A Study of TAS3351 in NSCLC Patients With EGFRmt

Stopped early · Phase 1

Conditions studied: Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT05765734

Run by

Taiho Oncology, Inc.

People needed

18

Starts

2023-05-25

Expected to finish

2025-03-14

Last updated by the study team

2026-04-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Tennessee Oncology — Nashville, Tennessee, United States
• University of Texas M. D. Anderson Cancer Center — Houston, Texas, United States
• Next Oncology - Virginia — Fairfax, Virginia, United States
• Institut Gustave Roussy — Villejuif, Val De Marne, France
• Universitaetsklinikum Koeln — Cologne, North Rhine-Westphalia, Germany
• National Cancer Center Hospital East — Kashiwa-shi, Chiba, Japan
• Shizuoka Cancer Center — Sunto-gun, Shizuoka, Japan
• Leiden University Medical Center (LUMC) — Leiden, Netherlands

Full record on ClinicalTrials.gov

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