Non-small Cell Lung Cancer(NSCLC)Phase 2NCT07774520
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
A Phase 2 study testing Supplementation of magnesium lactate and Dose reduction of lezertinib in people with Non-small Cell Lung Cancer(NSCLC) and EGFR Mutant, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer(NSCLC), EGFR Mutant
- What is being tested?
- Supplementation of magnesium lactate and Dose reduction of lezertinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,173 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 May 2026to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patient able to decide on participation in this study through voluntary decision-making.
- Age 19 years or more.
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- ECOG PS 0-2.
- Minimum life expectancy 12 weeks or more.
- Adequate organ function.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Gang-nam Gu, 06351
Jong-Mu Sun, 82-2-3410-3459, jongmu.sun@samsung.com
About this study
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
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
Read the detailed description
Although lazertinib has been successfully established as a standard first-line targeted therapy for EGFR-mutant non-small cell lung cancer (NSCLC) in South Korea, its long-term clinical utility is frequently challenged by treatment limiting toxicities. Chief among these is peripheral neuropathy, which manifests as severe numbness, tingling sensations, or painful muscle cramps in the hands and feet. This distressing side effect not only profoundly impairs patients' daily functioning and overall quality of life but also frequently necessitates unplanned dose reductions or treatment interruptions, potentially compromising long-term oncological outcomes.
To address this clinical unmet need, this phase 2, open-label, randomized clinical trial will evaluate 177 newly diagnosed patients to investigate optimization strategies aimed at mitigating nerve toxicity. The study is designed around the hypothesis that initiating treatment with a lower starting dose of lazertinib (160 mg/day) and introducing preemptive magnesium supplementation will significantly reduce the incidence of moderate-to-severe (Grade 2 or higher) peripheral neuropathy. Ultimately, the researchers aim to demonstrate that this novel intervention strategy can establish a highly tolerable safety profile, thereby preventing treatment interruptions and enhancing patient compliance, all while successfully maintaining the robust therapeutic efficacy of the core cancer treatment.
- Conditions
- Non-small Cell Lung Cancer(NSCLC), EGFR Mutant
- Being tested
- Supplementation of magnesium lactate, Dose reduction of lezertinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplementation of magnesium lactateDrug
Supplementation of magnesium lactate
Dose reduction of lezertinibDrug
Dose reduction of lazertinib 240mg to 160mg qd
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | No intervention | Lazertinib 240mg without magnesium supplement |
| Arm 2 | Active comparator | Lazertinib 240mg with magnesium lactate supplement Receives: Drug: Supplementation of magnesium lactate |
| Arm 3 | Experimental | Reduced dose of Lazertinib(160mg) with magnesium supplement Receives: Drug: Supplementation of magnesium lactate; Drug: Dose reduction of lezertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 (5)
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
Improvement of lazertinib reduction or supplement of magnesium in peripheral neuropathy
In Arm 1 (lazertinib 240 mg/day without magnesium supplement) or Arm 2 (lazertinib 240 mg/day with magnesium supplement), the rate at which peripheral neuropathy improves to grade 1 or grade 0 following lazertinib dose reduction (160 mg/day) and/or additional magnesium use, when grade 2 or higher peripheral neuropathy develops during the study
Measured: From development of peripheral neuropathy up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start26 May 2026
- Primary completion1 Jun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer(NSCLC)Studies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,173 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong-Mu Sun, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774520
- Sponsor's protocol ID
- SMC 2026-06-08
- Status last verified
- Aug 2026
- First submitted
- 17 Jun 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The only clinical outcome data will be published
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07774520
- Acronym / sponsor ID
- SMC 2026-06-08
- Conditions
- Non-small Cell Lung Cancer(NSCLC), EGFR Mutant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,173 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 26 May 2026 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Although lazertinib has been successfully established as a standard first-line targeted therapy for EGFR-mutant non-small cell lung cancer (NSCLC) in South Korea, its long-term clinical utility is frequently challenged by treatment limiting toxicities. Chief among these is peripheral neuropathy, which manifests as severe numbness, tingling sensations, or painful muscle cramps in the hands and feet. This distressing side effect not only profoundly impairs patients' daily functioning and overall quality of life but also frequently necessitates unplanned dose reductions or treatment interruptions, potentially compromising long-term oncological outcomes.
To address this clinical unmet need, this phase 2, open-label, randomized clinical trial will evaluate 177 newly diagnosed patients to investigate optimization strategies aimed at mitigating nerve toxicity. The study is designed around the hypothesis that initiating treatment with a lower starting dose of lazertinib (160 mg/day) and introducing preemptive magnesium supplementation will significantly reduce the incidence of moderate-to-severe (Grade 2 or higher) peripheral neuropathy. Ultimately, the researchers aim to demonstrate that this novel intervention strategy can establish a highly tolerable safety profile, thereby preventing treatment interruptions and enhancing patient compliance, all while successfully maintaining the robust therapeutic efficacy of the core cancer treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | No intervention | –Lazertinib 240mg without magnesium supplement |
| Arm 2 | Active comparator | Drug: Supplementation of magnesium lactateLazertinib 240mg with magnesium lactate supplement |
| Arm 3 | Experimental | Drug: Supplementation of magnesium lactate, Drug: Dose reduction of lezertinibReduced dose of Lazertinib(160mg) with magnesium supplement |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Patient able to decide on participation in this study through voluntary decision-making.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supplementation of magnesium lactateSupplementation of magnesium lactate | Drug | Arm 2, Arm 3 |
| Dose reduction of lezertinibDose reduction of lazertinib 240mg to 160mg qd | Drug | Arm 3 |
Primary outcome
Difference of grade 2 or higher peripheral neuropathy
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
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).
5 secondary outcomes
Difference in grade 2 or higher peripheral neuropathy between two experimental arm 2 and 3
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
Objective response rate between different lazertinib starting 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
Progression free survival between different lazertinib starting 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
Overall survival between different lazertinib starting 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
Improvement of lazertinib reduction or supplement of magnesium in peripheral neuropathy
Time frame: From development of peripheral neuropathy up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No. The only clinical outcome data will be published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Supplementation of magnesium lactate and Dose reduction of lezertinib in people with Non-small Cell Lung Cancer(NSCLC) and EGFR Mutant, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonmu Sun Sun, MD,PhD (82-2-3410-3459, jongmu.sun@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of grade 2 or higher peripheral neuropathy (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026; AzTrials last refreshed its copy on 30 Oct 2026.