RecruitingPhase 1NCT04780568

Osimertinib and Tegavivint as First-Line Therapy for the Treatment of Metastatic EGFR-Mutant Non-small Cell Lung Cancer

A Phase Ib Study of AZD9291 (Osimertinib) and BC2059 (Tegavivint) as First-Line Therapy in Patients With Metastatic EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC)


Sponsor

Ohio State University Comprehensive Cancer Center

Enrollment

24 participants

Start Date

Jan 18, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This phase Ib trial is to find out the best dose, possible benefits and/or side effects of osimertinib and tegavivint as first-line therapy in treating patients with EGFR-mutant non-small cell lung cancer that has spread to other places in the body (metastatic). Osimertinib and tegavivint may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two drugs — osimertinib (a targeted therapy for EGFR-mutant lung cancer) and tegavivint (a drug that blocks a cancer cell survival pathway called Wnt/beta-catenin) — as a first-line treatment for people with metastatic non-small cell lung cancer carrying an EGFR mutation. Adding tegavivint may help delay resistance to osimertinib. **You may be eligible if...** - You are 18 or older with confirmed metastatic non-small cell lung cancer (NSCLC) - Your tumor has a common EGFR mutation (exon 19 deletion or L858R) confirmed by tumor biopsy - You have not yet received any treatment for metastatic NSCLC - Your organ function (blood, liver, kidneys) is adequate **You may NOT be eligible if...** - You do not have an EGFR mutation confirmed by tumor tissue testing - You have previously received osimertinib or another EGFR-targeted drug - You have untreated or unstable brain metastases - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGOsimertinib

Given PO

DRUGTegavivint

Given IV

PROCEDUREEchocardiography Test

Undergo ECHO

PROCEDUREMultigated Acquisition Scan

Undergo MUGA scan

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREFDG-Positron Emission Tomography

Undergo 18F-FDG PET

PROCEDUREBiospecimen Collection

Undergo blood and/or tissue sample collection


Locations(1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04780568


Related Trials