A Study of TAS3351 in NSCLC Patients With EGFRmt
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.
Checked against the public recordLast updated Apr 2, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Taiho Oncology, Inc.
- Interventions being studied
- Drug: TAS3351
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
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.