Actively Recruiting

Phase 2
Age: 18Years +
All Genders
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

Led by City of Hope Medical Center · Updated on 2026-05-07

32

Participants Needed

2

Research Sites

91 weeks

Total Duration

On this page

Sponsors

C

City of Hope Medical Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Documented informed consent given by the participant or legally authorized representative
  • Age 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
  • Histologically confirmed advanced non-small cell lung cancer (NSCLC)
  • Tumor has common EGFR mutations associated with sensitivity to EGFR tyrosine kinase inhibitors (Ex19del or L858R), alone or with other EGFR mutations
  • Disease progression in metastatic setting on PET or CT imaging while receiving first-line osimertinib after stable disease for more than 6 months
  • Progression involves 1 to 5 extracranial sites; maximum 3 lesions per organ
  • Brain metastases, if present, must be treated, asymptomatic, off steroids for at least 1 week, and radiation completed 2 weeks prior to study start
  • Lesions must be suitable for stereotactic body radiation therapy (SBRT)
  • At least one lesion suitable for biologically guided radiation therapy (BgRT), including a lung or bone metastasis ≥ 2 cm
  • No prior systemic therapy for advanced disease except osimertinib
  • Women of childbearing potential must have negative pregnancy test and agree to use effective birth control or abstain from heterosexual activity during the study and for 4 months after
  • Participants able to swallow and retain oral medications
  • Life expectancy of at least 6 months
Not Eligible

You will not qualify if you...

  • Chemotherapy, radiation, biological therapy, or immunotherapy within 21 days prior to study start (except brain radiation 2 weeks prior and osimertinib)
  • Use of strong CYP3A4 inducers or inhibitors within 14 days prior to study start
  • Use of class 1A or class III antiarrhythmic agents within 14 days prior to study start
  • Use of drugs that prolong corrected QT interval
  • History of allergic reactions to similar compounds as study agent
  • Clinically significant uncontrolled illness
  • Active infection requiring systemic antibiotics, antiviral, or antifungal therapy
  • Known HIV or hepatitis B or C infection
  • Prior malignancy except carcinoma in situ of cervix or nonmelanoma skin cancer unless treated over 5 years ago without recurrence; localized low-grade prostate cancer allowed
  • Pregnant or breastfeeding females
  • Any malabsorption condition
  • Conditions that contraindicate study participation due to safety concerns
  • Diagnosis of congenital long QT syndrome
  • Severe cardiac disease or recent myocardial infarction
  • Untreated or symptomatic central nervous system metastases or leptomeningeal carcinomatosis
  • Active or history of interstitial lung disease or pneumonitis requiring steroids
  • Inability to comply with study procedures due to feasibility or logistics

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

City of Hope Medical Center

Duarte, California, United States, 91010

Actively Recruiting

2

Yale University

New Haven, Connecticut, United States, 06520

Not Yet Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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