LBA6 Befotertinib (D-0316) versus icotinib as first-line therapy for patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer: A multicentre, open-label, randomized phase III study

Abstract

Befotertinib (D-0316), a novel highly selective oral third-generation EGFR-TKI, exhibited encouraging antitumor activity in a pivotal phase II study (NCT03861156) in EGFR T790M mutation-positive patients (pts). This phase III, open-label, randomized trial was conducted to compare the efficacy and safety of befotertinib versus icotinib as first-line treatment in pts with previously untreated, locally advanced or metastatic NSCLC with EGFR-sensitizing mutation (Del19 or L858R).