RecruitingPhase 2NCT06014827

Biologically Guided Radiation Therapy (BgRT) and Stereotactic Body Radiation Therapy (SBRT) to Tyrosine Kinase Inhibitor in Oligoprogressive Oncogenic Positive Non-Small Cell Lung Carcinoma

Phase II Trial of the Addition of Biologically Guided Radiation Therapy (BgRT) and Stereotactic Body Radiation Therapy (SBRT) to Tyrosine Kinase Inhibitor in Oligoprogressive Oncogenic Positive Non-Small Cell Lung Carcinoma


Sponsor

City of Hope Medical Center

Enrollment

32 participants

Start Date

Oct 9, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests how well biologically guided radiation therapy (BgRT) and stereotactic body radiation therapy (SBRT) with osimertinib works for the treatment of EGFR positive non-small cell lung carcinoma that has spread from where it first started (primary site) to a limited number of anatomic sites (oligoprogressive). BgRT is radiation that uses specialized imaging to during treatment to target the active tumor and direct radiation to tumors in order to kill and shrink tumor cells. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Osimertinib is in a class of medications called kinase inhibitors. It works by blocking the action of a protein called EGFR that signals cancer cells to multiply. This helps slow or stop the spread of tumor cells. Giving BgRT with SBRT and osimertinib may kill more tumor cells in patients with oligoprogressive EGFR positive non-small cell lung carcinoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether adding targeted radiation therapy (SBRT or BgRT) to the few spots where cancer is progressing can help patients with EGFR-mutated non-small cell lung cancer (NSCLC) stay on their current targeted drug (osimertinib) for longer, even after limited progression. **You may be eligible if...** - You are 18 or older - You have confirmed NSCLC with a common EGFR mutation (exon 19 deletion or L858R) - You are currently on osimertinib and had stable disease for more than 6 months before your cancer began growing again in 1 to 5 spots outside the brain - You are in reasonably good health (ECOG ≤2) - Each organ has no more than 3 progressing lesions **You may NOT be eligible if...** - You have more than 5 sites of progression, or more than 3 lesions in any single organ - Your cancer has never responded to osimertinib - You have a different type of EGFR mutation not covered by this study - Your overall health is too poor to tolerate radiation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography

Undergo CT or PET/CT scan

DRUGOsimertinib

Given PO

PROCEDUREPositron Emission Tomography

Undergo PET/CT

RADIATIONStereotactic Body Radiation Therapy

Undergo BgRT/SBRT

OTHERSurvey Administration

Ancillary study


Locations(2)

City of Hope Medical Center

Duarte, California, United States

Yale University

New Haven, Connecticut, United States

View Full Details on ClinicalTrials.gov

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NCT06014827


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