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TerminatedPhase 1NCT05765734
Official study title

A Study of TAS3351 in NSCLC Patients With EGFRmt

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedTAS3351

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · EGFR · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 2, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?8 U.S. locations

Locations may change over time.

Who runs it?Taiho Oncology, Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Taiho Oncology, Inc.
Interventions being studied
Drug: TAS3351
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→
Biomarkers
EGFR→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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)
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Tennessee OncologyNashville, Tennessee
  • University of Texas M. D. Anderson Cancer CenterHouston, Texas
  • Next Oncology - VirginiaFairfax, Virginia
  • Institut Gustave RoussyVillejuif, Val De Marne
  • Universitaetsklinikum KoelnCologne, North Rhine-Westphalia
  • National Cancer Center Hospital EastKashiwa-shi, Chiba
  • Shizuoka Cancer CenterSunto-gun, Shizuoka
  • Leiden University Medical Center (LUMC)Leiden

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 2, 2026. Always confirm current availability with the study team.

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