Sayre

Researchers are evaluating the safety and effectiveness of HLX22 combined with trastuzumab and chemotherapy as the first treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 2, double-blind, randomized, and multiregional study compares this combination against trastuzumab and chemotherapy with or without pembrolizumab. The study aims to measure how well the treatments work in controlling the disease and improving survival for up to five years. Participants will be randomly assigned to one of two groups. One group receives HLX22 at 15 mg/kg every three weeks along with trastuzumab, chemotherapy (XELOX regimen), and possibly a placebo for pembrolizumab. The other group receives a placebo for HLX22 plus trastuzumab, chemotherapy (XELOX), and possibly pembrolizumab every three weeks. Treatment continues until the disease worsens, unacceptable side effects occur, withdrawal of consent, or other protocol-specified reasons. Throughout the study, participants will undergo regular assessments including tumor scans reviewed by an independent committee to evaluate progression-free survival and overall survival over up to five years. Other evaluations include safety monitoring and organ function tests. The study tracks how long patients live without disease progression and overall survival, aiming to better understand the benefits and risks of HLX22 combined with current standard treatments.

Non-small cell lung cancer (NSCLC) is a type of cancer where cells grow uncontrollably in the lung tissues. This study focuses on adults with previously treated non-squamous NSCLC that overexpresses the c-Met protein and have no activating mutations in the EGFR gene. The main goal is to evaluate the safety of an investigational drug called telisotuzumab vedotin and to monitor changes in disease activity and side effects over time. Participants will be randomly assigned to receive one of three different doses of telisotuzumab vedotin through an intravenous (IV) infusion. The study involves approximately 150 adult participants worldwide and lasts for about three years. During this time, participants will receive the treatment at regular intervals as part of the study protocol. Throughout the study, participants will attend regular visits at hospitals or clinics where medical assessments, blood tests, and questionnaires will be used to monitor treatment effects and side effects. Researchers will specifically track adverse events, including lung disease, nerve problems, eye disorders, and any reasons that might lead to stopping the study drug. The main outcomes include safety measures and tumor response evaluated by independent central review over the three-year period.

Researchers are evaluating the safety and effectiveness of Armour Thyroid compared to synthetic T4 treatment in adults with primary hypothyroidism who are currently stable on synthetic T4. The study focuses on assessing how well patients respond to dose conversion from synthetic T4 therapy to Armour Thyroid. This trial is conducted as a Phase 2/3 multicenter, double-blind, randomized, active-controlled study. Participants receive either Armour Thyroid in oral capsule or tablet form or synthetic T4 capsules. They must have been on a stable dose of synthetic T4 for at least 12 months before screening, with a dose of at least 25 mcg daily. The study compares both treatments over time to evaluate efficacy and safety in maintaining thyroid function. During the study, researchers monitor thyroid-stimulating hormone (TSH) levels to measure treatment response at week 55. They also track any adverse events related to the treatments for up to approximately 90 weeks. Participants undergo regular assessments to ensure safety and effectiveness throughout the study period.

Researchers are evaluating the safety and effectiveness of the InnAVasc Arteriovenous Graft (IG) for hemodialysis access in patients with end-stage renal disease (ESRD). The study focuses on patients who require hemodialysis and for whom an arteriovenous graft is the next best option for vascular access. The main goals include measuring the proportion of patients whose graft remains open (secondary patency) at 6 months and monitoring device-related adverse events over the same period. Participants will receive the InnAVasc Arteriovenous Graft implanted in either the forearm or upper arm using standard vascular surgical methods. The graft placement may be a straight "soft C" configuration in the upper arm or a looped configuration in the forearm or upper arm, but it cannot cross the elbow. Patients must be able to take antiplatelet therapy as directed by their doctor. The study includes follow-up visits and assessments for up to 2 years after the graft implant. During the study, participants will undergo regular evaluations including monitoring the graft's function and safety through clinical assessments. Researchers will track adverse events and measure graft patency at 6 months as primary outcomes. Patients will be asked to provide informed consent and will participate in periodic visits and assessments to ensure proper monitoring of their condition and the device's performance throughout the study period.

