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RecruitingNCT04780568

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

A Phase Ib Study of AZD9291 (Osimertinib) and BC2059 (Tegavivint) as First-Line Therapy in Patients With Metastatic EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC)

Status
Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
24 (estimated)
Sponsor
Ohio State University Comprehensive Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. Assess the safety and tolerability of osimertinib (AZD9291) in combination with tegavivint (BC2059) in patients with metastatic EGFR-mutant non-small lung cancer (NSCLC) and determine the recommended phase 2 dose (RP2D). SECONDARY OBJECTIVES: I. Determine the objective response rate (ORR) in patients with metastatic EGFR-mutant NSCLC treated with the combination of AZD9291 and BC2059. II. Determine the progression free survival (PFS) in patients with metastatic EGFR-mutant NSCLC treated with the combination of AZD9291 and BC2059. III. Determine the duration of response (DOR) in patients with metastatic EGFR-mutant NSCLC treated with the combination of AZD9291 and BC2059. IV. Determine the overall survival (OS) in patients with metastatic EGFR-mutant NSCLC treated with the combination of AZD9291 and BC2059. CORRELATIVE/EXPLORATORY OBJECTIVES: I. Evaluate biomarkers of EGFR, Notch3, and beta-catenin pathway activity in tumor biopsies and blood samples. II. Assess the pharmacokinetics (PK) of AZD9291 and BC2059 in patients with metastatic EGFR-mutant NSCLC. III. Assess circulating tumor deoxyribonucleic acid (DNA) (ctDNA) at baseline, following 2 and 4 weeks of treatment to evaluate for clearance, and at time of progression to assess for changes in EGFR mutation status. IV. Measure response using computed tomography (CT) tumor volumetry and dynamic positron emission tomography (PET)/CT. V. Identify a gene signature that may be predictive of treatment response or resistance using ribonucleic acid (RNA) sequencing of tumor tissue. OUTLINE: Patients receive osimertinib orally (PO) once daily (QD) on days 1-28 of each cycle and tegavivint intravenously (IV) over 4 hours on days 1, 8, 15, and 22 of each cycle. Cycles repeat every 28 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive osimertinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days 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 (PET), and blood sample collection throughout the trial. Patients may also undergo tissue sample collection on study. After completion of study treatment, patients are followed up for 30 or 90 days and then every 12 weeks for 4 years.

Conditions

Interventions

TypeNameDescription
DRUGOsimertinibGiven PO
DRUGTegavivintGiven IV
PROCEDUREEchocardiography TestUndergo ECHO
PROCEDUREMultigated Acquisition ScanUndergo MUGA scan
PROCEDUREComputed TomographyUndergo CT
PROCEDUREFDG-Positron Emission TomographyUndergo 18F-FDG PET
PROCEDUREBiospecimen CollectionUndergo blood and/or tissue sample collection

Timeline

Start date
2022-01-18
Primary completion
2026-07-31
Completion
2029-07-31
First posted
2021-03-03
Last updated
2025-12-09

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04780568. Inclusion in this directory is not an endorsement.