None listed
Conditions
Interventions
Drug : This is an open-label, randomized clinical study.
1) After obtaining informed consent from patients who meet the eligibility criteria,
2) subjects will be assigned to one of three treatment gr
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Pathologically confirmed pulmonary adenocarcinoma (2) Patients with disease not amenable to curative treatment by surgery or radiotherapy who require palliative systemic chemotherapy (3) Patients who are treatment-naïve for lung cancer, or who experienced recurrence at least 6 months after completion of curative-intent therapy (e.g., concurrent chemoradiotherapy or adjuvant chemotherapy) without receiving any subsequent systemic anticancer treatment, and are therefore eligible for first-line systemic therapy (4) Patients confirmed to harbor EGFR mutations of either Exon 19 deletion or L858R (5) Patients capable of voluntarily deciding to participate in this study (6) Age =19 years (7) ECOG Performance Status 0–2 (8) Life expectancy of at least 12 weeks (9) Adequate organ function (10) Female subjects must be either non-childbearing potential or agree to use appropriate contraception during the study period.
Exclusion criteria
Exclusion criteria: (1) Patients with leptomeningeal metastasis confirmed by brain MRI or cerebrospinal fluid (CSF) examination (2) Patients with pre-existing peripheral neuropathy (3) Patients currently taking medications that may affect the development of peripheral neuropathy for reasons other than peripheral neuropathy itself (including magnesium, pregabalin, gabapentin, or duloxetine) who refuse discontinuation of such medications (4)Patients with uncontrolled systemic diseases, including uncontrolled hypertension, severe heart failure, active bleeding, or active infection (5) Pregnant or breastfeeding women (6) Patients with interstitial lung disease (ILD), drug-induced ILD, a history of radiation pneumonitis requiring steroid treatment, or evidence of clinically active ILD (7) Patients with QTc prolongation (QTc =470 msec) based on ECG performed during the screening period (8) Patients with a history of hypersensitivity to the active ingredients or excipients of Lazcluze® (lazertinib) or Magnes® tablets (9) Patients with hereditary disorders of carbohydrate metabolism, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption (10) Patients with a history of severe symptomatic renal impairment (11) Patients receiving medications expected to have clinically significant interactions with magnesium-containing products, including phosphate preparations, calcium salts, oral tetracycline agents, antacids, or levodopa, for whom discontinuation or substitution of such medications is not feasible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR): During the study treatment period, tumor response will be evaluated every 12 weeks using chest CT or equivalent radiologic imaging modalities. The objective response rate will be calculated according to the RECIST criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS): Progression-free survival is defined as the time from randomization to documented disease progression or death from any cause.;Overall Survival (OS): Overall survival is defined as the time from randomization to death from any cause.;Peripheral Neuropathy Toxicity Assessment: Evaluated using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). | — |
Countries
Korea, Republic of
Contacts
Public ContactJong-Mu Sun
Samsung Medical Center
Outcome results
None listed