Grid Radiotherapy for Advanced Non-Small Cell Lung Cancer at the Time of Progression on Immune Checkpoint Inhibition
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.
• Age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2
• Stage IV non-small cell lung cancer progressing on standard of care first line immunotherapy or chemoimmunotherapy
• Patients have not had stereotactic body radiotherapy (SBRT) ≤ 30 days prior to registration
• 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 to up to 2 other metastatic sites (with at least one evaluable non-irradiated lesion)
• Hemoglobin ≥ 9.0 g/dL (obtained ≤ 15 days prior to enrollment)
• Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained ≤ 15 days prior to enrollment)
• Platelet count ≥ 100,000/mm\^3 (obtained ≤ 15 days prior to enrollment)
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN) or direct bilirubin ≤ ULN if total bilirubin is \> 1.5 x ULN (obtained ≤ 15 days prior to enrollment)
• Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 15 days prior to enrollment)
• Creatinine ≤ 1.5 x ULN OR glomerular filtration rate (GFR) \> 60 mL/min for patients with creatinine \> 1.5 x ULN (obtained ≤ 15 days prior to enrollment)
• Negative pregnancy test done ≤ 7 days prior to registration for females of childbearing potential only
• Provide written informed consent
• Willing to provide mandatory blood specimens for correlative research
• Willing to return to Mayo Clinic for follow-up (during the Active Monitoring Phase of the study)
• Estimated by investigator to have a life expectancy \> 3 months