NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031220742

Registered date:24/04/2023

Phase 1/2 of TAS3351 in NSCLC patients with EGFRmt

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedPatients with Advanced Non-Small Cell Lung Cancer and EGFR Mutations
Date of first enrollment24/04/2023
Target sample size200
Countries of recruitmentUnited States,Japan,Germany,Japan,France,Japan
Study typeInterventional
Intervention(s)TAS3351 will be administered orally, continuous daily dosing, cycles lasting 21 days.

Outcome(s)

Primary Outcome- Safety - ORR per RECIST v1.1
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include 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 RECIST v1.1
Exclude criteria- Participating in medical research not compatible with this study - Symptomatic and unstable 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

Related Information

Contact

Public contact
Name Maho Ashikawa
Address 1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo Tokyo Japan 101-8444
Telephone +81-3-3293-2455
E-mail th-tas3351_info@taiho.co.jp
Affiliation Taiho Pharmaceutical Co., Ltd.
Scientific contact
Name Elizabeth Calleja
Address 1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo Tokyo Japan 101-8444
Telephone +81-3-3293-2455
E-mail th-tas3351_info@taiho.co.jp
Affiliation Taiho Pharmaceutical Co., Ltd.