RecruitingPhase 2NCT07718672
Official study title

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

Study 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.

Ask AI to explain this study
Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedBiospecimen Collection and Computed Tomography

Plus 5 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 26, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Roswell Park Cancer Institute

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Roswell Park Cancer Institute
Interventions being studied
Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Lymph Node Biopsy; Procedure: Positron Emission Tomography; Radiation: Stereotactic Body Radiation Therapy; Radiation: Stereotactic Body Radiation Therapy; Other: Survey Administration
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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
Reasons someone may not be able to joinExclusion criteria
  • 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Roswell Park Cancer InstituteBuffalo, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 26, 2026. Always confirm current availability with the study team.

View original record ↗