Actively Recruiting
BrUOG 397: NEO Rad (LOW): Neoadjuvant Low Dose Stereotactic Body Radiotherapy, Ipilimumab and Nivolumab
Led by Brown University · Updated on 2026-03-31
25
Participants Needed
1
Research Sites
256 weeks
Total Duration
On this page
Sponsors
B
Brown University
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
BrUOG 397: NEO Rad (LOW): Neoadjuvant Low Dose Stereotactic Body Radiotherapy, Ipilimumab and Nivolumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed non-small cell lung cancer (NSCLC)
- Age over 18 years
- ECOG Performance Status 0 or 1
- Lung function capable of tolerating surgery: FEV1 at least 2 liters or predicted postoperative FEV1 greater than 0.8 liters or 35% of predicted value; postoperative predicted DLCO at least 35%
- Resectable stage IB to IIIB NSCLC suitable for surgery aiming for complete tumor removal
- Discrete N2 lymph nodes without invasion of surrounding structures; histologic confirmation recommended if suspected
- Evaluation by a thoracic surgeon confirming operability and absence of major comorbidities increasing surgical risk
- No prior thoracic radiation therapy
- Adequate organ and marrow function including leukocytes ≥2,000/mcL, neutrophils ≥1,000/mcL, platelets ≥100,000/mcL, hemoglobin >8.0 g/dL, normal bilirubin, AST/ALT ≤2.5 × institutional limit, creatinine normal or clearance ≥50 mL/min/1.73 m²
- Ability to give informed consent or have an acceptable surrogate
- Not pregnant or nursing
- Women of childbearing potential must use two birth control methods, be surgically sterile, or abstain from heterosexual activity during the study and for 5 months after last dose
- Evidence of postmenopausal status or negative pregnancy test for premenopausal women
- Willing and able to comply with study protocol including treatments and visits
- Male patients must agree to use contraception from first dose until 7 months after last dose
You will not qualify if you...
- Prior history of thoracic radiation
- Inability to tolerate lung surgery due to inadequate pulmonary function or comorbidities
- Evidence of unresectable or advanced disease beyond stage IIIB
- Pregnancy or nursing
- Inability to give informed consent or comply with study requirements
- Women not meeting contraception or menopausal status requirements
- Major health conditions increasing risk of surgery or treatment complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
Research Team
B
BrUOG
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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