NCT06014827

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To estimate the percent of patients receiving benefit at 6 months from the addition of BgRT/SBRT to first line osimertinib in EGFR positive non-small cell lung cancer (NSCLC) patients with oligoprogressive disease (disease control rate \[DCR\]). SECONDARY OBJECTIVES: I. To evaluate the tolerability of adding BgRT/SBRT to first line osimertinib in EGFR positive NSCLC patients with oligoprogressive disease. II. To estimate the overall survival when adding BgRT/SBRT to first line osimertinib in EGFR positive NSCLC patients with oligoprogressive disease. III. To describe the effect on quality of life (QOL) when adding BgRT/SBRT to first line osimertinib in EGFR positive NSCLC patients with oligoprogressive disease. IV. To describe the effect on quantified fludeoxyglucose F-18 (FDG) uptake changes when adding BgRT to first line osimertinib in EGFR positive NSCLC patients with oligoprogressive disease. V. To estimate local and distant control rates when adding BgRT/SBRT to first line osimertinib in EGFR positive NSCLC patients with oligoprogressive disease. VI. To estimate the extracranial progression free survival (PFS) when adding SBRT to first line osimertinib in EGFR positive NSCLC patients with oligoprogressive disease. VII. To estimate the time to treatment failure (TTF) when adding BgRT/SBRT to first line osimertinib in EGFR positive NSCLC patients with oligoprogressive disease. VII. To estimate percentage of patients needing salvage BgRT/SBRT when adding SBRT to first line osimertinib in EGFR positive NSCLC patients with oligoprogressive disease. EXPLORATORY OBJECTIVES: I. To identify potential predictors of outcome when adding BgRT/SBRT to first line osimertinib in EGFR positive NSCLC patients with oligoprogressive disease. II. To describe the changes in circulating tumor deoxyribonucleic acid (ctDNA) levels when adding BgRT/SBRT to first line osimertinib in EGFR positive NSCLC patients with oligoprogressive disease. OUTLINE: Patients continue to receive osimertinib orally (PO) daily (QD) in the absence of unacceptable toxicity. Patients undergo BgRT/SBRT every other day for 5 treatments. Patients then continue to receive osimertinib and are monitored via imaging. If additional progression is found, patients may receive additional BgRT/SBRT therapy. Treatment continues in the absence of \> 5 sites of progression, unacceptable toxicity, or the stopping of osimertinib for more than 4 weeks. Patients undergo computed tomography (CT) scan or positron emission tomography(PET)/CT scan and blood sample collection throughout the study. After completion of initial radiation therapy, patients follow up at 1 week, 3 months, 6 months and 12 months and then for an additional year.

Conditions

• Lung Non-Small Cell Carcinoma
• Stage IV Lung Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Computed Tomography	Undergo CT or PET/CT scan
DRUG	Osimertinib	Given PO
PROCEDURE	Positron Emission Tomography	Undergo PET/CT
RADIATION	Stereotactic Body Radiation Therapy	Undergo BgRT/SBRT
OTHER	Survey Administration	Ancillary study

Timeline

• Start date: 2024-10-09
• Primary completion: 2026-07-11
• Completion: 2026-07-11
• First posted: 2023-08-28
• Last updated: 2025-05-04

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study