Recruiting
Phase 2

SBRT vs. Standard SBRT

Sponsor:

Roswell Park Cancer Institute

Code:

NCT07718672

Conditions

Early Stage Lung Non-Small Cell Carcinoma

Stage I Lung Cancer AJCC v8

Stage II Lung Cancer AJCC v8

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Computed Tomography

Lymph Node Biopsy

Positron Emission Tomography

Stereotactic Body Radiation Therapy

Study Details

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

Study ID

NCT07718672

Start date

Sep 1, 2026

Status verified date

Aug, 2026

Completion date

Sep 1, 2029

Anticipated

Primary completion date

Jun 25, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Aim II (hot spot SBRT)

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.

experimental: Arm I (SOC SBRT)

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.

Interventions

Biospecimen Collection

Undergo blood sample collection

Computed Tomography

Undergo CT scan

Lymph Node Biopsy

Undergo lymph node sampling

Positron Emission Tomography

Undergo PET scan

Stereotactic Body Radiation Therapy

Receive SOC SBRT

Stereotactic Body Radiation Therapy

Receive hot spot SBRT

Survey Administration

Ancillary studies

Primary outcome measure

  • Time to progression (local control) [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Locations

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

ASK Roswell

800-767-9355AskRoswell@Roswellpark.org

Principal Investigator:

Mark Farrugia

More Information

Sponsor

Roswell Park Cancer Institute

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Roswell Park Cancer Institute on 2026-08-26.