Patients with stage IV non-small cell lung cancer are randomized to nivolumab/ipilimumab
plus either sequential or concurrent stereotactic body radiotherapy (SBRT).
The primary endpoint is the phase I safety endpoint of SBRT dose for each body site.
The same starting SBRT dose levels are used in each arm. If two or more patients
experience a dose-limiting toxicity (DLT) at the starting dose level, then the reduced
dose level will be used (Section 7.1-Page 72).
DLT is defined as any grade ≥3 toxicity possibly, likely, or definitely related to SBRT
plus nivolumab/ipilimumab (the combination and not the individual components).
Irradiated metastases will be grouped into one of five locations, which have different
SBRT doses, and the DLTs will be attributed to the relevant organ system.
The starting and decreased SBRT dose levels are found in Table 2 (Page 20).
SBRT will be delivered in 3-5 fractions over the course of 1-1.5 weeks.
Patients in the sequential arm will begin immunotherapy between 1-7 days after
completion of SBRT
Given the accrual data for IRB15-1130, the investigators anticipate that approximately
1/3 of patients will contribute metastasis to 2 locations. Since there are 2 arms, and 5
metastasis locations with 6 patients per location for the starting dose level, this
translates to 40 patients for the starting dose level, and another 40 patients should
each of the 5 locations require de-escalation to the lower dose level.
Secondary endpoints include comparisons of efficacy and toxicity between the arms, as
well as interrogation of changes in the immune microenvironment induced by the two
Stage IV Small Cell Lung Cancer
stereotactic body radiation therapy
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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