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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT04780568
Phase
PHASE1
Status
Recruiting
Apply to this trial

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib — DRUG
    Given PO
  • Tegavivint — DRUG
    Given IV
  • Echocardiography Test — PROCEDURE
    Undergo ECHO
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA scan
  • Computed Tomography — PROCEDURE
    Undergo CT
  • FDG-Positron Emission Tomography — PROCEDURE
    Undergo 18F-FDG PET
  • Biospecimen Collection — PROCEDURE
    Undergo blood and/or tissue sample collection

Study Details

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.

Key Dates

Start date
Jan 18, 2022
Status verified
Dec 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2029

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (osimertinib, tegavivint)
    Patients receive osimertinib PO QD on days 1-28 and tegavivint IV on day 1. Treatment repeats 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. Treatment repeats every 28 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum tolerated dose [ Time Frame: Up to 28 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Regan M. Memmott, M.D., Ph.D
[email protected]
614-366-1618
Regan M. Memmott, M.D., Ph.D (PRINCIPAL_INVESTIGATOR)

Find similar trials in Columbus, OH

By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

Related Studies