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Tyrosine Kinase Inhibitor
Telaglenastat + Osimertinib for Non-Small Cell Lung Cancer
Phase 1 & 2
Recruiting
Led By Dwight H Owen
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) by chest x-ray or as >= 10 mm (>= 1 cm) with computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 15 of cycle 1, day 2 of cycle 2 and day 1 of each subsequent cycle (each cycle = 28 days)
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of a new drug, telaglenastat hydrochloride, when given with osimertinib to treat patients with stage IV non-small cell lung cancer that has a mutation in the EGFR gene.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Potential side effects include typical reactions from targeted cancer therapies such as fatigue, digestive issues, skin reactions, possible liver enzyme changes, and risks associated with long QT syndrome which affects heart rhythm.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a tumor that can be measured and is big enough according to specific guidelines.
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My heart function is classified as class 2B or better, despite my history of heart issues or treatments.
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My cancer progressed despite previous treatments with EGFR inhibitors.
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I am older than 18 years.
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My EGFR gene has a specific mutation, confirmed by a recent tissue biopsy.
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My cancer progressed after first-line EGFR inhibitor therapy with osimertinib.
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I can take care of myself but might not be able to do heavy physical work.
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My lung cancer is at stage IV and has spread to other areas.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 15 of cycle 1, day 2 of cycle 2 and day 1 of each subsequent cycle (each cycle = 28 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 15 of cycle 1, day 2 of cycle 2 and day 1 of each subsequent cycle (each cycle = 28 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended phase II dose (RP2D)
Secondary outcome measures
Dose limiting toxicities (DLT)
Overall survival (OS)
Progression-free survival (PFS)
Other outcome measures
Change in 18F-fluorodeoxyglucose (18F-FDG)-positron emission tomography (PET) imaging
Change in EGFR mutational status
Change in circulating levels of glutamine, glutamate, aspartate, and asparagine
+2 moreTrial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1700
Computed Tomography
2017
Completed Phase 2
~2720
Positron Emission Tomography
2008
Completed Phase 2
~2240
Osimertinib
2017
Completed Phase 4
~1010
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,664 Previous Clinical Trials
40,926,105 Total Patients Enrolled
Dwight H OwenPrincipal InvestigatorOhio State University Comprehensive Cancer Center LAO
2 Previous Clinical Trials
86 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have NSCLC and no other active cancers, except for certain low-risk or localized types.You are expected to live for more than 3 months.My brain scans show no worsening after treatment for brain metastases.I can understand and am willing to sign the consent form, or I have someone who can do it for me.Your hemoglobin level is at least 90 grams per liter.I have not had a major heart event like a heart attack in the last 6 months.I have a tumor that can be measured and is big enough according to specific guidelines.I have hepatitis B but no hepatitis C or HIV.My heart function is classified as class 2B or better, despite my history of heart issues or treatments.I have recovered from previous cancer treatment side effects, except for hair loss or conditions not worsened by new treatment.I have a history of lung conditions needing steroid treatment.I don't have active brain issues from cancer, or if I do, they've been stable for 2 weeks.My cancer progressed despite previous treatments with EGFR inhibitors.I am not pregnant or breastfeeding.Your white blood cell count is equal to or greater than 3,000 per microliter.I have another cancer type, but it won't affect this trial's treatment.My heart's electrical activity and function are normal.I am not taking, or can stop taking, strong CYP3A4 inducers before starting the study treatment.I am older than 18 years.I have brain metastases causing symptoms and affecting my stability.My EGFR gene has a specific mutation, confirmed by a recent tissue biopsy.You cannot have taken any other experimental drugs for a certain period of time, and if you have had immunotherapy before, it must have been at least 3 months ago.My kidney function, measured by creatinine or GFR, is within the required range.My cancer progressed after first-line EGFR inhibitor therapy with osimertinib.Your liver enzymes (AST and ALT) are not too high.I am not allergic to telaglenastat, osimertinib, or similar medications.I can take care of myself but might not be able to do heavy physical work.I have issues that could affect my ability to absorb pills, like severe nausea or a major gut surgery.My lung cancer is at stage IV and has spread to other areas.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (telaglenastat HCl, osimertinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can you tell me about any other scientific studies that have used Osimertinib?
"There are presently 111 clinical studies underway for Osimertinib. Of these, 17 have reached Phase 3 testing. The majority of investigational sites for this treatment are located in Uniondale, New york; however, there are 4789 total research centres running trials for Osimertinib globally."
Answered by AI
Are there different sites where this experiment is taking place throughout Canada?
"Patients are currently being enrolled at the Ohio State University Comprehensive Cancer Center, located in Columbus, Ohio. In addition, the University of Miami Miller School of Medicine-Sylvester Cancer Center in Miami, Virginia is participating as well as Case Western Reserve University in Cleveland, Alabama. There are also 11 other locations that are not listed where this study is taking place."
Answered by AI
How many individuals are participating in this clinical trial?
"Yes, the trial is active and posted on clinicaltrials.gov. It was created on 5/2/2019 and edited on 10/4/2022. They are looking for 18 individuals across 11 sites."
Answered by AI
Are there any vacancies in this study for potential participants?
"That is correct. Information available on clinicaltrials.gov shows that this research project, which was established on May 2nd 2019, is presently seeking patients. The study requires 18 individuals in total, with 11 different centres hosting the trial."
Answered by AI
What unique benefits does this trial offer compared to others like it?
"Osimertinib is being studied in 111 active clinical trials located across 51 countries and 1063 cities. The first trial began in 2013 and, after completing Phase 1 & 2 testing, was approved for public use. In the intervening 8 years, 40 more studies have been completed."
Answered by AI
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