Hotspot Stereotactic Ablative Radiotherapy Versus Traditional Stereotactic Ablative Radiotherapy for the Treatment of Early-Stage Non-Small Cell Lung Cancer

NCT07718672 | Not Yet Recruiting Phase 2 FDA Drug

• 2 other identifiers: I-4050824NCI-2026-04889
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial compares stereotactic ablative radiotherapy (SBRT) with hot spots to standard of care SBRT for the treatment of patients with early-stage non-small cell lung cancer. SBRT with hot spots intentionally makes sure the tumor gets a higher radiation dose during treatment. This potentially may result in better control of the tumor, but also more side effects. SBRT with or without hot spots may be more effective in treating patients with early-stage non-small cell lung cancer, compared to standard of care SBRT.

Conditions

Early Stage Lung Non-Small Cell Carcinoma; Stage I Lung Cancer AJCC v8; Stage II Lung Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• Time to progression (local control)

  Defined as no failure within the radiotherapy planning target volume (PTV), based on the international consensus on assessing local failure after stereotactic ablative radiotherapy (SBRT) will be utilized. The 2-year local control rates will be summarized by treatment arms using 90% Clopper-Pearson confidence intervals. The local control rates between arms will be compared using one-sided Cochrane-Mantel-Haenszel test (alpha=0.1), stratified by performance status, surgery candidacy, and beta-blocker usage.

  Up to 2 years

Secondary Outcomes (7)

• Progression free survival (PFS)

  From the start of treatment to first documented disease progression, or death due to any cause, up to 3 years

• Overall survival (OS)

  From the start of treatment to patient death due to any cause, up to 3 years

• Time to progression (local control) in a size-dependent manner

  Up to 3 years

• PFS for patients who are already taking a beta blocker

  Up to 3 years

• Perception of Stress using Perceived Stress Scale

  Up to 3 years

Study Arms (2)

Aim II (hot spot SBRT)

EXPERIMENTAL

Patients receive hot spot SBRT for 1-5 fractions over 1-11 days, in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan with or without PET scan and blood sample collection throughout the study. Patients may undergo lymph node sampling throughout the study.

Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Lymph Node Biopsy; Procedure: Positron Emission Tomography; Radiation: Stereotactic Body Radiation Therapy; Other: Survey Administration

Arm I (SOC SBRT)

EXPERIMENTAL

Patients receive SOC SBRT for 1-5 fractions over 1-11 days, in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan with or without PET scan and blood sample collection throughout the study. Patients may undergo lymph node sampling throughout the study.

Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Lymph Node Biopsy; Procedure: Positron Emission Tomography; Radiation: Stereotactic Body Radiation Therapy; Other: Survey Administration

Interventions

Computed Tomography PROCEDURE

Undergo CT scan

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, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Aim II (hot spot SBRT); Arm I (SOC SBRT)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

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

Aim II (hot spot SBRT); Arm I (SOC SBRT)

Positron Emission Tomography PROCEDURE

Undergo PET scan

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Aim II (hot spot SBRT); Arm I (SOC SBRT)

Lymph Node Biopsy PROCEDURE

Undergo lymph node sampling

Also known as: Biopsy of Lymph Node

Aim II (hot spot SBRT); Arm I (SOC SBRT)

Stereotactic Body Radiation Therapy RADIATION

Receive SOC SBRT

Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

Arm I (SOC SBRT)

Survey Administration OTHER

Ancillary studies

Aim II (hot spot SBRT); Arm I (SOC SBRT)

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
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
• Diagnosed with T1-3N0 biopsy-proven NSCLC of the lung. Multiple primary lung tumors are allowed; however, each lesion requires histologic confirmation
• Metachronous lung tumors as defined as a new lung lesion in the setting of a historically treated lung cancer are allowed under certain conditions. The previous lung cancer must have been treated greater than 6 months prior to protocol therapy and this cancer must be considered controlled
• Eligible for SABR
• Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
• Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

You may not qualify if:

• Patients with a history of a prior lung cancer will be excluded only if the previous treatment is within 6 months of the protocol therapy
• Mixed small cell and non-small cell lung cancer
• History of allogeneic organ transplantation
• History of primary immunodeficiency
• Patients must not have undergone prior radiation to overlapping regions of the chest that, in the opinion of the treatment physician, will interfere with protocol treatment
• Active autoimmune disease that has required systemic treatment in the last 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
• Known EGFR or ALK mutation
• Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
• Pregnant or nursing female participant
• Unwilling or unable to follow protocol requirements

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Specimen Handling; Sentinel Lymph Node Biopsy; Magnetic Resonance Spectroscopy; Radiosurgery

Condition Hierarchy (Ancestors)

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; Biopsy; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Spectrum Analysis; Chemistry Techniques, Analytical; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures

Study Officials

• Mark Farrugia

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 22, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 25, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: July 22, 2026

Record last verified: 2026-07

Locations

US (1)