Lung Non-Small Cell CarcinomaPhase 2NCT06660407
Grid Radiation Therapy for the Treatment of Stage IV Non-Small Cell Lung Cancer
A Phase 2 study testing Biospecimen Collection, Computed Tomography and Immunotherapy in people with Lung Non-Small Cell Carcinoma and Stage IV Lung Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
- What is being tested?
- Biospecimen Collection, Computed Tomography and Immunotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2024to 10 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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)
- Known active hepatitis B (i.e., known positive hepatitis B virus [HBV] surface antigen [HBsAg] reactive)
- Known active hepatitis C (i.e., positive for hepatitis C virus [HCV] ribonucleic acid [RNA] detected by polymerase chain reaction [PCR])
- Known active tuberculosis (TB)
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Unstable cardiac arrhythmia
- Psychiatric illness/social situations that would limit compliance with study requirements (e.g., substance abuse)
- History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- Hypersensitivity to immunotherapy
- Previous adverse event attributed to immunotherapy that led to drug discontinuation
- History of grade 3+ immune-related adverse event or any grade of immune-related neurologic or ocular adverse event while receiving immunotherapy
- Note: Patients who had endocrine adverse events ≤ grade 2 are allowed to enroll if they are stable on appropriate replacement therapy and asymptomatic
- Other active malignancy < 6 months prior to registration
- EXCEPTIONS: Non-melanotic skin cancer, papillary thyroid cancer, prostate cancer, or carcinoma-in-situ of the cervix, or others curatively treated and now considered to be at less than 30% risk of relapse
- History of allogenic organ transplantation
- History of active primary immunodeficiency
- Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice)
- Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc), at screening. Participants with a past or resolved HBV infection (defined as the presence of anti-HBc and absence of HBsAg) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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 irradiated lesion after grid therapy.
III. Evaluation of time to change in systemic therapy. IV. Evaluation of overall survival.
OUTLINE:
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 computed tomography (CT) at the discretion of the physician and undergo blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 30 days then every 8-12 weeks and every 3 months up to 5 years.
- Being tested
- Biospecimen Collection, Computed Tomography, Immunotherapy, Palliative Radiation Therapy, Spatially-fractionated Radiation Therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
ImmunotherapyOther
Also called Immunological, Immunological Therapy, Immunologically Directed Therapy
Given immunotherapy
Palliative Radiation TherapyRadiation
Also called Palliative Radiotherapy
Undergo palliative radiation therapy
Spatially-fractionated Radiation TherapyRadiation
Also called GRID Therapy, SFRT
Undergo grid radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Immunotherapy; Radiation: Palliative Radiation Therapy; Radiation: Spatially-fractionated Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 3 months post-grid treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start14 Nov 2024
- Primary completion10 Jan 2027 (estimated)
- Study completion10 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Non-Small Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dawn Owen, MD, PhD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660407
- Sponsor's protocol ID
- GMROR2221
- Other IDs
- 22-008589
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Grid Radiotherapy for Advanced Non-Small Cell Lung Cancer at the Time of Progression on Immune Checkpoint Inhibition
- ClinicalTrials.gov ID
- NCT06660407
- Acronym / sponsor ID
- GMROR2221
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- 10 Jan 2027 (estimated)
- Study completion
- 10 Jan 2027 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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 irradiated lesion after grid therapy.
III. Evaluation of time to change in systemic therapy. IV. Evaluation of overall survival.
OUTLINE:
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 computed tomography (CT) at the discretion of the physician and undergo blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 30 days then every 8-12 weeks and every 3 months up to 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (grid radiation therapy) | Experimental | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Other: Immunotherapy, Radiation: Palliative Radiation Therapy, Radiation: Spatially-fractionated Radiation TherapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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 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)
Key exclusion criteria (34 listed)
- 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
- Uncontrolled intercurrent illness including, but not limited to:
- History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Treatment (grid radiation therapy) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | Treatment (grid radiation therapy) |
| ImmunotherapyAlso: Immunological, Immunological Therapy, Immunologically Directed TherapyGiven immunotherapy | Other | Treatment (grid radiation therapy) |
| Palliative Radiation TherapyAlso: Palliative RadiotherapyUndergo palliative radiation therapy | Radiation | Treatment (grid radiation therapy) |
| Spatially-fractionated Radiation TherapyAlso: GRID Therapy, SFRTUndergo grid radiation therapy | Radiation | Treatment (grid radiation therapy) |
Primary outcome
Rate of grade 3+ adverse events
Time frame: Up to 3 months post-grid treatment
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.
1 secondary outcome
Objective response rate
Time frame: Up to 3 months post-grid treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn Owen, MD, PhD principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biospecimen Collection, Computed Tomography and Immunotherapy in people with Lung Non-Small Cell Carcinoma and Stage IV Lung Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of grade 3+ adverse events (time frame: Up to 3 months post-grid treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.