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

NCT06660407 | Recruiting Phase 2

• 2 other identifiers: GMROR222122-008589
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8

Outcome Measures

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.

  Up to 3 months post-grid treatment

Secondary Outcomes (1)

• Objective response rate

  Up to 3 months post-grid treatment

Study Arms (1)

Treatment (grid radiation therapy)

EXPERIMENTAL

Patients undergo grid radiation therapy over a single fraction on day 1 and palliative radiation therapy over 5 fractions on days 2 and -1 post-grid in the absence of disease progression or unacceptable toxicity. Patients also receive SOC immunotherapy and undergo CT at the discretion of the physician and undergo blood sample collection throughout the study.

Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Immunotherapy; Radiation: Palliative Radiation Therapy; Radiation: Spatially-fractionated Radiation Therapy

Interventions

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Treatment (grid radiation therapy)

Immunotherapy OTHER

Given immunotherapy

Also known as: Immunological, Immunological Therapy, Immunologically Directed Therapy

Treatment (grid radiation therapy)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (grid radiation therapy)

Palliative Radiation Therapy RADIATION

Undergo palliative radiation therapy

Also known as: Palliative Radiotherapy

Treatment (grid radiation therapy)

Spatially-fractionated Radiation Therapy RADIATION

Undergo grid radiation therapy

Also known as: GRID Therapy, SFRT

Treatment (grid radiation therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Specimen Handling; Immunotherapy; Adjuvants, Immunologic

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Dawn Owen, MD, PhD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 28, 2024
• Study Start: November 14, 2024
• Primary Completion (Estimated): January 10, 2027
• Study Completion (Estimated): January 10, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (1)