NCT05765734

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Taiho Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	TAS3351	Oral tablets.

Timeline

• Start date: 2023-05-25
• Primary completion: 2025-03-14
• Completion: 2025-03-14
• First posted: 2023-03-13
• Last updated: 2026-04-02
• Results posted: 2026-04-02

Locations

8 sites across 5 countries: United States, France, Germany, Japan, Netherlands

Regulatory

• FDA-regulated drug study