Actively Recruiting
Phase II Trial of Adding Biologically Guided Radiation Therapy and Stereotactic Body Radiation Therapy to Osimertinib in EGFR Positive Non-Small Cell Lung Cancer with Limited Progression
Led by City of Hope Medical Center · Updated on 2026-05-07
32
Participants Needed
2
Research Sites
N/A
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
Researchers are studying how well biologically guided radiation therapy (BgRT) combined with stereotactic body radiation therapy (SBRT) and the drug osimertinib works to treat EGFR positive non-small cell lung cancer that has spread to a limited number of sites (oligoprogressive). This phase II trial aims to evaluate the benefit, tolerability, and survival outcomes of adding BgRT/SBRT to osimertinib for these patients. The study also looks at quality of life, tumor activity changes, and disease control rates. Participants continue taking osimertinib daily by mouth while receiving BgRT/SBRT treatments every other day for five sessions. After completing radiation therapy, patients are monitored with imaging scans and may receive additional BgRT/SBRT treatments if disease progresses but remains limited to fewer than five sites. Treatment stops if osimertinib is stopped for more than 4 weeks or if toxicity becomes unacceptable. Throughout the study, patients undergo CT or PET/CT scans and blood sample collections to monitor tumor response and safety. Follow-up visits occur at 1 week, 3 months, 6 months, 12 months, and for an additional year to assess outcomes. The primary measure is the percentage of patients benefiting from the combination treatment at 6 months, with secondary measures including survival, quality of life, and disease progression rates.
CONDITIONS
Brief 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
Eligibility Criteria
You may qualify if you...
- Participant or legally authorized representative has provided documented informed consent
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) score of 2 or less
- Histologically confirmed advanced non-small cell lung cancer
- Tumor has common EGFR mutations Ex19del or L858R, alone or with other EGFR mutations including T790M
- Disease progression in metastatic setting on PET or CT imaging after stable disease on first line osimertinib for more than 6 months
- Progression in 1 to 5 extracranial sites with the primary tumor treated with curative or local control intent
- Maximum of 3 lesions per organ
- Brain metastases must be treated, asymptomatic, and off steroids for at least 1 week
- Lesions must be suitable for stereotactic body radiation therapy (SBRT) with minimum dose criteria
- At least one lesion suitable for biologically guided radiation therapy (BgRT), at least 2 cm in lung or bone
- No prior systemic therapy for advanced disease except osimertinib
- Women of childbearing potential must have negative pregnancy test
- Agreement to use effective birth control or abstain during and 4 months after study
- Ability to swallow and retain oral medications
- Life expectancy of at least 6 months
You will not qualify if you...
- Chemotherapy, radiation therapy, biological therapy, or immunotherapy within 21 days prior to study treatment (exceptions: brain radiation 2 weeks, osimertinib)
- Use of strong CYP3A4 inducers or inhibitors within 14 days prior to study
- Use of class 1A or III antiarrhythmic agents within 14 days prior to study
- Use of drugs known to prolong QTc interval
- History of allergic reactions to similar compounds
- Clinically significant uncontrolled illness
- Active infection requiring systemic antibiotics
- Known HIV or hepatitis B or C infection
- Prior malignancy within 5 years except certain low-risk cancers
- Pregnant or breastfeeding females
- Malabsorption conditions
- Any other condition deemed unsafe for participation
- Congenital long QT syndrome
- Severe cardiac disease or recent myocardial infarction
- Untreated or symptomatic central nervous system metastases
- Active or steroid-treated interstitial lung disease or pneumonitis
- Inability to comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Variable, until disease progression or unacceptable toxicity
Participants continue to receive osimertinib daily by mouth. They undergo biologically guided radiation therapy (BgRT) and stereotactic body radiation therapy (SBRT) every other day for 5 treatments. If disease progression occurs, additional BgRT/SBRT may be given. Treatment continues unless there are more than 5 progression sites, unacceptable toxicity, or osimertinib is stopped for more than 4 weeks.
5 radiation therapy sessions every other day, with ongoing oral medication and imaging assessments
Duration - Up to 2 years
After completing initial radiation therapy, participants are monitored with imaging and blood sample collection. Follow-up visits occur at 1 week, 3 months, 6 months, 12 months, and then for an additional year to assess treatment outcomes and side effects.
Visits at 1 week, 3 months, 6 months, 12 months, and additional visits over the following year
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
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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