Lung cancer is one of the most common types of cancer and is the most common cause of death from cancer. Amivantamab is a low-fucose, fully human immunoglobulin (IgG)1-based bispecific antibody directed against EGFR and mesenchymal-epithelial transition (MET) tyrosine kinase receptors. Lazertinib is an oral, highly potent, third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). The study will include screening phase (up to 28 days), a treatment phase (from randomization until the end of treatment visit), and a follow-up phase (from end of treatment visit until the end of study, death, lost to follow-up, or withdrawal of consent, whichever comes first). Safety will be assessed by physical examinations, vital signs, electrocardiograms, echocardiograms, ophthalmologic assessments, laboratory tests, adverse event (AE) frequency and severity (by Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) monitoring, and concomitant medication use. The total duration of the study will be up to 1 year and 11 months.
The purpose of the study is to simplify amivantamab intravenous administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), for subcutaneous administration. This formulation has the potential to enhance both the patient and physician experience with amivantamab by providing easier and accelerated administration.