Early Stage Lung Non-Small Cell CarcinomaPhase 2NCT07718672
Hotspot Stereotactic Ablative Radiotherapy Versus Traditional Stereotactic Ablative Radiotherapy for the Treatment of Early-Stage Non-Small Cell Lung Cancer
A Phase 2 study testing Biospecimen Collection, Computed Tomography and Lymph Node Biopsy in people with Early Stage Lung Non-Small Cell Carcinoma and Stage I Lung Cancer AJCC v8, run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Stage Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8
- What is being tested?
- Biospecimen Collection, Computed Tomography and Lymph Node Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 1 Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
ASK Roswell, 800-767-9355, AskRoswell@Roswellpark.org
Mark Farrugia
About this study
Official title: (PRESTO) A Randomized Phase II Trial Evaluating Hotspots in Stereotactic Ablative Radiotherapy for Early-Stage Non-Small Cell Lung Cancer
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.
Read the detailed description
PRIMARY OBJECTIVE:
- Evaluate the impact of incorporating high isodoses termed "hot spots" in radiation therapy planning on local control.
SECONDARY OBJECTIVES:
- Evaluate the impact of "hot spots" in radiation therapy planning on progression-free survival (PFS).
II. Evaluate the impact of "hot spots" in radiation therapy planning on overall survival (OS).
III. Evaluate the impact of tumor size on local control and if hotspot grouping impacts local control in a size-dependent manner.
IV. To prospectively evaluate the PFS in early stage-non small cell lung cancer (ES-NSCLC) patients undergoing SABR who are already taking a beta-blocker as well as a potential interaction between beta-blocker usage and the perceived stress scale.
- Will evaluate for any potential interactions between quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer [EORTC QLQ-LC13]) and hotspot grouping.
VI. Evaluate the impact of "hot spots" in radiation therapy planning on toxicity by total number of grade 3+ adverse effects.
EXPLORATORY OBJECTIVE:
- Change in immune cell marker levels at week 12 post-SBRT (± 1 week) versus baseline, such as mediators of tumor antigen presentation, costimulatory molecules, immune effector cell populations, including CD4+ and CD+8 T-cells, T regulatory cells (CD4+CD25+FoxP3+), natural killer (NK) cells, monocytes, macrophages, dendritic cells (DCs) and myeloid derived suppressor cells (MDSCs).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard of care (SOC) SBRT for 1-5 fractions over 1-11 days, in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan with or without positron emission tomography (PET) scan and blood sample collection throughout the study. Patients may undergo lymph node sampling throughout the study.
ARM II: 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.
After completion of study treatment, patients are followed up every 3 months for 1 year and then every 3-6 months up to month 36.
- Conditions
- Early Stage Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8
- Being tested
- Biospecimen Collection, Computed Tomography, Lymph Node Biopsy, Positron Emission Tomography, Stereotactic Body Radiation Therapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo blood sample collection
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT scan
Lymph Node BiopsyProcedure or surgery
Also called Biopsy of Lymph Node
Undergo lymph node sampling
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET scan
Stereotactic Body Radiation TherapyRadiation
Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Receive SOC SBRT
Stereotactic Body Radiation TherapyRadiation
Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Receive hot spot SBRT
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Lymph Node Biopsy; Procedure: Positron Emission Tomography; Radiation: Stereotactic Body Radiation Therapy; Other: Survey Administration |
| 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. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Lymph Node Biopsy; Procedure: Positron Emission Tomography; Radiation: Stereotactic Body Radiation Therapy; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression (local control)
Defined as no failure within the radiotherapy planning target volume (PTV), based on the international consensus on assessing local failure after stereotactic ablative radiotherapy (SBRT) will be utilized. The 2-year local control rates will be summarized by treatment arms using 90% Clopper-Pearson confidence intervals. The local control rates between arms will be compared using one-sided Cochrane-Mantel-Haenszel test (alpha=0.1), stratified by performance status, surgery candidacy, and beta-blocker usage.
Measured: Up to 2 years
Secondary outcomes (7)
Progression free survival (PFS)
Will be summarized by treatment arms using the Kaplan-Meier product limit estimator.
Measured: From the start of treatment to first documented disease progression, or death due to any cause, up to 3 years
Overall survival (OS)
Will be summarized by treatment arms using the Kaplan-Meier product limit estimator. One-sided log-rank test stratified by tumor size, performance status, and surgery candidacy will be used to compare the OS between treatment arms (alpha=0.1).
Measured: From the start of treatment to patient death due to any cause, up to 3 years
Time to progression (local control) in a size-dependent manner
Defined as no failure within the radiotherapy PTV, based on the international consensus on assessing local failure after SBRT will be utilized.
Measured: Up to 3 years
PFS for patients who are already taking a beta blocker
Measured: Up to 3 years
Perception of Stress using Perceived Stress Scale
Will be measured by The Perceived Stress Scale (PSS) which assesses the perception of stress. The scale is constituted by 10 items that are self-rated by the subject on a 0-4 Likert scale. The scale minimum total score is 0, the maximum is 40. Higher total scores indicate a worse outcome
Measured: Up to 3 years
Change in Quality of life
Assessed via European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer.
