Overland

Researchers are evaluating the use of Tumor Treating Fields TTFields delivered by the NovoTTF-200T device together with pembrolizumab and platinum-based chemotherapy in patients with advanced metastatic non-small cell lung cancer NSCLC. This phase 3 randomized study, called LUNAR-2, aims to assess overall survival and progression-free survival, comparing this combination treatment to pembrolizumab and chemotherapy alone. Secondary goals include analyzing outcomes based on lung cancer subtypes and PD-L1 expression levels. Participants are randomly assigned to one of two groups one group receives TTFields using the portable NovoTTF-200T device along with pembrolizumab and platinum-based chemotherapy, while the other group receives pembrolizumab and chemotherapy without TTFields. The NovoTTF-200T delivers electric fields continuously at 150kHz to disrupt cancer cell division. Treatments are administered concurrently during the study period. Throughout the study, participants will be monitored for survival outcomes up to six years, including overall survival and progression-free survival measured by standard criteria. Researchers will also track response rates, duration of response, disease control rates, and adverse events. Participants will undergo regular evaluations to assess treatment effects and safety, with follow-up continuing for up to six years after treatment begins.

Researchers are evaluating the safety and performance of the Conformal CLAAS device compared to the commercially available WATCHMAN and Amulet left atrial appendage closure devices in patients with non-valvular atrial fibrillation at high risk of stroke. The study aims to establish that the CLAAS device is not worse than these other devices in preventing stroke and related complications. Participants eligible for the study will be randomized to receive either the CLAAS device or one of the comparator devices and will be followed for a total of five years after implantation. Participants will undergo a procedure to implant one of the left atrial appendage closure devices via a catheter-based system. The study includes two groups one receiving the CLAAS device and the other receiving either the WATCHMAN or Amulet device. After implantation, patients will be monitored closely for safety and effectiveness outcomes, including procedure-related complications and stroke prevention over time. The study involves careful follow-up visits and assessments to track device success and any adverse events. Throughout the study, participants will have regular evaluations to monitor outcomes such as procedure complications, death, major bleeding, ischemic stroke, and systemic embolism, with primary outcome assessments at 12 and 18 months and extended follow-up up to five years. Success of the device placement and technical performance will also be assessed at various time points. Participants will be asked to follow medication regimens and attend follow-up visits to ensure proper monitoring. The total duration of participation includes post-procedure monitoring and long-term outcome measurement extending to the end of the study period.