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A Phase 3, Open-label, Randomized Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Patients With EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy
Janssen Research & Development, LLC
This study is seeking to simplify the administration of amivantamab intravenous (IV) 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 has the potential to enhance both the patient and physician experience by providing easier and accelerated administration. Eligible participants will be randomly allocated to one of two Experimental Arms. In Experimental Arm A, participants will receive Lazertinib (240mg) will be administered orally once daily, plus Amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF) (1600mg / 2240mg depending on the body weight) administered by manual injection. In Experimental Arm B, participants will receive Lazertinib (240mg) administered once daily, plus Amivantamab (1050mg or 1400mg depending on the body weight) administered as an IV infusion.