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

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment200 people
  • Recruiting US sites1
  • SponsorRoswell Park Cancer Institute
  • RegistryNCT07718672

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

Hotspot Stereotactic Ablative Radiotherapy Versus Traditional Stereotactic Ablative Radiotherapy for the Treatment of Early-Stage Non-Small Cell Lung Cancer: a one-minute explainerNCT077186721 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to no maximum
  • SexAll
  • Healthy volunteersNo

You may be able to join 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 cannot join 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

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

  • Biospecimen Collection (Procedure): Undergo blood sample collection
  • Computed Tomography (Procedure): Undergo CT scan
  • Lymph Node Biopsy (Procedure): Undergo lymph node sampling
  • Positron Emission Tomography (Procedure): Undergo PET scan
  • Stereotactic Body Radiation Therapy (Radiation): Receive SOC SBRT
  • Stereotactic Body Radiation Therapy (Radiation): Receive hot spot SBRT
  • Survey Administration (Other): Ancillary studies

The study

Treatment groups

Randomized · Parallel · masking: None

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.

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.

What it involves

Procedures

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

  • biopsy: Part of the study plan
  • blood samples: Part of the study plan
  • CT scans: Part of the study plan
  • PET scans: Part of the study plan
  • questionnaires: Part of the study plan
  • radiation: Part of the study plan

Goals

What the study measures

Main goals

  • Time to progression (local control) (Up to 2 years)

Other goals

  • Progression free survival (PFS)
  • Overall survival (OS)
  • Time to progression (local control) in a size-dependent manner
  • PFS for patients who are already taking a beta blocker
  • Perception of Stress using Perceived Stress Scale
  • Change in Quality of life
  • Incidence of grade 3+ adverse events

Planned enrollment: 200 (estimated).

Where

Recruiting US sites

  • Roswell Park Cancer Institute, Buffalo, New York

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Aug 25, 2026. Public record; not medical advice.

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