BrUOG 397: NEO Rad (LOW): Neoadjuvant Low Dose Stereotactic Body Radiotherapy, Ipilimumab and Nivolumab
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This single-arm phase 2 study will enroll patients with resectable and operable stage IB - III non-small cell lung cancer and treat them with pre-operative ipilimumab + nivolumab plus low-dose stereotactic body radiation therapy (SBRT) delivered concurrently. Only patients who proceed to surgery will be evaluable for the primary endpoint. The primary efficacy outcome measurement will be pathologic response (including Major Pathologic Response (MPR), and Complete Pathologic Response (CPR)). Secondary outcome measures include safety, and exploratory biomarkers of immune response in pre- and post-operative blood and tissue. A two-stage design will stop the study if fewer than 3 of the first 9 evaluable patients do not achieve MPR. An early stopping rule for safety will stop the study if more than 12 patients are enrolled to find the first 9 evaluable patients.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony nowotwór płuca typu NSCLC
- •Wiek powyżej 18 lat
- •Dobry ogólny stan zdrowia (ECOG 0-1)
- •Wystarczająca funkcja płuc do tolerowania operacji (FEV1 co najmniej 2 litry)
- •Nowotwór w stopniu IB-IIIB, który można całkowicie usunąć operacyjnie
- •Ocenienie przez chirurga płuc przed włączeniem do badania
- •Bez wcześniejszej radioterapii klatki piersiowej
- •Prawidłowe wyniki badań krwi (liczba białych krwinek, płytki, hemoglobina)
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 20, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Rhode Island Hospital
Providence, United States
Trial contact
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/21/2026.
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