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Osimertinib and Tegavivint as First-Line Therapy for the Treatment of Metastatic EGFR-Mutant Non-small Cell Lung Cancer

StatusRecruiting
PhasePhase 1
Started2022-01-18
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jul 31, 2026 → Dec 31, 2026
See other at-risk trials from Ohio State University Comprehensive Cancer Center

Amendment history

2026-09-16
Enrollment reopened
2026-08-10
Study Status, Study Design, Contacts/Locations v5
Enrollment closed, study ongoing
Primary completion pushed: 2026-07-31 → 2026-12-31
Study sitesdetails revised at 1 of 1 site
2025-12-02
Study Identification, Study Status, Oversight, Study Description, Conditions, Arms and Interventions, Outcome Measures, Contacts/Locations v4
Primary completion date2025-07-31→2026-07-31
InterventionsOsimertinib (Drug), Tegavivint (Drug)→Biospecimen Collection (Procedure), Computed Tomography (Procedure), Echocardiography Test (Procedure), FDG-Positron Emission Tomography…
Study description+338 characters
[...] eceive osimertinib orally (PO) once daily (QD) on days 1-28 of each cycle and tegavivint intravenously (IV) over 4 hours on daydays 1, 8, 15, and 22 of each cycle. TreatmentCycles repeatsrepeat every 28 days for 4 cycles in the absence of disease progre [...] xicity. Patients then receive osimertinib PO QD on days 1-28 of each cycle. TreatmentCycles repeatsrepeat every 28 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo echocardiography (ECHO) or multigated acquisition (MUGA) scan, CT, fludeoxyglucose F 18 (18F-FDG) positron emission tomography ( [...] [...]
Study sitescontacts updated at 1 of 1 site
Study titlerevised
Osimertinib and Tegavivint Asas First-Line Therapy for the Treatment of Metastatic EGFR-Mutant Non-small Cell Lung Cancer
2024-12-31
Study Identification, Study Status, Oversight, Conditions, Study Design, Contacts/Locations v3
Primary completion date2024-12-31→2025-07-31
Completion date2024-12-31→2029-07-31
Enrollment target18→24
Study sitescontacts updated at 1 of 1 site
Study titlerevised
Osimertinib and Tegavivint asAs First-Line Therapy for the Treatment of Metastatic EGFR-Mutant Non-small Cell Lung Cancer
2023-12-07
Study Status v2
Primary completion date2023-12-31→2024-12-31
2022-07-14
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations, IPDSharing, References v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-04-01→confirmed 2022-01-18
Study sitesdetails revised at 1 of 1 site
2021-02-28
Original filing
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.
Trial Details
NCT Number NCT04780568
Lead Sponsor Ohio State University Comprehensive Cancer Center
Conditions Metastatic Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8
Enrollment 25 participants
Start Date 2022-01-18
Primary Completion 2026-12-31 (estimated)
Study Completion 2029-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-15