Supplementation of magnesium lactate / Non Small Cell Lung Cancer(nsclc) / Dose reduction of lezertinib · Phase 2 Trial

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

ClinicalTrials.gov · August 19, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 2 clinical trial registry record for an ongoing, recruiting study evaluating whether reduced-dose lazertinib plus magnesium supplementation can prevent lazertinib-induced peripheral neuropathy in EGFR-mutant NSCLC without compromising efficacy. No results are currently available in this registry entry, and the study remains actively enrolling.

What was studied

Phase 2, Interventional, Randomized, Parallel, Open label, Prevention purpose. Non-small Cell Lung Cancer(NSCLC), EGFR Mutant; age from 19 Years. Intervention: Arm 3. Compared with: Arm 2 — Active Comparator; Arm 1 — No Intervention. n = 1,173. 1 site: South Korea.

Key findings

Safety

No efficacy or safety results reported in this registry record; study is still recruiting. No baseline characteristics, adverse event data, or outcome analyses are available at this stage.

Who this may help

This study is hypothesis-generating and designed to inform dose optimization and toxicity mitigation strategies for lazertinib in EGFR-mutant NSCLC. Results are not yet available and should be awaited before any clinical implementation.

Plain-language summary

This is a Phase 2 registry record with no reported results; the study is actively recruiting and designed to test a hypothesis about dose reduction and supplementation to prevent a known toxicity.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Difference of grade 2 or higher peripheral neuropathy (assessed at From date of randomization until the date of first documented progression or da…)

DesignPhase 2, Interventional, Randomized, Parallel, Open label, Prevention purpose

PopulationNon-small Cell Lung Cancer(NSCLC), EGFR Mutant; age from 19 Years

Sample size1,173

InterventionArm 3

ComparatorArm 2 — Active Comparator; Arm 1 — No Intervention

Setting1 site: South Korea

Reported figures

Quoted from the source exactly as published.

Planned enrollment1173

PhasePHASE 2

Primary outcome measureDifference of grade 2 or higher peripheral neuropathy from date of randomization until date of first documented progression or date of death from any cause, or onset of peripheral neuropathy assessed up to 36 months

Study typeINTERVENTIONAL

Recruitment statusRECRUITING

Clinical bottom line

Caveats

No efficacy or safety results reported in this registry record; study is still recruiting.
Open-label design limits ability to assess unbiased efficacy outcomes.
Study registered in South Korea; generalizability to other populations unclear.
No baseline characteristics, adverse event data, or outcome analyses are available at this stage.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 2, open-label, randomized, but open-label design limits blinding.

Directness

strong

Primary outcome directly measures grade 2+ peripheral neuropathy incidence.

Consistency

insufficient

Registry record contains no results; consistency cannot be assessed.

Risk of bias

limited

Open-label design introduces bias; no blinding of participants or assessors.

Sample adequacy

moderate

Estimated enrollment 1173 participants; adequate for Phase 2 hypothesis testing.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07774520). This is a study registration, not published results. Lead sponsor: Samsung Medical Center. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 1173 participants (ESTIMATED). Conditions: Non-small Cell Lung Cancer(NSCLC), EGFR Mutant. Interventions: DRUG: Supplementation of magnesium lactate; DRUG: Dose reduction of lezertinib. Primary outcome measures: Difference of grade 2 or higher peripheral neuropathy , From date of randomization until the date of first documented progression or date of death from any cause, or onset of peripheral neuropathy assessed up to 36 months. Brief 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

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Samsung Medical CenterSupplementation of magnesium lactateNCT07774520Non Small Cell Lung Cancer(nsclc)Dose reduction of lezertinibEGFR Mutant