OncoMatch/Clinical Trials/NCT04933903
BrUOG 397: NEO Rad (LOW): Neoadjuvant Low Dose Stereotactic Body Radiotherapy, Ipilimumab and Nivolumab
Is NCT04933903 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Ipilimumab and Nivolumab for non small cell lung cancer.
Treatment: Ipilimumab · Nivolumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Small Cell Lung Cancer
Disease stage
Required: Stage IB, IIIA, IIIB (8th Edition American Joint Committee on Cancer (AJCC))
Resectable stage IB-IIIB (T2-3N0, T1-T3N1-2) NSCLC (per the 8th Edition American Joint Committee on Cancer (AJCC) classification) who are candidates for surgery with intent of R0 resection.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiation therapy
Lab requirements
Blood counts
leukocytes ≥2,000/mcL; absolute neutrophil count ≥1,000/mcL; platelets ≥100,000/mcL; Hemoglobin >8.0 g/dL
Kidney function
creatinine within normal institutional limits OR creatinine clearance ≥50 mL/min/1.73 m2 for participants with creatinine levels above institutional normal
Liver function
Total bilirubin within normal institutional limits; AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
Cardiac function
Operability is defined as having adequate pulmonary, cardiac, renal, nutritional, musculoskeletal, neurologic, and cognitive capacity to undergo major pulmonary resection with acceptable morbidity and mortality.
Adequate Organ and marrow function as defined below * leukocytes ≥2,000/mcL, * absolute neutrophil count ≥1,000/mcL, * platelets ≥100,000/mcL, * Hemoglobin >8.0 g/dL * Total bilirubin within normal institutional limits * AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal * creatinine within normal institutional limits OR creatinine clearance ≥50 mL/min/1.73 m2 for participants with creatinine levels above institutional normal. Operability is defined as having adequate pulmonary, cardiac, renal, nutritional, musculoskeletal, neurologic, and cognitive capacity to undergo major pulmonary resection with acceptable morbidity and mortality.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Rhode Island Hospital · Providence, Rhode Island
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