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A Phase 3, Randomized Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib Versus Lazertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer.
Janssen-Cilag Pty Ltd
Eligible patients will be randomised into Arm A, Arm B or Arm C of the trial, receiving different combinations of treatment depending on which Arm they are assigned. Patients in Arm A will receive intravenous Amivantamab at a dose adjusted to their body weight, once weekly in Cycle 1 and then every 2 weeks in subsequent cycles. These patients (in Arm A) will also receive an oral dose of Lazertinib (240mg) once daily. Patients in Arm B will receive an oral dose of Osimertinib (80mg), plus a Lazertinib-matching placebo (240mg) once daily. Patients in Arm C will receive oral Lazertinib (240mg), plus an Osimertinib-matching placebo (80mg) once daily.