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NCT07718672RecruitingPhase 2

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

(PRESTO) A Randomized Phase II Trial Evaluating Hotspots in Stereotactic Ablative Radiotherapy for Early-Stage Non-Small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 26 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
200 (estimated)
First submitted
14 Jul 2026
Start date
1 Sept 2026
Primary completion date
25 Jun 2029
Lead sponsor
Roswell Park Cancer Institute
Diseases
Lung cancer
NCT number
NCT07718672

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 200
  • From 1 Sept 2026 to the primary completion date, 25 Jun 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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

Other illness

  • Mixed small cell and non-small cell lung cancer
  • History of allogeneic organ transplantation
  • History of primary immunodeficiency
  • 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
  • Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD

Lab values

  • Known EGFR or ALK mutation

Other

  • Pregnant or nursing female participant
  • Unwilling or unable to follow protocol requirements

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Roswell Park Cancer Institute
Coordinator of this site? Confirm its status
BuffaloUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.