Study on Telaglenastat Hydrochloride and Osimertinib for Treating Stage IV Non-small Cell Lung Cancer with EGFR Mutation

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT03831932

This clinical trial is testing the safety and best dose of a new drug combination, telaglenastat hydrochloride and osimertinib, for patients with stage IV non-small cell lung cancer that has a specific EGFR gene mutation. These drugs may help stop cancer growth by blocking certain enzymes needed for tumor cells to grow.

Patient Parameters

Parameter	Options

Program Overview

The purpose of this study is to find out if the combination of telaglenastat hydrochloride and osimertinib is safe and to determine the best dose for treating patients with stage IV non-small cell lung cancer (NSCLC) that has a mutation in the EGFR gene. These drugs work by blocking enzymes that help cancer cells grow. The study will also look at how the drugs are processed in the body and their effects on the cancer's progression and overall survival.

Description

This study is divided into two phases. In the first phase, researchers will determine the safest dose of telaglenastat hydrochloride when combined with osimertinib. In the second phase, they will expand the study to more patients to further evaluate the treatment's effectiveness.

Participants will take telaglenastat hydrochloride twice a day and osimertinib once a day. Each treatment cycle lasts 28 days, and patients will continue treatment as long as it is effective and side effects are manageable. Throughout the study, participants will have regular blood tests and imaging scans to monitor their health and the cancer's response to treatment.

After completing the study treatment, patients will have a follow-up visit 30 days later to check their health status.

Eligibility Criteria

Inclusion Criteria

Have stage IV non-small cell lung cancer with an EGFR mutation confirmed by a tissue biopsy.
Experienced disease progression after previous EGFR inhibitor therapy.
Have at least one measurable tumor.
Be over 18 years old.
Be able to swallow pills.
Have a life expectancy of more than 3 months.
Meet specific blood count and organ function requirements.
If previously infected with hepatitis B or C, must meet specific criteria for control of the infection.
Have treated brain metastases with no signs of progression.
Be able to understand and sign a consent form.

Exclusion Criteria

Have not recovered from side effects of previous cancer treatments.
Have a history of lung diseases like interstitial lung disease or radiation pneumonitis.
Are currently taking other investigational drugs or have taken them recently.
Have uncontrolled illnesses or psychiatric conditions that could interfere with the study.
Have a history of severe allergic reactions to similar drugs.
Are pregnant or breastfeeding.
Have significant heart problems or risk factors for heart issues.
Have other active cancers or conditions that could interfere with the study.
Have difficulty absorbing oral medications.

Locations

FACILITY	ZIP	CITY	STATE
University of Alabama at Birmingham Cancer Center	35233	Birmingham	Alabama
UM Sylvester Comprehensive Cancer Center at Coral Gables	33146	Coral Gables	Florida
UM Sylvester Comprehensive Cancer Center at Deerfield Beach	33442	Deerfield Beach	Florida
University of Miami Miller School of Medicine-Sylvester Cancer Center	33136	Miami	Florida
UM Sylvester Comprehensive Cancer Center at Plantation	33324	Plantation	Florida
University of Kentucky/Markey Cancer Center	40536	Lexington	Kentucky
Case Western Reserve University	44106	Cleveland	Ohio
Ohio State University Comprehensive Cancer Center	43210	Columbus	Ohio
University of Pittsburgh Cancer Institute (UPCI)	15232	Pittsburgh	Pennsylvania
Huntsman Cancer Institute/University of Utah	84112	Salt Lake City	Utah

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