Telaglenastat + Osimertinib for Non-Small Cell Lung Cancer
What You Need to Know Before You Apply
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.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but you should avoid medications or supplements that strongly affect CYP3A4 enzymes. It's best to discuss your current medications with the trial team to ensure they don't interfere with the study.
Is the combination of Telaglenastat and Osimertinib safe for humans?
Osimertinib, used for treating certain types of lung cancer, has been associated with common side effects like diarrhea, rash, dry skin, and nail issues. Serious side effects occurred in about 28% of patients, with some stopping treatment due to these effects. While this data is specific to Osimertinib, it provides insight into potential safety concerns.12345
What makes the drug combination of Telaglenastat and Osimertinib unique for non-small cell lung cancer?
This drug combination is unique because Osimertinib is a third-generation drug specifically designed to target a common resistance mutation (EGFR T790M) in non-small cell lung cancer, while Telaglenastat may enhance its effectiveness by targeting cancer cell metabolism, offering a novel approach to overcoming resistance.26789
What data supports the effectiveness of the drug combination Telaglenastat and Osimertinib for treating non-small cell lung cancer?
Who Is on the Research Team?
Dwight Owen, MD
Principal Investigator
Ohio State University Comprehensive Cancer Center LAO
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive telaglenastat hydrochloride PO BID and osimertinib PO QD starting cycle 1 day 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension
Participants may continue treatment in the absence of disease progression or unacceptable toxicity
What Are the Treatments Tested in This Trial?
Interventions
- Osimertinib
- Telaglenastat Hydrochloride
Osimertinib is already approved in United States, European Union for the following indications:
- Locally advanced or metastatic non-small-cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R mutations
- Metastatic EGFR T790M mutation-positive NSCLC
- Locally advanced or metastatic non-small-cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R mutations
- Metastatic EGFR T790M mutation-positive NSCLC
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor