TERMINATED

A Study of TAS3351 in NSCLC Patients With EGFRmt

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1/2 Study of TAS3351 in Patients With Advanced Non-Small Cell Lung Cancer and EGFR Mutations

Quick Facts

Study Start:2023-05-25
Study Completion:2025-03-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT05765734

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Locally advanced, non-resectable or metastatic NSCLC
  2. * Have adequate organ function
  3. * Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
  4. * Has tumor tissue available to allow for analysis of EGFRmt status
  5. * Has any sensitizing EGFRmt and a confirmed C797S EGFRmt
  6. * Has measurable disease per RECIST v1.1
  1. * Participating in medical research not compatible with this study
  2. * Symptomatic and unstable CNS metastases
  3. * Have not recovered from prior cancer treatment
  4. * Have a significant cardiac condition
  5. * Are a pregnant or breastfeeding female
  6. * A serious illness or medical condition
  7. * Unable to swallow or digest pills

Contacts and Locations

Study Locations (Sites)

Georgetown University - Lombardi Comprehensive Cancer Center
Washington, District of Columbia, 20007
United States
Tennessee Oncology
Nashville, Tennessee, 37203
United States
University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
United States
Next Oncology - Virginia
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Taiho Oncology, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-25
Study Completion Date2025-03-14

Study Record Updates

Study Start Date2023-05-25
Study Completion Date2025-03-14

Terms related to this study

Keywords Provided by Researchers

  • Non-Small Cell Lung Cancer
  • NSCLC
  • EGFR mutation
  • C797S mutation
  • TAS3351

Additional Relevant MeSH Terms

  • Non-Small Cell Lung Cancer