RecruitingPhase 2NCT04933903

BrUOG 397: NEO Rad (LOW): Neoadjuvant Low Dose Stereotactic Body Radiotherapy, Ipilimumab and Nivolumab

BrUOG 397: NEO Rad (LOW): Neoadjuvant Low Dose Stereotactic Body Radiotherapy, Ipilimumab and Nivolumab for Patients With Resectable Stage IB - III Non-Small Cell Lung Cancer

Sponsor

Brown University

Enrollment

25 participants

Start Date

Oct 5, 2021

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether giving low-dose radiation (SBRT) combined with two immunotherapy drugs (ipilimumab and nivolumab) before surgery leads to better outcomes for people with early to mid-stage non-small cell lung cancer. **You may be eligible if...** - You have been diagnosed with non-small cell lung cancer (NSCLC) at stage IB through IIIB - Your cancer is considered surgically removable - You are 18 or older and in good health (ECOG 0-1) - Your lung function is adequate to tolerate the planned surgery **You may NOT be eligible if...** - Your lung cancer has spread beyond the chest or is at a more advanced stage - Your lung function is too low for surgery - You have already received chemotherapy or radiation for lung cancer - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIpilimumab

1mg/kg IV on day 1 (1 dose total)

DRUGNivolumab

3mg/kg (to a maximum of 240mg) IV on days 1, 15, 29 (+/- 3 days) (3 doses total)

RADIATIONSBRT

1 fraction or 2 fractions delivered to the gross primary tumor and nodal disease, following the first treatment with ipilimumab + nivolumab on days 1-3.