Clinical Trial

A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination with Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination with Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (COPERNICUS) (61186372NSC2012)

MOA: Subcutaneous amivantamab is a bispecific ab against EGF and cMET receptors, that is co-formulated with rHuPH20. Lazertinib is a 3rd generation EGFR TKI.

Key Eligibility Criteria:

• Histologically or cytologically confirmed LA or metastatic NSCLC
• EGFR mutation must be an Ex19del or Ex21 L858R substitution (local). Liquid or tissue biopsy acceptable
• At least 1 measurable lesion, according to RECIST v1.1, not irradiated
• Cohort 1: No prior systemic therapy for adv/met NSCLC or any targeted tx for early disease stage
• 1 cycle of plt chemo is permitted prior to the first dose of treatment while awaiting liquid or tissue biopsy results
• Asymptomatic or previously treated and stable brain metastases are eligible