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NCT03223155
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.
NCT04056247
The PROPHETIC study is a prospective, multi-center, international clinical study aimed at developing an algorithm to predict patient outcomes. The study involves analyzing the proteomic profiles of patients undergoing therapy to assess the likelihood of clinical benefit from their prescribed treatment. Blood samples are collected prior to and during the treatment period and analyzed as part of the ongoing development of thealgorithm.