Actively Recruiting
Osimertinib and Tegavivint as First-Line Therapy for the Treatment of Metastatic EGFR-Mutant Non-small Cell Lung Cancer
Led by Ohio State University Comprehensive Cancer Center · Updated on 2025-12-09
24
Participants Needed
1
Research Sites
393 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase Ib trial is to find out the best dose, possible benefits and/or side effects of osimertinib and tegavivint as first-line therapy in treating patients with EGFR-mutant non-small cell lung cancer that has spread to other places in the body (metastatic). Osimertinib and tegavivint may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
CONDITIONS
Official Title
Osimertinib and Tegavivint as First-Line Therapy for the Treatment of Metastatic EGFR-Mutant Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Metastatic non-small cell lung cancer confirmed by pathology
- Presence of a common activating EGFR mutation (exon 19 deletion or L858R), or uncommon mutations co-occurring with a common mutation
- Mutation status verified by tumor biopsy from a CLIA-certified lab
- Measurable disease by RECIST 1.1 criteria
- ECOG performance status 0, 1, or 2 (Karnofsky score >= 60%)
- Ability to swallow pills
- Life expectancy greater than 3 months
- Leukocytes count >= 3,000/mcL
- Absolute neutrophil count >= 1,500/mcL
- Platelet count >= 100,000/mcL
- Hemoglobin >= 90 g/L
- Total bilirubin <= 1.5 times institutional upper limit normal (ULN), up to 3 mg/dL for Gilbert's syndrome
- AST and ALT <= 2.5 times ULN, or <= 5 times ULN if liver metastases present
- Creatinine within 1.5 times ULN or glomerular filtration rate >= 50 mL/min/1.73 m2
- Controlled chronic hepatitis B or C infection with undetectable viral load if applicable
- Patients with treated asymptomatic brain metastases or stable active brain metastases not requiring immediate CNS treatment
- Patients with prior or concurrent malignancies that do not interfere with study assessments
- Cardiac function classified as New York Heart Association class 2B or better
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior treatment with any EGFR tyrosine kinase inhibitor
- Unresolved side effects from prior anti-cancer therapy above grade 1 (except alopecia)
- History of interstitial lung disease or radiation pneumonitis requiring steroids
- Participation in other investigational or immunotherapy treatments within five half-lives or 3 months
- Uncontrolled intercurrent illness
- Psychiatric or social situations limiting study compliance
- Allergic reactions to osimertinib, tegavivint, or their excipients
- Use of medications or supplements that strongly induce CYP3A4 and cannot be stopped
- Pregnant or breastfeeding women
- Significant cardiovascular disease or recent myocardial infarction or thrombotic events
- Cardiac abnormalities including prolonged QT interval or reduced left ventricular ejection fraction
- Active malignancies other than NSCLC or high-risk prior malignancies except certain skin or indolent cancers
- Severe or uncontrolled systemic diseases including active HIV infection
- Conditions impairing oral drug absorption
- Investigator judgment that patient is unlikely to comply with study requirements
- Involvement in planning or conduct of this study by patient or site staff
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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