A Study of TAS3351 in NSCLC Patients With EGFRmt

A Phase 1/2 Study of TAS3351 in Patients With Advanced Non-Small Cell Lung Cancer and EGFR Mutations

This is a first-in-human, open label, Phase 1/2 study to investigate the safety and efficacy of TAS3351 in participants with advanced or metastatic non-small cell lung cancer (NSCLC) harboring an acquired C797S epidermal growth factor receptor (EGFR) mutation.

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 participants with C797S EGFR mutations. The phase 2 part will assess the efficacy of TAS3351 in NSCLC participants with C797S EGFR mutations.

Inclusion Criteria:

• Locally advanced, non-resectable or metastatic NSCLC
• Have adequate organ function
• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
• Has tumor tissue available to allow for analysis of EGFRmt status

Dose Escalation:

• Has any EGFRmt status

Dose Escalation back-fill part, Dose Expansion and Phase II:

• Has any sensitizing EGFRmt and a confirmed C797S EGFRmt
• Has measurable disease per response evaluation criteria in solid tumors, version 1.1 (RECIST v1.1)

Exclusion Criteria:

• Participating in medical research not compatible with this study
• Symptomatic and unstable central nervous system (CNS) metastases
• Have not recovered from prior cancer treatment
• Have a significant cardiac condition
• Are a pregnant or breastfeeding female
• A serious illness or medical condition
• Unable to swallow or digest pills