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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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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
Trial Details
NCT Number NCT07774520
Lead Sponsor Samsung Medical Center
Conditions
(from sponsor)		 Non-small Cell Lung Cancer(NSCLC), EGFR Mutant
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 1,173 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov