Is Lazcluze approved for treating Non-Small Cell Lung Cancer with specific EGFR mutations?

Lazcluze (lazertinib) is a targeted therapy for non-small cell lung cancer (NSCLC) that has specific mutations in the epidermal growth factor receptor (EGFR) gene. It is not used alone; it is approved by the U.S. Food and Drug Administration (FDA) for use in combination with another drug called amivantamab. This combination is for adults with NSCLC that has spread locally or to other parts of the body and whose tumors have certain EGFR mutations: exon 19 deletions or exon 21 L858R substitution mutations ². These are common EGFR mutations that make the cancer sensitive to targeted therapies.

What the research says

The FDA approval of Lazcluze (lazertinib) with amivantamab is based on clinical trials showing benefit in patients with EGFR-mutant NSCLC. One phase 1 trial (CHRYSALIS cohort E) tested the combination in patients whose cancer had progressed on a prior third-generation EGFR TKI (like osimertinib) but who had not yet received chemotherapy. In that exploratory cohort of 45 patients, the overall response rate (tumor shrinkage) was 36%, with a median duration of response of 9.6 months and median progression-free survival of 4.9 months ⁹. This suggests the combination can work even after resistance to other EGFR inhibitors. Another source notes that amivantamab plus lazertinib is recommended as a first-line treatment for advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations ¹⁰. Additionally, a 2025 review of FDA-approved kinase inhibitors lists lazertinib as approved for NSCLC ¹¹. The approval is specifically for first-line use in combination with amivantamab, as stated in the FDA labeling ². Common side effects of the amivantamab-lazertinib regimen include skin reactions (rash, nail changes, itching), swelling (peripheral edema), low albumin levels, and infusion-related reactions ¹⁰.

What to ask your doctor

• Do I have the specific EGFR mutations (exon 19 deletion or exon 21 L858R) that make Lazcluze a treatment option?
• Is the combination of Lazcluze and amivantamab appropriate for my stage of NSCLC and as a first-line treatment?
• What are the common side effects of this combination, and how can they be managed?
• Are there any other targeted therapies or clinical trials I should consider based on my mutation profile?
• How does this treatment compare with other options like osimertinib or chemotherapy for my situation?