Sponsor: Janssen
Sponsor Study ID: 61186372NSC3004
Study Title: A Phase 3, Open label, Randomized Study of Lazertinib with Subcutaneous Amivantamab Administered via Manual Injection Compared with Intravenous Amivantamab or Amivantamab Subcutaneous On Body Delivery System in Patients with EGFR mutated Advanced or Metastatic Non small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy
CTO #: 103633
NCT Number: NCT05388669
Phase: III
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Lung
Study Objectives: The primary objective is to assess the pharmacokinetic noninferiority of amivantamab SC-CF via manual injection versus amivantamab IV. Key secondary objectives are to assess efficacy (objective response rate [ORR] and progression-free survival [PFS]) and safety of the different administrations