Impact of Lazertinib Dose Modification on Effectiveness and Safety

Sponsor
Pusan National University Hospital
Study ID
NCT05716672
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lazertinib — DRUG
    Lazertinib 240mg(3tablets, 80mg/1tablet), once a day(QD), oral(PO), until disease progression or unacceptable toxicity

Study Details

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

Key Dates

Start date
Feb 1, 2023
Status verified
Jan 2023
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: 240mg group
    Maintenance of the 240mg dose for 12 weeks after the first administration of Lazertinib
  • Arm: 160mg group
    Reduction of the 160mg dose for 12 weeks after the first administration of Lazertinib

Primary Outcome Measure

Progression Free Survival(PFS) [ Time Frame: Up to approximately 3 years ]

Central Contacts

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