RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Roswell Park Cancer Institute • ClinicalTrials.gov ID: NCT07718672

Registry updated: 2026-08-26

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Description

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.

Interventions

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

Eligibility criteria

Inclusion 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 Exclusion 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

Conditions

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

Locations

Roswell Park Cancer Institute — Buffalo, New York, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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