Spots Global Cancer Trial Database for A Study of TAS3351 in NSCLC Patients With EGFRmt
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Trial Identification
Brief Title: A Study of TAS3351 in NSCLC Patients With EGFRmt
Official Title: A Phase 1/2 Study of TAS3351 in Patients With Advanced Non-Small Cell Lung Cancer and EGFR Mutations
Study ID: NCT05765734
Conditions
Interventions
Study Description
Brief Summary: This is a first-in-human, open label, Phase 1/2 study to investigate the safety and efficacy of TAS3351 in patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring an acquired C797S epidermal growth factor receptor (EGFR) mutation.
Detailed 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 patients with C797S EGFR mutations. The phase 2 part will assess the efficacy of TAS3351 in NSCLC patients with C797S EGFR mutations.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Georgetown University - Lombardi Comprehensive Cancer Center, Washington, District of Columbia, United States
Tennessee Oncology, Nashville, Tennessee, United States
University of Texas M. D. Anderson Cancer Center, Houston, Texas, United States
Next Oncology - Virginia, Fairfax, Virginia, United States
Institut Gustave Roussy, Villejuif cedex, Val De Marne, France
Universitaetsklinikum Koeln, Koeln, Nordrhein Westfalen, Germany
IEO Istituto Europeo di Oncologia, Milano, , Italy
National Cancer Center Hospital East, Kashiwa-shi, Chiba-Ken, Japan
Shizuoka Cancer Center, Sunto-gun, Shizuoka-Ken, Japan
Cancer Institute Hospital of JFCR, Koto-Ku, , Japan
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seul, , Korea, Republic of
Antoni van Leeuwenhoek, Amsterdam, , Netherlands
Leiden University Medical Center (LUMC), Leiden, , Netherlands
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
The Christie Hospital, Manchester, Greater Manchester, United Kingdom
Contact Details
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