Clinical trial · Interventional
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
NCT05765734CI-TRIAL-00107138TAS3351terminatedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor's decision, not based on safety concerns
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TAS3351 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (9)
- type
- EXPERIMENTAL
- label
- Part A1: Dose Escalation: 50 mg
- description
- Participants received TAS3351 50 milligrams (mg), tablets, orally, once daily (QD), on Days 1-21 of each 21-day cycle, for maximum duration of 66 days.
- interventionNames
- Drug: TAS3351
- type
- EXPERIMENTAL
- label
- Part A1: Dose Escalation: 100 mg
- description
- Participants received TAS3351 100 mg, tablets, orally, QD, on Days 1-21 of each 21-day cycle, for a maximum duration of 126 days.
- interventionNames
- Drug: TAS3351
- type
- EXPERIMENTAL
- label
- Part A1: Dose Escalation: 200 mg
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.