NCT07718672 Hotspot Stereotactic Ablative Radiotherapy Versus Traditional Stereotactic Ablative Radiotherapy for the Treatment of Early-Stage Non-Small Cell Lung Cancer
| NCT ID | NCT07718672 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Roswell Park Cancer Institute |
| Condition | Early Stage Lung Non-Small Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-12-01 |
| Primary Completion | 2029-06-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2026-12-01 with a primary completion date of 2029-06-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Mark Farrugia
PRINCIPAL INVESTIGATOR
Roswell Park Cancer Institute
Frequently Asked Questions
Who can join the NCT07718672 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Early Stage Lung Non-Small Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07718672 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07718672 currently recruiting?
Yes, NCT07718672 is actively recruiting participants. Visit ClinicalTrials.gov or contact Roswell Park Cancer Institute to inquire about joining.
Where is the NCT07718672 trial being conducted?
This trial is being conducted at Buffalo, United States.
Who is sponsoring the NCT07718672 clinical trial?
NCT07718672 is sponsored by Roswell Park Cancer Institute. The principal investigator is Mark Farrugia at Roswell Park Cancer Institute. The trial plans to enroll 200 participants.