NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT07774520

RecruitingPhase 2

Sponsor: Samsung Medical Center

Conditions: Non-small Cell Lung Cancer(NSCLC), EGFR Mutant

Interventions: Supplementation of magnesium lactate, Dose reduction of lezertinib

Countries: South Korea

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

Eligibility overview

Sex: ALL

Age: 19 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Seoul, Gang-nam Gu, South Korea