Study on Biologically Guided Radiation Therapy and Stereotactic Body Radiation Therapy with Osimertinib for Treating EGFR Positive Non-Small Cell Lung Cancer

Sponsor: City of Hope Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06014827

Provider View

This clinical trial is exploring a new treatment approach for patients with EGFR positive non-small cell lung cancer that has spread to a few areas. The study combines two types of precise radiation therapy with a medication called osimertinib to see if it can better control the cancer.

Patient Parameters

Program Overview

This study is testing a combination of biologically guided radiation therapy (BgRT) and stereotactic body radiation therapy (SBRT) with the drug osimertinib for treating non-small cell lung cancer (NSCLC) that is EGFR positive and has spread to a limited number of sites. BgRT uses advanced imaging to target active tumors, while SBRT delivers precise radiation to tumors, potentially reducing side effects. Osimertinib is a medication that blocks a protein called EGFR, which helps slow down or stop cancer cell growth. The goal is to see if this combination can kill more cancer cells in patients with this type of lung cancer.

Description

The main goal of this study is to see how many patients benefit from adding BgRT and SBRT to osimertinib after 6 months. Researchers will also look at how well patients tolerate this combination, how it affects their quality of life, and how it impacts their overall survival. The study will also explore changes in cancer activity and how long patients can go without their cancer getting worse.

Participants will continue taking osimertinib daily and receive BgRT/SBRT every other day for 5 treatments. They will be monitored with imaging scans and blood tests. If the cancer progresses, additional BgRT/SBRT may be given. The treatment will continue unless there are more than 5 sites of cancer progression, unacceptable side effects, or if osimertinib is stopped for more than 4 weeks.

After the initial radiation therapy, follow-up visits will occur at 1 week, 3 months, 6 months, and 12 months, with additional follow-ups for another year.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent to participate.
  • Age 18 years or older.
  • Good overall health with an ECOG score of 0 to 2.
  • Diagnosed with advanced non-small cell lung cancer (NSCLC) that is EGFR positive.
  • Cancer must have progressed in a limited number of sites after initial treatment with osimertinib.
  • Must have 1 to 5 sites of cancer outside the brain that can be treated with radiation.
  • At least one tumor must be suitable for BgRT.
  • No previous systemic therapy for advanced cancer other than osimertinib.
  • Women of childbearing potential must have a negative pregnancy test and agree to use birth control.
  • Must be able to swallow pills.
  • Expected to live at least 6 months.

Exclusion Criteria

  • Recent chemotherapy, radiation, or other cancer treatments within 21 days, except for brain radiation and osimertinib.
  • Use of certain medications that affect heart rhythm or interact with the study drug.
  • History of severe allergic reactions to similar drugs.
  • Uncontrolled illness or active infections.
  • Known HIV or hepatitis B/C infection.
  • Other cancers unless treated and in remission for 5 years, with some exceptions.
  • Pregnant or breastfeeding women.
  • Conditions affecting drug absorption.
  • Heart conditions or recent heart attack.
  • Active brain cancer or untreated brain metastases.
  • Lung diseases like interstitial lung disease or pneumonitis.
  • Any condition that may prevent following study procedures.

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