Grid Radiotherapy for Advanced Non-Small Cell Lung Cancer at the Time of Progression on Immune Checkpoint Inhibition
Mayo Clinic
Summary
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.
Description
PRIMARY OBJECTIVE: I. To describe the safety and toxicity of grid + immunotherapy in stage IV NSCLC using any Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. SECONDARY OBJECTIVE: I. Evaluation of objective response rate using Immune-based Response Evaluation Criteria in Solid Tumors (iRECIST) in non-irradiated lesion(s) after grid therapy in the setting of ongoing immunotherapy. CORRELATIVE RESEARCH: I. Monitoring of peripheral blood T cell activation and immunity markers before and after grid therapy. II. Evaluation of objective response rate using RECIST in the i…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 en…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureComputed Tomography
Undergo CT
- OtherImmunotherapy
Given immunotherapy
- RadiationPalliative Radiation Therapy
Undergo palliative radiation therapy
- RadiationSpatially-fractionated Radiation Therapy
Undergo grid radiation therapy
Location
- Mayo Clinic in RochesterRochester, Minnesota