Westwood

Researchers are comparing two approaches of standard therapy for patients with stage II to IIIB non-small cell lung cancer (NSCLC) that can be surgically removed. This phase III trial evaluates whether giving chemotherapy and immunotherapy before and after surgery (perioperative) is more effective than giving the same treatments only after surgery (adjuvant). The study aims to find out which method leads to better event-free survival and overall survival over several years. Participants are randomly assigned to one of two groups. In the adjuvant group, patients have surgery first, followed by up to four cycles of platinum-based chemotherapy and up to one year of immune checkpoint inhibitor treatment if there is no disease progression or unacceptable side effects. In the perioperative group, patients receive chemotherapy combined with immune checkpoint inhibitors before surgery, then have surgery, and continue immune checkpoint inhibitor therapy for up to one year afterward. Chemotherapy drugs used may include cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, or vinorelbine, and immunotherapy drugs may include nivolumab, pembrolizumab, or atezolizumab. During the study, patients undergo imaging tests such as CT scans, MRI, or PET/CT scans to monitor their condition. After completing treatment, they are followed for up to 10 years with check-ups every six months. Researchers measure event-free survival at three years, overall survival up to 10 years, surgical outcomes, side effects, and other treatment-related factors to understand which approach offers better results for patients with resectable NSCLC.

Lymphedema is a progressive and incurable condition causing swelling in the upper or lower limbs, affecting millions of people and leading to decreased quality of life and frequent infections. Currently, there are no approved drug treatments, and management relies mainly on compression therapy. This research explores the use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs), commonly used to treat obesity and diabetes, as a potential new treatment for lymphedema, aiming to improve patients' quality of life and clinical outcomes. The study is a prospective, single-arm trial lasting 24 months, involving 110 adults with stage II lymphedema in one limb. Participants will receive GLP-1 RA treatment prescribed by their primary care provider for six months. Follow-up visits will occur at baseline, 3 months, and 6 months after starting treatment. Researchers will monitor changes in limb volume, bioimpedance, body mass index, compression use, and incidence of cellulitis. Participants will complete quality-of-life questionnaires using the Lymphedema Life Impact Scale at multiple time points. Other assessments include limb volume measurements and bioimpedance analysis. Data will be analyzed statistically to evaluate improvements. Safety monitoring and reporting of adverse events will be conducted throughout the study. The total study duration for each participant is six months of treatment with follow-up visits, within the overall 24-month study timeline.

Researchers are evaluating if adding adjuvant chemotherapy (ACT) to ovarian function suppression (OFS) plus endocrine therapy (ET) improves invasive breast cancer-free survival (IBCFS) compared to OFS plus ET alone. This Phase III trial focuses on premenopausal women with early-stage breast cancer that is estrogen receptor (ER)-positive, HER2-negative, and has a 21-gene recurrence score between 16-25 for node-negative patients or 0-25 for patients with 1-3 positive nodes. The study addresses the need for better treatment options for younger women diagnosed with this type of breast cancer, as younger age is linked to worse outcomes despite standard therapies. Participants receive one of two treatments: either OFS combined with an aromatase inhibitor (AI) for five years or adjuvant chemotherapy followed by the same OFS plus AI regimen. The specific AI and GnRH agonist used, along with their dosing schedules, are chosen by the investigator, commonly including goserelin, leuprolide, or triptorelin administered monthly or every three months. Bilateral oophorectomy may be used instead of ovarian suppression if preferred. Endocrine therapy beyond five years is at the investigator's discretion. During the trial, participants will be closely monitored for invasive breast cancer-free survival over an 11-year period from randomization. Assessments include clinical evaluations, hormone receptor testing, tumor staging, and genetic recurrence scoring prior to enrollment. Safety and effectiveness data will be collected throughout the study, with particular attention to treatment side effects and long-term outcomes. The trial involves detailed eligibility screening and ongoing follow-up to ensure accurate measurement of the study's primary outcome.

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 the use of osimertinib alone versus a combination of osimertinib and bevacizumab for treating advanced non-small cell lung cancer (NSCLC) that has spread beyond the lungs and has specific mutations in the EGFR gene. This phase III trial focuses on whether adding bevacizumab, which blocks blood vessel growth to tumors, can better control cancer and improve survival compared to osimertinib alone, a drug that blocks EGFR involved in cancer cell growth. Patients are randomly assigned to receive either osimertinib by mouth once daily or osimertinib with bevacizumab given intravenously every 21 days. Treatment continues unless the cancer progresses or side effects become unacceptable. The study includes imaging tests like CT, MRI, echocardiography, and MUGA scans to monitor disease and heart function, along with blood and urine sample collection. Participants are followed for up to 10 years after treatment ends, with check-ups every 3 months to measure progression-free survival, overall survival, response rates, and side effects. Researchers also analyze blood samples to study how the cancer develops resistance to treatment. This thorough monitoring helps understand long-term effects and how well the treatments control the cancer.

