Tambon Ongkharak

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating the safety and effectiveness of rilvegostomig combined with gemcitabine plus cisplatin compared to durvalumab combined with gemcitabine plus cisplatin as a first-line treatment for patients with advanced biliary tract cancer BTC. This phase III, randomized, open-label study aims to improve treatment options for patients with unresectable locally advanced or metastatic BTC who have not received prior therapy for advanced disease. The study focuses on overall survival and other important outcomes over approximately four years. Participants receive either rilvegostomig or durvalumab through intravenous infusion along with chemotherapy drugs gemcitabine and cisplatin. Durvalumab is given every three weeks for up to eight cycles, then every four weeks. Gemcitabine and cisplatin are administered intravenously on Days 1 and 8 of each 21-day cycle. The study compares these two treatment combinations to assess their effects on survival, disease progression, tumor response, and safety. During the study, participants undergo regular assessments including imaging scans like CT or MRI to measure disease status, laboratory tests to evaluate organ function, and evaluations of symptoms and quality of life. Researchers monitor drug levels and immune response markers. The study lasts about four years, with ongoing safety and health status monitoring throughout. Patient-reported symptoms and quality of life are assessed up to 12 weeks after disease progression.

Researchers are studying the effectiveness of neladalkib NVL-655 compared to alectinib in patients with advanced Non-Small Cell Lung Cancer NSCLC that tests positive for Anaplastic Lymphoma Kinase ALK and who have not received prior treatment. This Phase 3 trial aims to determine if neladalkib can better prolong the time patients live without disease progression. The study involves patients with advanced or metastatic ALK-positive NSCLC and is sponsored by Nuvalent Inc. Participants will be randomly assigned to one of two groups one group will take neladalkib 150 mg orally once daily, and the other will take alectinib 600 mg orally twice daily. Both treatments are given as oral pills, and the study compares these two drugs directly. Patients will be followed for up to 5 years after starting treatment to assess outcomes. During the trial, patients will undergo regular assessments including tumor measurements based on RECIST 1.1 criteria, brain imaging to monitor intracranial progression, and laboratory tests. Researchers will monitor progression-free survival, overall survival, response rates, duration of response, adverse events, and patient-reported quality of life and lung cancer symptoms. The study will last until December 2029, with close follow-up to evaluate long-term effects and safety.

This research is investigating the safety and effectiveness of combining Trastuzumab deruxtecan T-DXd with rilvegostomig, compared to T-DXd alone or the standard chemotherapy regimen of gemcitabine plus cisplatin with durvalumab in patients who have advanced HER2-expressing biliary tract cancer and have not received prior treatment. The study focuses on patients with unresectable, locally advanced, or metastatic biliary tract adenocarcinoma that expresses HER2 protein. Participants are randomly assigned to one of three groups one receiving T-DXd combined with rilvegostomig, another receiving T-DXd alone, and a third group receiving standard chemotherapy with gemcitabine and cisplatin plus durvalumab. All therapies are given by intravenous infusion. The study includes an initial safety run-in phase where participants complete at least one 21-day treatment cycle, followed by a randomized portion that will assess overall survival and other efficacy measures over an estimated period of up to 50 months. During the study, participants will undergo assessments including tumor tissue testing to confirm HER2 expression, evaluations of tumor lesions using RECIST criteria, and monitoring of physical function and adverse effects. Blood samples will be collected to analyze drug levels and immune responses. Researchers will track overall survival, progression-free survival, response rates, and patient-reported tolerability throughout the treatment and up to the studys end. The study duration extends until the final data collection, which may be up to several years after enrollment.