Lower starting lazertinib dose with magnesium to prevent nerve side effects in EGFR-mutant NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2, open-label, randomized trial compares a reduced starting dose of lazertinib (160 mg/day) with preemptive magnesium supplementation versus standard considerations to see if it lowers the risk of moderate-to-severe peripheral neuropathy while maintaining cancer control. The study plans to enroll 177 eligible, newly diagnosed patients with EGFR-mutant NSCLC who require first-line therapy. Primary aims are safety and tolerability, with secondary goals including treatment efficacy and continuation without dose interruptions. The approach addresses a common treatment-limiting toxicity to improve quality of life and adherence.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Pathologically diagnosed pulmonary adenocarcinoma.
2. Patient with a stage not amenable to curative treatment by surgery or radiotherapy and requiring palliative chemotherapy.
3. Patient with no prior treatment history for lung cancer, or who relapsed \>=6 months after curative-intent therapy (concurrent chemoradiotherapy or adjuvant chemotherapy) with no subsequent anticancer treatment - i.e., a candidate for first-line chemotherapy.
4. Patient with a confirmed EGFR mutation of Exon 19 deletion or L858R.
5. Patient able to decide on participation in this study through voluntary decision-making.
6. Age 19 years or more.
7. ECOG PS 0-2.
8. Minimum life expectancy 12 weeks or more.
9. Adequate organ function.

Exclusion Criteria:

* Subjects with confirmed leptomeningeal/CNS metastasis on brain MRI or cerebrospinal fluid examination.
* Subjects with pre-existing peripheral neuropathy.
* Subjects who are taking any agent that may affect the development of peripheral neuropathy for reasons other than peripheral neuropathy (magnesium, pregabalin, gabapentin, duloxetine) and refuse to discontinue its use.
* Subjects for whom, in the physician's judgment, participation in this study would carry greater harm than benefit (no specific items specified).
* Uncontrolled systemic disease, including uncontrolled hypertension, severe heart failure, active bleeding, or active infection.
* Pregnant or breastfeeding women.
* History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid treatment, or evidence of clinically active ILD.
* QTc prolongation based on QTc measured by ECG during the screening period (QTc \>=470 msec).
* Subjects with a history of hypersensitivity to Magnes tablet.
* Subjects with hereditary disorders of sugar metabolism such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
* Subjects with a history of severe symptomatic renal failure.
* Subjects taking a drug expected to have a clinically significant interaction when co-administered with magnesium-containing preparations - such as phosphate preparations, calcium preparations, oral tetracyclines, antacids, or levodopa - for whom discontinuation or substitution of the drug is not possible.

Where it's running

• Samsung Medical Center
  Seoul, Gang-nam Gu, South Korea Recruiting

Study contacts

• Study coordinator: Jonmu Sun Sun, MD,PhD
• Email: jongmu.sun@samsung.com
• Phone: 82-2-3410-3459

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.