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.
Additional locations may be listed on ClinicalTrials.gov for NCT05765734.
See trial information on ClinicalTrials.gov for a list of participating sites.
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
