Grid Radiation Therapy for the Treatment of Stage IV Non-Small Cell Lung Cancer

Recruiting now · Phase 2

Conditions studied: Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8

In brief

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.

Key facts

Study ID

NCT06660407

Run by

Mayo Clinic

People needed

20

Starts

2024-11-14

Expected to finish

2027-01-10

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2
• Stage IV non-small cell lung cancer progressing after immunotherapy or chemoimmunotherapy
• Extracranial lesion ≥ 3 cm amenable to grid therapy
• Patients with brain metastases are permitted to enroll if all of the following are true:
• They are stable (without evidence of progression by imaging ≤ 30 days prior to enrollment and any neurologic symptoms have returned to baseline)
• Have no evidence of new or enlarging brain metastases, and
• Are not using steroids ≤ 14 days prior to enrollment
• Patients may receive conventional palliative radiation or stereotactic body radiotherapy (SBRT) to other metastatic sites (provided there is at least one non-irradiated lesion evaluable for response)
• Negative pregnancy test done ≤ 7 days prior to radiation therapy for females of childbearing potential only
• Provide written informed consent
• Willing to provide mandatory blood specimens for correlative research
• Willing to either return to Mayo Clinic for follow-up (during the Active Monitoring Phase of the study) or willing to have virtual visits and blood draws done locally
• Estimated by investigator to have a life expectancy > 3 months

You may not qualify if…

• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• Active autoimmune disease requiring systemic treatment, documented history of severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
• NOTE: Exceptions are allowed for:
• Vitiligo
• Resolved childhood asthma/atopy
• Intermittent use of bronchodilators or inhaled steroids
• Daily steroids at dose of ≤ 10mg of prednisone (or equivalent)
• Local steroid injections
• Stable hypothyroidism on replacement therapy
• Stable diabetes mellitus on non-insulin therapy
• Sjogren's syndrome
• Uncontrolled intercurrent illness including, but not limited to:
• Ongoing or active infection requiring systemic therapy
• Interstitial lung disease
• Serious, chronic gastrointestinal conditions associated with diarrhea (e.g., Crohn's disease or others)
• Known active hepatitis B (i.e., known positive hepatitis B virus [HBV] surface antigen [HBsAg] reactive)
• Known active hepatitis C (i.e., positive for hepatitis C virus [HCV] ribonucleic acid [RNA] detected by polymerase chain reaction [PCR])
• Known active tuberculosis (TB)
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Unstable cardiac arrhythmia
• Psychiatric illness/social situations that would limit compliance with study requirements (e.g., substance abuse)
• History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
• Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
• Hypersensitivity to immunotherapy

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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