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NCT05716672
Impact of Lazertinib Dose Modification on Effectiveness and Safety
Conditions: Non-small Cell Lung Cancer
Sex: All
Ages: 20 Years – N/A
Enrollment: 200
Sponsor: Pusan National University Hospital
Location: Korea, Republic of
Summary
The primary objective is to evaluate Progression Free Survival (PFS) of the group (160 mg group) in which dose reduction was performed for 12 weeks after the first administration of Lazertinib.The Secondary objectives of this study are as follows.To evaluate Progression-free survival (PFS) of the group maintaining the same dose (240mg group) and the group in which dose reduction was performed (160mg group) for 12 weeks after the first administration of LazertinibIn the group maintaining the same dose (240mg group) and the group in which dose reduction was performed (160mg group) for 12 weeks after the first administration of Lazertinib, Time-to-Treatment Discontinuation(TTD), Objective Response Rate(ORR), Disease Control Rate(DCR), Tumor shrinkage and Overall Survival(OS) is evaluated.In the group maintaining the same dose (240mg group) and the group in which dose reduction was performed (160mg group) for 12 weeks after the first administration of Lazertinib, specific reasons (adverse event name, grade, etc.) according to Lazertinib dose adjustment is evaluated.To evaluate the treatment profile of Lazertinib including duration of treatment, dose adjustment, and reason for discontinuation of treatment.To evaluate the safety of Lazertinib in the 240 mg and 160 mg groups
Eligibility Criteria
Inclusion Criteria:Patients who agreed in writing to participate in this studyAdult men and women over 20 years of agePatients with locally advanced or metastatic, recurrent non-small cell lung cancer with EGFR mutation (based on AJCC 8th edition)Patients with confirmed disease progression after 1st or 2nd generation EGFR-TKI treatmentPatients scheduled to receive Lazertinib after T790M mutation was confirmed positive in tissue or plasmaExclusion Criteria:Patients who are receiving or have already completed LazertinibPatients whose life expectancy is less than 12 weeks
Source: ClinicalTrials.gov (NCT05716672). StuddyBuddy aggregates publicly available trial information.