Researchers are conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease (COPD). Participants must have experienced at least two moderate or one severe COPD exacerbations in the year before joining and be receiving inhaled maintenance therapy. The study focuses on adults who continue to experience symptoms despite current treatments and aims to assess the impact of tezepelumab on COPD exacerbations. Participants will be randomly assigned to receive monthly subcutaneous injections of either one of two doses of tezepelumab or a placebo. Treatment will last for a minimum of 52 weeks and may extend up to 76 weeks. After the treatment period, there will be a 12-week safety follow-up phase to monitor participants after stopping the study drug. The study compares tezepelumab to placebo to determine its efficacy and safety over this extended period. During the study, participants will undergo regular assessments to monitor their COPD status and any exacerbations. The main outcome measured is the annual rate of moderate or severe COPD exacerbations from the start of treatment through up to 76 weeks. Safety and tolerability will also be closely monitored throughout the treatment and follow-up periods. This long-term involvement ensures comprehensive data on how tezepelumab affects COPD progression and exacerbation frequency.

Researchers are evaluating the safety, tolerability, and immune response of a fifth dose of the 6-valent OspA-based Lyme disease vaccine called VLA15 in healthy individuals aged 7 years and older. This Phase 3, randomized, placebo-controlled, double-blinded study aims to understand the effects of an additional vaccine dose on protection against Lyme disease and to monitor for any adverse reactions or new medical conditions. Participants will be randomly assigned in a 5:1 ratio to receive either one dose of VLA15 or a saline placebo injection in the upper arm during the first clinic visit. The study involves about 1712 participants who have previously received four doses of VLA15 and had blood samples taken after the fourth dose. The total study duration is approximately 12 months, during which participants will attend four scheduled clinic visits. Throughout the study, participants will undergo health checks and provide small blood samples. Researchers will monitor for local and systemic reactions within 7 days after vaccination, adverse events up to one month post-vaccination, and any serious adverse events or newly diagnosed chronic medical conditions through the entire study period. Immune responses to the vaccine will be measured one month after the fifth dose. Safety will be overseen by an independent data monitoring committee.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

Researchers are evaluating the effect of adding chemotherapy to immunotherapy (pembrolizumab) compared to using immunotherapy alone in treating older adults aged 70 and above with advanced non-small cell lung cancer (stage IIIB-IV). This phase III trial aims to determine if combining chemotherapy with pembrolizumab improves overall survival and other outcomes like progression-free survival, response rates, toxicity, and quality of life in this vulnerable patient group. Participants are randomly assigned to one of two treatment groups. In the immunotherapy-alone group, patients receive pembrolizumab intravenously every 21 days for four cycles, followed by maintenance pembrolizumab every 21 or 42 days for up to two years if there is no disease progression or unacceptable side effects. In the combination group, patients receive pembrolizumab plus a chemotherapy regimen chosen by their doctor, including drugs such as pemetrexed, carboplatin, nab-paclitaxel, or paclitaxel, given intravenously on specific schedules for four cycles, followed by the same pembrolizumab maintenance. Imaging scans like MRI, CT, and PET are performed at baseline and throughout the study. During the study, participants undergo various assessments including imaging scans, laboratory tests, and questionnaires to evaluate treatment effects, side effects, and quality of life. Researchers monitor overall survival for up to five years from randomization, with follow-up visits every three months for the first two years and every six months thereafter until five years. Additional exploratory analyses include safety, tolerability, and correlations with gut microbiome and geriatric assessments to better understand treatment outcomes in this population.

Researchers are evaluating the Freenome Multiomics Blood Test as a tool to help detect lung cancer earlier in people at high risk. This prospective, multi-center observational study involves participants eligible for standard lung cancer screening using a low-dose computed tomography (LDCT) scan. The study collects blood samples and compares the test's results with routine screening to see how well the blood test detects lung cancer over time. Participants who qualify and consent will have 50 ml of blood drawn for analysis by Freenome or its designee. Blood collection is done within 30 days of consent, and ideally on the same day as the LDCT screening, but up to 45 days after blood collection is allowed for the scan. The study collects detailed clinical and demographic information, including medical history, lifestyle, family history, and exposure risks, along with diagnostic and follow-up imaging and pathology reports related to lung cancer diagnosis. Participants will be followed for at least 24 months from their initial screening CT scan or until early study exit due to withdrawal or death. The researchers will monitor the sensitivity and specificity of the blood test in detecting lung cancer during this period. All clinical data, imaging, lab tests, and outcomes related to lung cancer diagnosis will be carefully recorded and analyzed to evaluate the blood test's performance.