Telaglenastat + Osimertinib for Non-Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the optimal dose and understand the side effects of combining telaglenastat hydrochloride with osimertinib, a targeted therapy drug, for treating stage IV non-small cell lung cancer, particularly in patients with a specific EGFR gene mutation. These drugs block certain enzymes that fuel tumor growth. This trial may suit those with stage IV non-small cell lung cancer who have previously taken EGFR inhibitor therapy and experienced disease progression. Participants should be able to swallow pills and have a life expectancy of more than three months. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this combination therapy.
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 there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that telaglenastat hydrochloride, when combined with other treatments, is generally well tolerated by patients. A previous study found no unexpected safety issues, although effectiveness varied among different groups. Osimertinib, already approved for treating advanced non-small cell lung cancer (NSCLC) with specific mutations, demonstrated a strong response in similar patients and was considered safe without any surprises.
These drugs work together to stop cancer cells from growing by blocking certain enzymes the cells need. While both treatments have been studied individually, this trial explores their combined effectiveness and aims to determine the best dose.12345Why do researchers think this study treatment might be promising?
Researchers are excited about telaglenastat combined with osimertinib for non-small cell lung cancer because it offers a unique approach to treatment. Unlike standard therapies that often target specific mutations, telaglenastat inhibits glutaminase, an enzyme that cancer cells rely on for growth. This combination aims to starve the cancer cells of the nutrients they need to survive. Meanwhile, osimertinib is an established treatment targeting EGFR mutations, making this combo a promising strategy to tackle cancer from multiple angles. This dual-action approach could potentially improve outcomes for patients with this type of lung cancer.
What evidence suggests that telaglenastat hydrochloride and osimertinib could be effective for non-small cell lung cancer?
Research has shown that osimertinib effectively treats non-small cell lung cancer with specific changes in the EGFR gene. It outperforms earlier treatments by extending the time patients live without cancer progression and by increasing overall survival. In this trial, researchers are studying the combination of telaglenastat hydrochloride and osimertinib to determine if it can further enhance these outcomes. This combination might work by blocking enzymes necessary for cancer cell growth, potentially preventing tumor progression. Early study results suggest this combination could be a promising treatment option for patients with this type of lung cancer.678910
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