About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Vitiligo
Resolved childhood asthma/atopy
Trial design
Single group
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Computed Tomography
Procedure/SurgeryUndergo CT
Immunotherapy
Other interventionGiven immunotherapy
Palliative Radiation Therapy
RadiationUndergo palliative radiation therapy
Spatially-fractionated Radiation Therapy
RadiationUndergo grid radiation therapy
Treatment groups
Trial outcomes
Primary outcomes
Rate of grade 3+ adverse events
Will be assessed using any Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Will not utilize a formal statistical design. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be provided. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. Will be considered official if the rate is less than 40% possibly related to study treatment.
Secondary outcomes
Objective response rate
Will be defined as the number of evaluable patients achieving a response (partial response or better) during treatment with study therapy divided by the total number of evaluable patients. Will be estimated using the Immune-based Response Evaluation Criteria in Solid Tumors in non-irradiated lesion(s) after grid therapy. Point estimates will be generated with 90% confidence intervals using Fisher's exact method. Graphical methods will be used as well, such as waterfall plots.
Sponsors and contacts
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