Telaglenastat Hydrochloride and Osimertinib in Treating Patients With EGFR-Mutated Stage IV Non-small Cell Lung Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03831932
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Advanced Lung Non-Small Cell Carcinoma
  • Metastatic Lung Non-Small Cell Carcinoma
  • Stage IV Lung Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Magnetic Resonance Elastography — PROCEDURE
    Undergo MRI
  • Osimertinib — DRUG
    Given PO
  • Positron Emission Tomography — PROCEDURE
    Undergo PET scan
  • Telaglenastat Hydrochloride — DRUG
    Given PO
  • X-Ray Imaging — PROCEDURE
    Undergo x-ray imaging

Study Details

This phase Ib trial studies the side effects and best dose of telaglenastat hydrochloride when given together with osimertinib in treating patients with stage IV non-small cell lung cancer and a mutation in the EGFR gene. Telaglenastat hydrochloride and osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date
Mar 16, 2020
Status verified
Mar 2026
Primary completion
Jun 12, 2024
Completion
Mar 13, 2027

Study Design

Enrollment
22 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (telaglenastat HCl, osimertinib)
    Patients receive telaglenastat hydrochloride PO BID and osimertinib PO QD (starting cycle 1 day 16 of phase I). Patients undergo blood sample collection and may undergo x-ray imaging, CT scan, MRI, or PET scan throughout the study. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Recommended Phase II Dose (RP2D) [ Time Frame: Up to 28 days ]

Locations (11)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham Cancer CenterBirminghamAlabama35233-
UM Sylvester Comprehensive Cancer Center at Coral GablesCoral GablesFlorida33146-
UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield BeachFlorida33442-
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiamiFlorida33136-
UM Sylvester Comprehensive Cancer Center at PlantationPlantationFlorida33324-
University of Kentucky/Markey Cancer CenterLexingtonKentucky40536-
Case Western Reserve UniversityClevelandOhio44106-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112-
University of Virginia Cancer CenterCharlottesvilleVirginia22908-

Related coverage on Hipa.ai

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham Cancer Center· Birmingham, ALUM Sylvester Comprehensive Cancer Center at Coral Gables· Coral Gables, FLUM Sylvester Comprehensive Cancer Center at Deerfield Beach· Deerfield Beach, FLUniversity of Miami Miller School of Medicine-Sylvester Cancer Center· Miami, FLUM Sylvester Comprehensive Cancer Center at Plantation· Plantation, FLUniversity of Kentucky/Markey Cancer Center· Lexington, KY

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