Amivantamab is a bispecific epidermal growth factor receptor (EGF) receptor-directed and mesenchymal epithelial transition (MET) receptor-directed antibody with immune cell directing activity, which has received accelerated approval for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, after progression on or after platinum-based chemotherapy. Amivantamab given IV can cause IRRs. Lazertinib is a third-generation EGFR tyrosine kinase inhibitor (TKI) approved in the Republic of Korea for the treatment of patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC who have progressed on or after EGFR TKI therapy. The study consists of a screening period (up to 25 days), prophylaxis administration period (5 days), a treatment Phase (from cycle 1 Day 1 until the end of treatment visit) and end of study (up to 30 days after last dose). The safety of the study treatments (dexamethasone, montelukast, and methotrexate) and of the background anti-cancer therapy (intravenous [IV] amivantamab and lazertinib) will be assessed by physical examinations, clinical laboratory tests, vital signs, monitoring of adverse events (AEs), and concomitant medication usage. The total duration of the study is up to 14 months.
The purpose of the study is to separately assess the potential of dexamethasone, montelukast and methotrexate, administration, prior to amivantamab infusion given through a needle in the vein, to decrease the incidence and/or severity of infusion related reaction (IRR), when amivantamab is given in combination with Lazertinib (by mouth), to reduce first-dose IRRs.