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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

ConditionsNon-small Cell Lung Cancer(NSCLC)EGFR Mutant
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorSamsung Medical Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Pathologically diagnosed pulmonary adenocarcinoma.

Patient with a stage not amenable to curative treatment by surgery or radiotherapy and requiring palliative chemotherapy.

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.

Patient with a confirmed EGFR mutation of Exon 19 deletion or L858R.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Supplementation of magnesium lactate

    Drug

    Supplementation of magnesium lactate

  • Dose reduction of lezertinib

    Drug

    Dose reduction of lazertinib 240mg to 160mg qd

Treatment groups

1,173 Participants
are divided into 3 treatment groups
Group A: Arm 1No intervention 0 interventions
Group B: Arm 2Active comparator 1 intervention
Group C: Arm 3Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Difference of grade 2 or higher peripheral neuropathy

To compare the incidence of grade 2 or higher peripheral neuropathy between the standard treatment arm (Arm 1: lazertinib 240 mg/day without magnesium supplementation) and the experimental arm (Arm 3: reduced-dose lazertinib 160 mg/day with magnesium supplementation).

Time frame
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

Secondary outcomes

1

Difference in grade 2 or higher peripheral neuropathy between two experimental arm 2 and 3

The difference in the incidence of grade 2 or higher peripheral neuropathy between the two experimental arms (Arms 2 and 3, Arm 2 is patient with lazertinib 240mg with magnesium supplement, and Arm 3 is patient with lazertinib 160mg with magnesium supplement), To evaluate the effect of magnesium supplement in different lazertinib dose

Time frame
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
2

Objective response rate between different lazertinib starting dose

The difference in objective response rate between the two different lazertinib starting-dose groups, Arm 1 and 2 which are treated with lazertinib 240mg, and Arm 3 with reduced dose of lazertinib 160mg

Time frame
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
3

Progression free survival between different lazertinib starting dose

The difference in progression free survival between the two different lazertinib starting-dose groups, Arm 1 and 2 which are treated with lazertinib 240mg, and Arm 3 with reduced dose of lazertinib 160mgTime

Time frame
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
4

Overall survival between different lazertinib starting dose

The difference in overall survival between the two different lazertinib starting-dose groups, Arm 1 and 2 which are treated with lazertinib 240mg, and Arm 3 with reduced dose of lazertinib 160mg

Time frame
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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Samsung Medical Center

Lead sponsor

Source ClinicalTrials.gov
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