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RECRUITING
NCT07774520
PHASE2

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

View on ClinicalTrials.gov

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

DRUG

Supplementation of magnesium lactate

Supplementation of magnesium lactate

DRUG

Dose reduction of lezertinib

Dose reduction of lazertinib 240mg to 160mg qd

Locations (1)

Samsung Medical Center

Seoul, Gang-nam Gu, South Korea