A Study of TAS3351 in NSCLC Patients With EGFRmt

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.

Conditions

Non-Small Cell Lung Cancer

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Study Overview

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Study Details

Study overview

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.

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

A Study of TAS3351 in NSCLC Patients With EGFRmt

Condition
Non-Small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Washington

Georgetown University - Lombardi Comprehensive Cancer Center, Washington, District of Columbia, United States, 20007

Nashville

Tennessee Oncology, Nashville, Tennessee, United States, 37203

Houston

University of Texas M. D. Anderson Cancer Center, Houston, Texas, United States, 77030

Fairfax

Next Oncology - Virginia, Fairfax, Virginia, United States, 22031

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * Has any sensitizing EGFRmt and a confirmed C797S EGFRmt
  • * Has measurable disease per RECIST v1.1
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Taiho Oncology, Inc.,

Study Record Dates

2027-12