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 • ClinicalTrials.gov ID: NCT07774520
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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
Interventions
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Supplementation of magnesium lactate
(Drug)
Supplementation of magnesium lactate
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Dose reduction of lezertinib
(Drug)
Dose reduction of lazertinib 240mg to 160mg qd
Eligibility criteria
Conditions
Locations
- Samsung Medical Center — Seoul, Gang-nam Gu, South Korea
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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