An Early Phase 1 interventional study of Laboratory Biomarker Analysis and Quality-of-Life Assessment in Stage I Non-Small Cell Lung Cancer AJCC v7, Stage IA Non-Small Cell Lung Carcinoma AJCC v7 and Stage IB Non-Small Cell Lung Carcinoma AJCC v7, sponsored by Roswell Park Cancer Institute. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-02.
Sponsored by Roswell Park Cancer Institute · Early Phase 1, Interventional, and Treatment
This pilot clinical trial studies the effects of stereotactic body radiation therapy followed by surgery in treating patients with stage I-IIIA non-small cell lung cancer. Stereotactic body radiation therapy is a method of radiation that uses imaging to precisely locate a tumor and then deliver very high radiation doses to the tumor site in order to limit normal tissue toxicity or damage.
PRIMARY OBJECTIVES:
I. To assess the safety and feasibility of combining single fraction stereotactic body radiation therapy (SBRT) followed by surgery, in thoracic malignancies.
SECONDARY OBJECTIVES:
I. To estimate overall survival (OS) and progression-free survival (PFS) after single fraction SBRT followed by surgery, in thoracic malignancies.
II. To define any differences in quality of life/toxicity following SBRT based on tumor location/stage/tumor type.
TERTIARY OBJECTIVES:
I. To assess changes in T cell mediated immunity following SBRT in thoracic malignancies.
OUTLINE: Patients are assigned to 1 of 3 studies.
STUDY 1: Patients with stage I or II non-small cell lung cancer (NSCLC) in the peripheral lung undergo highest-dose of SBRT over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
STUDY 2: Patients with stage I or II NSCLC in the central lung undergo lowest-dose of SBRT over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
STUDY 3: Patients with stage IIIA NSCLC in the any lung location undergo lowest- or higher-dose of SBRT over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
After completion of study treatment, patients are followed up at 6, 9, and 12 months, every 6 months for 2 years, and then annually for 2 years.
Have histologically proven diagnosis of: non-small cell lung cancer (NSCLC) (stage I, II, or IIIa)
Participant is able to undergo surgery (planned lobectomy or wedge resection)
Exclusion Criteria:
Patients with stage I or II NSCLC in the peripheral lung undergo highest-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
Other: Laboratory Biomarker Analysis · Other: Quality-of-Life Assessment · Drug: Stereotactic Body Radiation Therapy · Procedure: Thoracic Surgical Procedure
Patients with stage I or II NSCLC in the central lung undergo lowest-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
Other: Laboratory Biomarker Analysis · Other: Quality-of-Life Assessment · Drug: Stereotactic Body Radiation Therapy · Procedure: Thoracic Surgical Procedure
Patients with stage IIIA NSCLC in the any lung location undergo lowest- or higher-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
Other: Laboratory Biomarker Analysis · Other: Quality-of-Life Assessment · Drug: Stereotactic Body Radiation Therapy · Procedure: Thoracic Surgical Procedure
Correlative studies
Ancillary studies
Also known as: Quality of Life Assessment
Undergo lowest-dose of SBRT
Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Undergo lowest- or higher-dose of SBRT
Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Undergo highest-dose of SBRT
Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Undergo thoracic surgery
Also known as: Chest Surgery, Thoracic Surgery, Thoracic Surgical Procedures
Incidence of treatment-related grade 3-5 adverse events assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0
Comparison will be made with published historical and contemporaneous rates of toxicity with standard of care therapy for each of the study groups.
Time frame: Up to 10 weeks post-surgery
Overall survival
Will be measured and compared with published historical and contemporaneous rates of toxicity with standard of care therapy for each of the study groups.
Time frame: Up to 5 years
Progression free survival
Will be measured and compared with published historical and contemporaneous rates of toxicity with standard of care therapy for each of the study groups.
Time frame: Up to 5 years
Change in the mediators of tumor antigen presentation, co-stimulatory molecules, and immune effector cell populations assessed using multicolor flow cytometry, immunohistochemistry, and enzyme-linked immunosorbent assay (ELISA)
Defined as CD4+ and CD8+ T-cells, T-regulatory cells (CD4+CD25+FoxP3+), natural killer cells, monocytes, macrophages, dendritic cells and myeloid derived suppressor cells. The study groups will be compared with age, sex, and stage matched controls. Immunohistochemistry results, flow cytometry results and ELISA results will be tabulated as percent change pre/post-radiation, and pre/post-thoracic surgery. The effects of these interventions will be assessed using permutation paired t-test, with multiplicity adjustments to maintain a 10% false discovery rate. Adjusted effect sizes will be obtained
Time frame: Baseline up to 10 weeks post-surgery
Factors associated with T cell immunity in pathologic specimens
Comparison will be made to similar, blinded samples from patients who received surgery alone (by means of standard Lung DSRG approval).
Time frame: After surgery
Incidence of adverse events assessed using the NCI CTCAE v4.0
Will be stratified by type of surgery (wedge resection, lobectomy, open versus thoracoscopic, and pneumonectomy).
Time frame: Up to 10 weeks post-surgery
This study is terminated, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Roswell Park Cancer Institute