Lung cancer is one of the most common types of cancer and is the most common cause of death from cancer. NSCLC accounts for 80 percent (%) to 85% of lung cancers with epidermal growth factor receptor (EGFR) mutations, the Exon 19 deletion (Exon19del) and Exon 21 leucine 858 to arginine substitution (Exon 21 L858R) point mutations. Amivantamab is a low-fucose, fully human immunoglobulin (IgG)1-based bispecific antibody directed against EGFR and mesenchymal-epithelial transition (MET) tyrosine kinase receptors. The rationale for this study is to collect efficacy, safety, and PK data to support the use of amivantamab SC-CF in regimens and populations currently under study and approved with the IV formulation of amivantamab. The study will include a screening phase (28 days), a treatment phase (21 days [Cohorts 2 and 3] or 28 days [Cohort 1, 4, 5 and 6]), and a follow up phase (after last study treatment until disease progression or death, whichever comes first). Safety assessments will include physical examinations, vital signs, electrocardiograms (ECGs), echocardiograms, ophthalmologic assessments (All cohorts except cohort 4 and in Cohort 4 [where applicable]), laboratory tests, adverse event (AE) frequency and severity (by Common Terminology Criteria for Adverse Events [CTCAE] v5.0) monitoring, and concomitant medication use (all cohorts). The total duration of the study is up to 1 year 6 months.
The purpose of this study is to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation [SC-CF]) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4).