Telaglenastat + Osimertinib for Non-Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

+10 other locations

Overseen byDwight Owen, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Dwight Owen, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center LAO

Eligibility Criteria

Adults over 18 with stage IV non-small cell lung cancer and specific EGFR gene mutations, who have had disease progression after prior EGFR inhibitor therapy. They must be able to swallow pills, have a life expectancy over 3 months, and meet certain blood count and organ function criteria. Excluded are those with significant cardiovascular history, other active malignancies at high risk of relapse, uncontrolled illnesses or infections like HIV.

Inclusion Criteria

You have enough white blood cells called neutrophils.

Your platelet count is at least 100,000 per microliter.

Your total bilirubin level needs to be within a certain range, unless you have Gilbert's disease. If you have Gilbert's disease, your bilirubin level can be slightly higher.

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Exclusion Criteria

Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol, or active infection with human immunodeficiency virus (HIV). Screening for chronic conditions is not required

Patients with psychiatric illness/social situations that would limit compliance with study requirements

I have NSCLC and no other active cancers, except for certain low-risk or localized types.

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Treatment Details

Interventions

Osimertinib (Tyrosine Kinase Inhibitor)
Telaglenastat Hydrochloride (Enzyme Inhibitor)

Trial OverviewThe trial is testing the combination of Telaglenastat Hydrochloride and Osimertinib for safety and optimal dosage in patients with advanced lung cancer harboring EGFR mutations. It aims to see if these drugs can block enzymes necessary for tumor growth.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (telaglenastat HCl, osimertinib)Experimental Treatment7 Interventions

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.