Pikeville

Researchers are investigating advanced small cell lung cancer SCLC in adults to determine if adding a medicine called obrixtamig to the standard treatment of atezolizumab, carboplatin, and etoposide improves survival compared to the standard treatment alone. Obrixtamig is a molecule designed to help the immune system fight cancer. The study also tests a new medical device that measures levels of the tumour marker DLL3. This is a phase III clinical trial sponsored by Boehringer Ingelheim, using a randomized design to compare treatments. Participants are randomly assigned to one of two groups. One group receives obrixtamig together with the standard treatment, while the other group receives only the standard treatment. All treatments are given through infusions into a vein. Participants receiving obrixtamig will stay overnight at the study site after their first two treatments. The study lasts up to three years, during which tumour size and health status are regularly checked. Throughout the study, participants visit the study site regularly for assessments. Doctors monitor tumour response and check for any side effects or unwanted reactions. The main outcome is overall survival measured up to 36 months. Additional outcomes include progression-free survival, symptom changes, response rates, and monitoring of treatment-related side effects. The study team closely tracks participant health and evaluates quality of life using questionnaires during the first year.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

This research aims to compare progression-free survival in adults with metastatic colorectal cancer harboring the KRAS p.G12C mutation who have not yet received treatment. The study evaluates the effectiveness of combining sotorasib, panitumumab, and FOLFIRI chemotherapy versus FOLFIRI chemotherapy with or without bevacizumab-awwb. This comparison is important for understanding treatment options for this specific cancer mutation. Participants will be randomly assigned to one of two treatment groups. One group will take sotorasib orally every day along with panitumumab and FOLFIRI given by intravenous infusion every two weeks. The other group will receive FOLFIRI chemotherapy every two weeks, with or without bevacizumab-awwb infusion. Treatments will continue as per study protocol to assess their impact on cancer progression. During the study, participants will have their disease monitored using imaging tests based on RECIST v1.1 criteria for up to about three years to measure progression-free survival. Additional outcomes such as overall survival, response rates, duration of response, and adverse events will be tracked for up to five years. The study includes regular medical assessments, laboratory tests, and safety monitoring throughout the treatment and follow-up periods.