Concurrent or Sequential Immunotherapy and Radiation Therapy in Patients With Metastatic Lung Cancer
Status:
Recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
Trial Design
- 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
approaches.