Spots Global Cancer Trial Database for Impact of Lazertinib Dose Modification on Effectiveness and Safety
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Trial Identification
Brief Title: Impact of Lazertinib Dose Modification on Effectiveness and Safety
Official Title: Impact of Lazertinib Dose Modification on Effectiveness and Safety in EGFR T790M-Positive Advanced Lung Cancer
Study ID: NCT05716672
Conditions
Interventions
Study Description
Brief 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. 1. 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 Lazertinib 2. 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, Time-to-Treatment Discontinuation(TTD), Objective Response Rate(ORR), Disease Control Rate(DCR), Tumor shrinkage and Overall Survival(OS) is evaluated. 3. 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. 4. To evaluate the treatment profile of Lazertinib including duration of treatment, dose adjustment, and reason for discontinuation of treatment. 5. To evaluate the safety of Lazertinib in the 240 mg and 160 mg groups
Detailed Description: This study is a prospective multi-center observational study, and 11 institutions will participate to enroll 200 subjects competitively. We will evaluate the efficacy and safety of Lazertinib according to maintenance of the 240mg dose and reduction of the 160mg dose for 12 weeks after the first administration of Lazertinib in non-small cell lung cancer patients confirmed to be T790M mutation-positive after treatment failure with first- or second-generation EGFR-TKIs. The study period is up to 3 years from the date of IRB approval. Follow-up is 2 years from the last subject enrollment, and data will be collected through periodic medical record review during Lazertinib administration for enrolled subjects.
Keywords
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Inje University Busan Paik Hospital, Busan, , Korea, Republic of
Inje University Haeundae Paik Hospital, Busan, , Korea, Republic of
Dong-A University Hospital, Busan, , Korea, Republic of
Pusan National University Hospital, Busan, , Korea, Republic of
Kosin University Gospel Hospital, Busan, , Korea, Republic of
Kyungpook National University Chilgok Hospital, Daegu, , Korea, Republic of
Kyungpook National University Hospital, Daegu, , Korea, Republic of
Yeungnam University Medical Center, Daegu, , Korea, Republic of
Daegu Catholic University Medical Center, Daegu, , Korea, Republic of
Keimyung University Dongsan Medical Center, Daegu, , Korea, Republic of
Pusan National University Yangsan Hospital, Yangsan, , Korea, Republic of
Contact Details
Name: Min Ki Lee, MD, PhD
Affiliation: Pusan National University Hospital
Role: PRINCIPAL_INVESTIGATOR
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