Phase 2 Study of Ipilimumab, Nivolumab, and SBRT for Lung Cancer
This study is for people with resectable (can be removed by surgery) non-small cell lung cancer, stages IB-III. It's testing a combination of treatments given before surgery: ipilimumab and nivolumab (drugs that help your immune system fight cancer) along with low-dose stereotactic body radiation therapy (SBRT), a precise type of radiation. The main goal is to see how well the cancer responds to these treatments before surgery. You can join if you are over 18, have good overall health, and your lungs can tolerate surgery. The study plans to enroll 25 participants and is currently unclear on its recruitment status.
- Study design
- This is a single-arm Phase 2 study, meaning all 25 participants will receive the same treatment combination. It's designed to see how well the treatment works in a specific group of patients.
- What's involved
- You would receive one dose of ipilimumab, three doses of nivolumab, and one or two radiation treatments (SBRT) before surgery. The main outcome is measured approximately 49-63 days after starting treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome is measured between approximately 49 and 63 days after starting study treatment.
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NCT04933903
BrUOG 397: NEO Rad (LOW): Neoadjuvant Low Dose Stereotactic Body Radiotherapy, Ipilimumab and Nivolumab
Recruiting
PHASE2Ages 18+InterventionalTreatmentBrown UniversityInvestigator-initiated
~25 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:IpilimumabNivolumabSBRT
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Patients with a Pathologic Response
Measured over From beginning of study treatment to approximately day 49-63 on study.
Conditions
Where it's being run
1 sites across 1 statesRhode Island1
Study leadership
- Christopher G Azzoli, MD · PRINCIPAL_INVESTIGATOR · Brown University
- Thomas A DiPetrillo, MD · PRINCIPAL_INVESTIGATOR · Brown University
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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. 10. Patients are capable of giving informed consent and/or have an acceptable surrogate capable of giving consent on the subject's behalf. 11. Nonpregnant and non-nursing. The effect of ipilimumab and nivolumab on the fetus is unknown. 12. Women of childbearing potential (WOCBP) must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 5 months after the last dose of study medication. Patients of childbearing potential are those who have not been surgically sterilized or have not been free of menses \>1 year. 13. Evidence of postmenopausal status or negative urinary or serum pregnancy test for female premenopausal patients. Women will be considered postmenopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: 14. Women \<50 years of age would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the postmenopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy). 15. Women ≥50 years of age would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \>1 year ago, had chemotherapy-induced menopause with last menses \>1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy). 16. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. 17. Male patients must agree to use an adequate method of contraception starting with the first dose of study therapy through 7 months after the last dose of study therapy.
Exclusion
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. 10. Patients are capable of giving informed consent and/or have an acceptable surrogate capable of giving consent on the subject's behalf. 11. Nonpregnant and non-nursing. The effect of ipilimumab and nivolumab on the fetus is unknown. 12. Women of childbearing potential (WOCBP) must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 5 months after the last dose of study medication. Patients of childbearing potential are those who have not been surgically sterilized or have not been free of menses \>1 year. 13. Evidence of postmenopausal status or negative urinary or serum pregnancy test for female premenopausal patients. Women will be considered postmenopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: 14. Women \<50 years of age would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the postmenopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy). 15. Women ≥50 years of age would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \>1 year ago, had chemotherapy-induced menopause with last menses \>1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy). 16. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. 17. Male patients must agree to use an adequate method of contraception starting with the first dose of study therapy through 7 months after the last dose of study therapy.
What this trial measures
- Number of Patients with a Pathologic ResponseFrom beginning of study treatment to approximately day 49-63 on study.
Assess Pathologic Response (major pathologic response and complete pathologic response) following neoadjuvant low dose SBRT, Ipilimumab and Nivolumab.