A Study of TAS3351 in NSCLC Patients With EGFRmt

Last updated: March 13, 2026
Sponsor: Taiho Oncology, Inc.
Overall Status: Terminated

Phase

1

Condition

Non-small Cell Lung Cancer

Treatment

TAS3351

TAS3351 oral administration

Clinical Study ID

NCT05765734
10073010
2022-502595-23
2022-502595-23-00
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 18
Treatment Group(s): 2
Primary Treatment: TAS3351
Phase: 1
Study Start date:
May 25, 2023
Estimated Completion Date:
March 14, 2025

Study 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.

Connect with a study center

  • Institut Gustave Roussy

    Villejuif, Val De Marne 94805
    France

    Site Not Available

  • Universitaetsklinikum Koeln

    Cologne, North Rhine-Westphalia 50937
    Germany

    Site Not Available

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba 277-8577
    Japan

    Site Not Available

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka 411-8777
    Japan

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Democratic People's Republic of

    Site Not Available

  • Leiden University Medical Center (LUMC)

    Leiden, 2333ZA
    Netherlands

    Site Not Available

  • Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • University of Texas M. D. Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Next Oncology - Virginia

    Fairfax, Virginia 22031
    United States

    Site Not Available

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