BrUOG 397: NEO Rad (LOW): Neoadjuvant Low Dose Stereotactic Body Radiotherapy, Ipilimumab and Nivolumab
Status:
Recruiting
Trial end date:
2023-01-01
Target enrollment:
Participant gender:
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.