Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-27 @ 12:28 PM
Study NCT ID:
NCT04780568
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2021-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osimertinib and Tegavivint as First-Line Therapy for the Treatment of Metastatic EGFR-Mutant Non-small Cell Lung Cancer
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2021-01360 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |