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A Randomized Study to Evaluate the Efficacy of a Reduced Starting Dose of Lazertinib (Leclaza) and Preemtive Magnesium Supplementation to Prevent Lazertinib(Leclaza)-Induced Peripheral Neuropathy
Sponsor: Samsung Medical Center
Summary
Lazertinib is currently approved as a first-line treatment for EGFR-mutant NSCLC in South Korea. However, many patients experience peripheral neuropathy, which causes severe numbness, tingling, or painful muscle cramps. This side effect significantly lowers patients' quality of life and often leads to treatment interruptions. This phase 2, open-label, randomized clinical trial newly diagnosed EGFR mutant NSCLC patients is based on the hypothesis that a lower dose of lazertinib combined with magnesium supplementation will result in a more tolerable safety profile without compromising efficacy outcomes
Official title: A Randomized Study to Evaluate the Efficacy of a Reduced Starting Dose of Lazertinib (Leclaza) and Preemptive Magnesium Supplementation to Prevent Lazertinib (Leclaza)-Induced Peripheral Neuropathy
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1173
Start Date
2026-05-26
Completion Date
2029-12-31
Last Updated
2026-08-19
Healthy Volunteers
No
Interventions
Supplementation of magnesium lactate
Supplementation of magnesium lactate
Dose reduction of lezertinib
Dose reduction of lazertinib 240mg to 160mg qd
Locations (1)
Samsung Medical Center
Seoul, Gang-nam Gu, South Korea