Researchers are evaluating the effectiveness and safety of CARTISTEM4, a product made from human umbilical cord blood-derived mesenchymal stem cells combined with a cross-linked sodium hyaluronate hydrogel. This phase 3 trial compares CARTISTEM4 to a surgical procedure called debridement in adults with knee cartilage lesions and osteoarthritis. The study aims to show whether CARTISTEM4 can better reduce knee pain and improve knee function over two years, and also to explore if it can slow osteoarthritis progression using MRI assessments. Participants will receive either the CARTISTEM4 treatment, which includes a gel made from stem cells and sodium hyaluronate, combined with debridement, or debridement alone to remove unstable cartilage in the knee. CARTISTEM4 is prepared by mixing about 7.5 million stem cells with sodium hyaluronate to form a gel. The treatments will be administered at the start of the study, followed by monitoring over the next two years. Throughout the study, participants will have regular evaluations including pain assessments using the Visual Analog Scale and function evaluations using the WOMAC4 index from treatment start up to 24 months follow-up. Imaging, such as MRI, will be used to assess cartilage and osteoarthritis changes. Participants will also be monitored for safety and ability to follow rehabilitation requirements during the study period.

Researchers are evaluating an experimental drug called REGN7508, a Factor XI monoclonal antibody, to prevent Venous Thromboembolism (VTE) after elective, unilateral total knee replacement surgery in adults. The study is a Phase 3, multicenter, randomized, open-label trial comparing REGN7508 with Apixaban and Enoxaparin, two other blood-thinning medications, as well as a placebo. The goal is to assess how well REGN7508 works to stop VTE and related conditions following knee surgery, along with monitoring possible side effects, drug levels in the blood, and the body's immune response to the drug.

Researchers are evaluating whether adding pembrolizumab, a type of immunotherapy, to usual chemotherapy improves outcomes in patients with stage IIA, IIB, IIIA, or IIIB non-small cell lung cancer that has been removed by surgery. Pembrolizumab may help the immune system attack cancer cells and prevent tumor growth. Chemotherapy drugs like cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel work by stopping tumor cells from growing and spreading. This phase III trial compares disease-free survival between different treatment approaches involving pembrolizumab and chemotherapy. Participants are randomly assigned to one of two treatment groups. In Arm B, patients receive four cycles of chemotherapy followed by pembrolizumab given intravenously every 21 days for up to 17 cycles or every 6 weeks for 16 cycles. In Arm C, patients receive chemotherapy combined with pembrolizumab during the initial four cycles, followed by pembrolizumab alone for up to 13 cycles every 21 days or 12 cycles every 6 weeks. Chemotherapy regimens include various platinum doublets chosen by the treating physician. Arm A was closed as of February 2022. Patients may also undergo tests such as echocardiograms, MRIs, CT scans, and blood sample collections during the trial. Throughout the study, participants are monitored with regular assessments including imaging and blood tests. Follow-up visits occur 6 weeks after treatment, then every 3 months for 2 years, every 6 months for years 2-4, and annually up to 10 years after randomization. Researchers measure disease-free survival, overall survival, adverse events, drug discontinuation rates, and patient quality of life using questionnaires. The study also explores outcomes based on tumor markers like PD-L1 expression and tumor mutational burden.

Researchers are evaluating the safety and effectiveness of the COMS One device in people with hard-to-heal diabetic foot ulcers (DFUs). This is a prospective randomized, double-blinded, sham-controlled trial designed to compare wound closure rates between the COMS One device and a sham device, both used alongside standard care. The main goal is to show that the COMS One device leads to better wound healing over a 24-week period after treatment. The study involves two groups: one using the COMS One device and the other using a sham device. The COMS One device combines optical and magnetic stimulation through red and near-infrared light and pulse-modulated magnetic fields. It is lightweight and portable, applied locally with a single-use sterile component and strap. The sham device looks similar but lacks therapeutic output and specific sensor features to maintain blinding. Treatment is given in addition to standard wound care, and the study includes a screening run-in phase to measure wound closure before randomization. Participants will be monitored for wound healing progress, safety, and other outcomes through scheduled visits over 24 weeks post-application. Wound healing is defined as complete skin closure without drainage confirmed on two visits two weeks apart. Safety assessments and wound parameter evaluations will also be conducted. Around 450 subjects will be screened, with approximately 224 randomized, and follow-up includes assessing wound healing and adverse events during the study.