Actively Recruiting
Grid Radiation Therapy for the Treatment of Stage IV Non-Small Cell Lung Cancer
Led by Mayo Clinic · Updated on 2026-04-13
20
Participants Needed
1
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial tests the safety and effectiveness of the combination of grid radiation therapy and standard of care (SOC) immunotherapy in treating patients with stage IV non-small lung cancer (NSCLC). Conventional radiation therapy treatments typically deliver the same radiation dose to the entire tumor. Spatially fractionated radiation therapy or grid therapy is approved and a technique which permits the delivery of high doses of radiation to small regions of the tumor which can lead to enhanced tumor cell killing. Grid therapy has been shown to produce dramatic relief of severe symptoms, significant tumor regression (decrease in the size of a tumor), and above average local control rates often exceeding those expected with conventionally delivered radiation treatments, all with minimal associated toxicity. Immunotherapy has become combined into treating patients, which has led improvements in survival and quality of life. Immunotherapy is now the cornerstone of SOC therapy for stage IV NSCLC. Grid radiation therapy combined with immunotherapy may be safe and effective in treating patients with stage IV NSCLC.
CONDITIONS
Official Title
Grid Radiation Therapy for the Treatment of Stage IV Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Stage IV non-small cell lung cancer progressing after immunotherapy or chemoimmunotherapy
- Presence of an extracranial lesion 3 cm or larger suitable for grid therapy
- Brain metastases allowed if stable without progression within 30 days prior to enrollment, no new or enlarging brain metastases, and no steroid use within 14 days prior to enrollment
- Patients may receive conventional palliative radiation or stereotactic body radiotherapy to other metastatic sites if there is at least one non-irradiated lesion that can be evaluated for response
- Negative pregnancy test within 7 days prior to radiation therapy for females of childbearing potential
- Ability to provide written informed consent
- Willingness to provide mandatory blood samples for correlative research
- Willingness to return to Mayo Clinic for follow-up or have virtual visits and local blood draws during active monitoring phase
- Estimated life expectancy greater than 3 months as judged by investigator
You will not qualify if you...
- Severe co-morbid illnesses or diseases that would interfere with safety assessment or study participation
- Active autoimmune disease requiring systemic treatment or history of severe autoimmune disease needing systemic steroids or immunosuppressive agents, except for specified exceptions (e.g., vitiligo, resolved childhood asthma, stable hypothyroidism)
- Uncontrolled illness including active infection requiring systemic therapy, interstitial lung disease, serious gastrointestinal conditions causing diarrhea, active hepatitis B or C infection, active tuberculosis, symptomatic congestive heart failure, unstable angina, or unstable cardiac arrhythmia
- Psychiatric illness or social situations limiting compliance (e.g., substance abuse)
- History of myocardial infarction within 6 months or congestive heart failure requiring ongoing treatment for life-threatening arrhythmias
- Use of any other investigational agent targeting the primary cancer
- Known hypersensitivity to immunotherapy
- Previous immunotherapy adverse event leading to drug discontinuation
- History of grade 3 or higher immune-related adverse event or any grade of immune-related neurologic or ocular adverse event from immunotherapy, except stable endocrine adverse events grade 2 or less on replacement therapy
- Other active malignancy within 6 months prior to registration, except certain treated cancers with low relapse risk
- History of allogenic organ transplantation
- History of active primary immunodeficiency
- Known positive HIV infection or active tuberculosis infection
- Active hepatitis infection at screening, positive hepatitis C antibody, hepatitis B surface antigen or core antibody, except past or resolved hepatitis B infection and negative hepatitis C RNA by PCR
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
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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