This is a first-in-human, open label, Phase 1/2 study to investigate the safety and
efficacy of TAS3351 in patients with advanced or metastatic non-small cell lung cancer
(NSCLC) harboring an acquired C797S epidermal growth factor receptor (EGFR) mutation.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05765734.
This study will be conducted in 3 parts (i.e. dose escalation, dose expansion, and a
phase 2 portion). The dose escalation part will investigate the safety and determine the
recommended phase 2 dose and the recommended dosing regimen of TAS3351 administered
orally. The dose expansion part will explore the efficacy of TAS3351 in NSCLC patients
with C797S EGFR mutations. The phase 2 part will assess the efficacy of TAS3351 in NSCLC
patients with C797S EGFR mutations.
Lead OrganizationTaiho Pharmaceutical Company Limited
