Fishkill

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are conducting a phase 3, multicenter, randomized, open-label study to compare treatments in patients with metastatic non-small cell lung cancer (NSCLC) who have developed secondary resistance to immune checkpoint inhibitor (ICI) therapy. The study focuses on patients positive for the HLA-A2 phenotype and includes both squamous and non-squamous types of NSCLC. Participants will be grouped based on cancer histology and their performance status to better understand treatment effects. Participants will be randomly assigned in a 2:1 ratio to receive either the experimental treatment OSE2101 or the standard treatment docetaxel. OSE2101 is a cancer vaccine made of nine specific peptide components targeting tumor-associated antigens, combined with an adjuvant to enhance immune response. Docetaxel, the control treatment, is a chemotherapy drug that disrupts cell division. The study uses an assay device to confirm HLA-A2 status before treatment allocation. During the average three-year study period, researchers will monitor overall survival, defined as the time from randomization until death. Patients will be regularly assessed for treatment response and safety. The trial aims to gather important data on the efficacy and tolerability of the OSE2101 vaccine compared to docetaxel in this patient population with metastatic NSCLC and secondary resistance to ICI therapy.