Trial Title:
Grid Radiation Therapy for the Treatment of Stage IV Non-Small Cell Lung Cancer
NCT ID:
NCT06660407
Condition:
Lung Non-Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Immunomodulating Agents
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Treatment (grid radiation therapy)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT
Arm group label:
Treatment (grid radiation therapy)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Other
Intervention name:
Immunotherapy
Description:
Given immunotherapy
Arm group label:
Treatment (grid radiation therapy)
Other name:
Immunological
Other name:
Immunological Therapy
Other name:
Immunologically Directed Therapy
Intervention type:
Radiation
Intervention name:
Palliative Radiation Therapy
Description:
Undergo palliative radiation therapy
Arm group label:
Treatment (grid radiation therapy)
Other name:
Palliative Radiotherapy
Intervention type:
Radiation
Intervention name:
Spatially-fractionated Radiation Therapy
Description:
Undergo grid radiation therapy
Arm group label:
Treatment (grid radiation therapy)
Other name:
GRID Therapy
Other name:
SFRT
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.
Detailed 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 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2
- Stage IV non-small cell lung cancer progressing on standard of care first line
immunotherapy or chemoimmunotherapy
- Patients have not had stereotactic body radiotherapy (SBRT) ≤ 30 days prior to
registration
- 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 to up to 2 other
metastatic sites (with at least one evaluable non-irradiated lesion)
- Hemoglobin ≥ 9.0 g/dL (obtained ≤ 15 days prior to enrollment)
- Absolute neutrophil count (ANC) ≥ 1500/mm^3 (obtained ≤ 15 days prior to enrollment)
- Platelet count ≥ 100,000/mm^3 (obtained ≤ 15 days prior to enrollment)
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) or direct bilirubin ≤ ULN if
total bilirubin is > 1.5 x ULN (obtained ≤ 15 days prior to enrollment)
- Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2.5 x ULN (≤ 5 x
ULN for patients with liver involvement) (obtained ≤ 15 days prior to enrollment)
- Creatinine ≤ 1.5 x ULN OR glomerular filtration rate (GFR) > 60 mL/min for patients
with creatinine > 1.5 x ULN (obtained ≤ 15 days prior to enrollment)
- Negative pregnancy test done ≤ 7 days prior to grid therapy, for females of
childbearing potential only
- Provide written informed consent
- Willing to provide mandatory blood specimens for correlative research
- Willing to return to Mayo Clinic for follow-up (during the Active Monitoring Phase
of the study)
- Estimated by investigator to have a life expectancy > 3 months
Exclusion Criteria:
- 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)
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Contact:
Last name:
Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Dawn Owen, MD, PhD
Email:
Principal Investigator
Start date:
January 15, 2025
Completion date:
January 10, 2027
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06660407
https://www.mayo.edu/research/clinical-trials
