Hot-spot SBRT vs standard SBRT for early-stage NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 study compares two SBRT approaches for early-stage NSCLC: SBRT with hotspot planning versus standard SBRT without hotspot emphasis. Primary goal is to see if hotspot planning improves local tumor control. Secondary goals include effects on progression-free survival, overall survival, toxicity, quality of life, and exploratory immune and biomarker changes. The trial also looks at how tumor size and beta-blocker use may influence outcomes and interactions with patient-reported stress and QoL measures.

Why it matters

Who can join: the full rules

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

Where it's running

• Roswell Park Cancer Institute
  Buffalo, New York, United States Recruiting

Study contacts

• Principal investigator: Mark Farrugia — Roswell Park Cancer Institute

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.