prospective Observational Cohort Study
title_full Impact of Modifying Lazertinib Doses on Effectiveness and Safety in Patients With EGFR‐Positive Advanced Lung Cancer: A Multicenter, Prospective Observational Cohort Study
title_fullStr Impact of Modifying Lazertinib Doses on Effectiveness and Safety in Patients With EGFR‐Positive Advanced Lung Cancer: A Multicenter, Prospective Observational Cohort Study
title_full_unstemmed Impact of Modifying Lazertinib Doses on Effectiveness and Safety in Patients With EGFR‐Positive Advanced Lung Cancer: A Multicenter, Prospective Observational Cohort Study
title_short Impact of Modifying Lazertinib Doses on Effectiveness and Safety in Patients With EGFR‐Positive Advanced Lung Cancer: A Multicenter, Prospective Observational Cohort Study
title_sort impact of modifying lazertinib doses on effectiveness and safety in patients with egfr positive advanced lung cancer a multicenter prospective observational cohort study
topic dose modification
epidermal growth factor receptor
lazertinib
treatment outcome
url https://doi.org/10.1111/1759-7714.70083
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