Measured: Up to 3 years
Incidence of grade 3+ adverse events
Toxicities and adverse events (as per Common Terminology for Adverse Events version 5.0) will be summarized by the treatment arms, type, incidence, severity, seriousness, and relatedness. The rate of grade ≥ 3 AEs will be summarized as proportions with 90% Clopper Pearson confidence intervals.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start1 Dec 2026 (estimated)
- Primary completion25 Jun 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Stage Lung Non-Small Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Farrugia, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718672
- Sponsor's protocol ID
- I-4050824
- Other IDs
- NCI-2026-04889, I-4050824
- Status last verified
- Nov 2026
- First submitted
- 14 Jul 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (PRESTO) A Randomized Phase II Trial Evaluating Hotspots in Stereotactic Ablative Radiotherapy for Early-Stage Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07718672
- Acronym / sponsor ID
- I-4050824
- Conditions
- Early Stage Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 25 Jun 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- Evaluate the impact of incorporating high isodoses termed "hot spots" in radiation therapy planning on local control.
SECONDARY OBJECTIVES:
- Evaluate the impact of "hot spots" in radiation therapy planning on progression-free survival (PFS).
II. Evaluate the impact of "hot spots" in radiation therapy planning on overall survival (OS).
III. Evaluate the impact of tumor size on local control and if hotspot grouping impacts local control in a size-dependent manner.
IV. To prospectively evaluate the PFS in early stage-non small cell lung cancer (ES-NSCLC) patients undergoing SABR who are already taking a beta-blocker as well as a potential interaction between beta-blocker usage and the perceived stress scale.
- Will evaluate for any potential interactions between quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer [EORTC QLQ-LC13]) and hotspot grouping.
VI. Evaluate the impact of "hot spots" in radiation therapy planning on toxicity by total number of grade 3+ adverse effects.
EXPLORATORY OBJECTIVE:
- Change in immune cell marker levels at week 12 post-SBRT (± 1 week) versus baseline, such as mediators of tumor antigen presentation, costimulatory molecules, immune effector cell populations, including CD4+ and CD+8 T-cells, T regulatory cells (CD4+CD25+FoxP3+), natural killer (NK) cells, monocytes, macrophages, dendritic cells (DCs) and myeloid derived suppressor cells (MDSCs).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard of care (SOC) SBRT for 1-5 fractions over 1-11 days, in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan with or without positron emission tomography (PET) scan and blood sample collection throughout the study. Patients may undergo lymph node sampling throughout the study.
ARM II: 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.
After completion of study treatment, patients are followed up every 3 months for 1 year and then every 3-6 months up to month 36.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aim II (hot spot SBRT) | Experimental | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Procedure: Lymph Node Biopsy, Procedure: Positron Emission Tomography, Radiation: Stereotactic Body Radiation Therapy, Other: Survey AdministrationPatients 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 | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Procedure: Lymph Node Biopsy, Procedure: Positron Emission Tomography, Radiation: Stereotactic Body Radiation Therapy, Other: Survey AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Aim II (hot spot SBRT), Arm I (SOC SBRT) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT scan | Procedure or surgery | Aim II (hot spot SBRT), Arm I (SOC SBRT) |
| Lymph Node BiopsyAlso: Biopsy of Lymph NodeUndergo lymph node sampling | Procedure or surgery | Aim II (hot spot SBRT), Arm I (SOC SBRT) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)Undergo PET scan | Procedure or surgery | Aim II (hot spot SBRT), Arm I (SOC SBRT) |
| Stereotactic Body Radiation TherapyAlso: SABR, SBRT, Stereotactic Ablative Body Radiation TherapyReceive SOC SBRT | Radiation | Arm I (SOC SBRT) |
| Stereotactic Body Radiation TherapyAlso: SABR, SBRT, Stereotactic Ablative Body Radiation TherapyReceive hot spot SBRT | Radiation | Aim II (hot spot SBRT) |
| Survey AdministrationAncillary studies | Other | Aim II (hot spot SBRT), Arm I (SOC SBRT) |
Primary outcome
Time to progression (local control)
Time frame: Up to 2 years
Defined as no failure within the radiotherapy planning target volume (PTV), based on the international consensus on assessing local failure after stereotactic ablative radiotherapy (SBRT) will be utilized. The 2-year local control rates will be summarized by treatment arms using 90% Clopper-Pearson confidence intervals. The local control rates between arms will be compared using one-sided Cochrane-Mantel-Haenszel test (alpha=0.1), stratified by performance status, surgery candidacy, and beta-blocker usage.
7 secondary outcomes
Progression free survival (PFS)
Time frame: From the start of treatment to first documented disease progression, or death due to any cause, up to 3 years
Overall survival (OS)
Time frame: From the start of treatment to patient death due to any cause, up to 3 years
Time to progression (local control) in a size-dependent manner
Time frame: Up to 3 years
PFS for patients who are already taking a beta blocker
Time frame: Up to 3 years
Perception of Stress using Perceived Stress Scale
Time frame: Up to 3 years
Change in Quality of life
Time frame: Up to 3 years
Incidence of grade 3+ adverse events
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark Farrugia principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biospecimen Collection, Computed Tomography and Lymph Node Biopsy in people with Early Stage Lung Non-Small Cell Carcinoma and Stage I Lung Cancer AJCC v8, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to progression (local control) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.