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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Immunotherapy

    Other intervention

    Given immunotherapy

  • Palliative Radiation Therapy

    Radiation

    Undergo palliative radiation therapy

  • Spatially-fractionated Radiation Therapy

    Radiation

    Undergo grid radiation therapy

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Treatment (grid radiation therapy)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 3 months post-grid treatment

Secondary outcomes

1

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.

Time frame
Up to 3 months post-grid treatment

Other outcomes

Sponsors and contacts

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