A Study of TAS3351 in Patients with Advanced NSCLC and EGFR Mutations
Research type
Research Study
Full title
A Phase 1/2 Study of TAS3351 in Patients with Advanced Non-Small Cell Lung Cancer and EGFR Mutations
IRAS ID
1007755
Contact name
Yogesh Patel
Contact email
Sponsor organisation
Taiho Oncology Inc.
Clinicaltrials.gov Identifier
Research summary
This study examines the effects of a not approved drug TAS3351 in patients with Non-Small Cell Lung Cancer (NSCLC) that has spread through the body. NSCLC with EGFR mutations (changes in genes, the instruction books of our cells, responsible to signal to grow/divide/produce) can cause a loop production of cells. We know different types of EGFR mutations (EGFR mt). Current treatments block most common types, can stop working and the tumour may learn to resist, which makes treatment options limited and the survival rate is low. TAS3351 also blocks some of the most common types of EGFR mt and a newer one called C797S found in patients who no longer respond to approved EGFR mt blockers.
The purpose of the study is to see how safe TAS3351 is, find a recommended dose, and see how well it works against NSCLC with EGFR mt and particularly the C797S mutation.
The study is enrolling roughly 200 patients in multiple countries and consists of three parts:Dose Escalation
Part A1
for up to 40 patients, first-in-patient administration and dose finding. The UK will not enroll patients in part A1 of the study.
Part A2
for up to 20 patients, information gathering how safe the study drug is at the dose identified in Part A1 and its potential effects on tumour growth.
Dose Expansion Part B
for up to 40 patients, Assessment of recommended dose from Part A, looking at safety and effectiveness in larger patient number
Phase 2 Part C
for approximately 100 patients, assesses safety and how effective the drug is in an even more patients.
All parts will have a Screening, treatment and Follow up, as outlined in the PIS
The response/ effectiveness of the drug will be confirmed by imaging; safety will be monitored.
Parts A2, B, and C require that patients have the C797S mutation, hence a prescreening consent may be signed to confirm the mutation in an archived tumour sample or a fresh blood sample.
Patients will receive TAS3351 until they meet discontinuation criteria.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
23/YH/0275
Date of REC Opinion
15 Jan 2024
REC opinion
Further Information Unfavourable Opinion