P15.03 A Phase 1/1b Study of Lazertinib as Monotherapy and in Combination with Amivantamab in Advanced EGFR-Mutated NSCLC

Lazertinib: First Approval

“…An ongoing, open-label, multicentre study dose-escalation and dose-expansion phase 1/1b study (NCT04077463) is evaluating the safety, tolerability and pharmacokinetics of lazertinib as monotherapy (phase 1 dose escalation) and in combination with the EGFR-MET bispecific antibody amivantamab (phase 1b dose escalation and expansion parts A, B and C) in Japanese patients with advanced EGFR-mutated NSCLC [ 13 ]. The study has enrolled 11 patients in the phase 1 dose-escalation cohort and three patients in the phase 1b combination therapy cohort.…”

“…In the dose-escalation phase, no dose limiting toxicity was reported and the recommended phase 2 dose of lazertinib was confirmed as 240 mg once daily. Patients are currently being enrolled in the 1b dose-expansion cohort A to further characterize the safety, tolerability, and preliminary antitumor activity of lazertinib 240 mg once daily and amivantamab 1050 mg (1400 mg for patients ≥ 80 kg) intravenously once weekly for the first 28-day cycle and biweekly thereafter [ 13 ].…”