Bullhead City

This trial investigates the effectiveness of Pumitamig compared to Pembrolizumab in adults with advanced Non-Small Cell Lung Cancer (NSCLC) who have not received prior treatment and whose tumors express PD-L1 at 50% or higher. The study targets individuals with locally advanced or metastatic NSCLC, focusing on those with measurable disease and good performance status. It is a Phase 3 randomized, double-blind study designed to compare these two treatments as first-line options for this patient group. Participants will receive either Pumitamig or Pembrolizumab at specified doses on scheduled days. The treatments are given as monotherapy, meaning each participant receives only one of these drugs throughout the study. The study does not mention additional treatment phases or extensions, focusing on the direct comparison of these two drugs for initial treatment. Throughout the study, researchers will assess how long participants live without their cancer worsening, using standardized criteria over about three years. Overall survival will also be tracked for up to five years. Participants will be monitored regularly to evaluate their response to treatment and overall health. Safety and effectiveness outcomes will be gathered through medical assessments consistent with clinical trial standards for NSCLC.

Researchers are evaluating the effectiveness of trastuzumab deruxtecan (T-DXd) in patients with HER2-positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors in the United States. The study focuses on patients who have already received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options. This observational study aims to capture real-world outcomes in a diverse patient population excluding those with breast, colorectal, non-small cell lung, gastric/gastroesophageal junction cancers, and hematological malignancies. Participants will receive trastuzumab deruxtecan monotherapy as prescribed in routine clinical practice following the FDA label. The study will be conducted across approximately 30 sites including community oncology practices, hospital systems, and academic medical centers, enrolling about 100 patients. Treatment will be observed in a real-world setting without intervention on dosing or administration by the study team. During the study, researchers will collect information on tumor response rates and how long patients respond to treatment, following participants for up to 2.5 years after enrollment. Additional outcomes include time to stopping treatment and time to starting subsequent treatments. Data will be gathered from medical records and clinical assessments to understand the treatment’s impact in everyday clinical use, ensuring thorough safety and effectiveness monitoring throughout the study period.

Researchers are evaluating the effectiveness and safety of an intravenous oncolytic vaccinia virus called Olvi-Vec combined with platinum-doublet chemotherapy and a physician's choice of immune checkpoint inhibitor (ICI) compared to docetaxel in patients with advanced or metastatic non-small-cell lung cancer (NSCLC). This Phase 2, open-label, randomized study targets patients who have experienced first disease progression while on front-line or maintenance ICI therapy following initial platinum-doublet chemotherapy plus ICI treatment. The study focuses on patients with Stage III or IV squamous or nonsquamous NSCLC without known targetable genetic changes in EGFR, ALK, or ROS1. Participants will receive either Olvi-Vec for 3 or 4 days followed by platinum-doublet chemotherapy plus a chosen ICI, or docetaxel according to local practice. The initial cohorts will help determine the Olvi-Vec dose and schedule for the experimental arm. Patients in the docetaxel arm who later show disease progression may cross over to receive the Olvi-Vec combination treatment. The study excludes ICIs other than anti-PD-1 or anti-PD-L1 agents. During the study, participants will undergo regular imaging scans such as CT or MRI to measure tumor lesions and assess progression-free survival up to 12 months after randomization. Researchers will monitor safety, treatment response, and organ function through laboratory tests and physical exams. Women of childbearing potential will have pregnancy tests before treatment. The study also requires participants to adhere to scheduled visits and treatments throughout the course of the trial.

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 evaluating a new device called SelfWrap, a bioabsorbable perivascular wrap, in patients with chronic kidney disease who need a new arteriovenous fistula (AVF) created. The trial aims to assess the safety and effectiveness of SelfWrap in helping the AVF mature without assistance within 180 days and to monitor for any access-related complications within 30 days. This is a multi-center, randomized, single-blind clinical trial involving about 600 participants across up to 30 sites. Participants are randomly assigned to one of two groups: one group will receive the SelfWrap device applied during their AVF creation surgery, which aims to provide mechanical support to improve fistula maturation and durability; the control group will undergo the standard AVF creation surgery without the device. The study follows participants for 36 months to gather long-term data on the outcomes and safety of the device compared to standard care. During the study, participants will attend follow-up visits over three years to assess their fistula maturation status and monitor for any complications. Researchers will evaluate the primary outcomes including unassisted maturation within 6 months and freedom from access-related adverse events within 30 days after surgery. Participants must be willing and able to communicate with the study team and comply with the study schedule to provide ongoing data for safety and effectiveness analysis.

Researchers are evaluating whether a new medicine called PF-08634404 combined with chemotherapy is more effective than the current standard treatment, pembrolizumab with chemotherapy, for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC). This Phase 3 study focuses on adults 18 years and older with squamous or non-squamous NSCLC who are not candidates for surgery or curative chemoradiotherapy and have not received prior treatment for advanced disease. The study excludes participants with known actionable genomic alterations and aims to compare overall survival and progression-free survival over approximately 39 and 32 months, respectively. Participants are assigned to two parts based on their tumor type: squamous NSCLC patients in Part 1 and non-squamous NSCLC patients in Part 2. Within each part, participants are randomly assigned to receive either the experimental treatment PF-08634404 or the control treatment pembrolizumab, each combined with a chemotherapy regimen tailored to tumor type. Treatments are given via intravenous infusions in cycles, followed by maintenance therapy with either monotherapy or combination therapy depending on the study part. Treatment continues as long as it is beneficial and side effects remain manageable. During the study, participants will have regular visits for treatment administration and health evaluations. Cancer response will be monitored with tests every 6 weeks for the first 48 weeks and then every 12 weeks afterward. Researchers will assess overall survival and progression-free survival, ensuring thorough monitoring of participants' health and treatment effects throughout the study period.