Tambl Thaachaang

Researchers are evaluating the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma LA-HNSCC who have not progressed after receiving definitive concurrent chemoradiotherapy cCRT. This phase III, randomized, open-label global study aims to assess whether volrustomig can improve outcomes in this patient population. Participants are randomly assigned to one of two groups those who receive volrustomig as sequential therapy, and those who undergo observation without additional treatment. The study compares these two approaches following prior curative concurrent chemoradiotherapy. The trial includes long-term follow-up to monitor patient outcomes. During the study, participants will be regularly assessed for progression-free survival, overall survival, physical functioning, and quality of life. Researchers will also monitor for the presence of anti-drug antibodies and adverse events related to volrustomig. Follow-up evaluations may continue for up to approximately eight years to fully understand the treatment impact and safety profile.

Researchers are assessing the effectiveness and safety of rilvegostomig combined with fluoropyrimidine and trastuzumab deruxtecan compared to trastuzumab, chemotherapy, and pembrolizumab in adults with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction GEJ adenocarcinoma whose tumors express PD-L1 CPS 1. The study also evaluates rilvegostomig combined with trastuzumab and chemotherapy to understand the contribution of each treatment component. This is a Phase 2, randomized, open-label, global, multicenter trial sponsored by AstraZeneca. Participants are divided into three groups Arm A receives T-DXd, rilvegostomig, and fluoropyrimidine capecitabine or 5-FU Arm B receives pembrolizumab, trastuzumab, and chemotherapy either 5-FU plus cisplatin or capecitabine plus oxaliplatin Arm C receives rilvegostomig, trastuzumab, and chemotherapy 5-FU plus cisplatin or capecitabine plus oxaliplatin. Treatments are given by intravenous infusion every three weeks or oral administration twice daily for capecitabine. This setup allows comparison of different combinations to evaluate each drugs role. During the study, participants will be monitored for progression-free survival and overall survival up to about six years. Researchers will also assess response rates, duration of response, adverse events, pharmacokinetics, immunogenicity, and quality-of-life factors like eating difficulties and side-effect burden. The study involves regular assessments including tumor measurements and laboratory tests. Participation may last several years, with safety and efficacy closely followed throughout this time.

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 efficacy and safety of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease COPD who are receiving inhaled maintenance therapy. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on adults aged 40 to 80 years who have experienced multiple COPD exacerbations in the year prior to enrollment. The trial aims to assess tezepelumabs impact compared to placebo on COPD exacerbations and lung function. Participants will receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo. Treatment duration ranges from a minimum of 52 weeks to a maximum of 76 weeks. Following the treatment period, participants will undergo a 12-week off-treatment safety follow-up to monitor any lasting effects. Throughout the study, participants will be regularly assessed for COPD exacerbations, lung function changes measured by forced expiratory volume FEV1, and quality of life using questionnaires such as the St. Georges Respiratory Questionnaire and COPD Assessment Test. Blood samples will be collected to measure drug levels and immune responses. Safety and efficacy will be closely monitored, with total participation lasting up to approximately 88 weeks including follow-up.

Researchers are evaluating the safety and tolerability of trastuzumab deruxtecan T-DXd combined with immunotherapy agents, with or without chemotherapy, in patients who have HER2 over-expressing non-small cell lung cancer NSCLC. This phase Ib study focuses on advanced or metastatic non-squamous NSCLC patients, aiming to understand optimal dosing and safety profiles. The study is sponsored by AstraZeneca and includes multiple study parts to explore different drug combinations and regimens. The trial includes several parts Part 1 involved dose escalation of T-DXd with durvalumab plus cisplatin, carboplatin, or pemetrexed Parts 3, 4, and 5 assess combinations of T-DXd with volrustomig or rilvegostomig, with or without carboplatin, in various dosing schedules. Patients receive the study drugs as intravenous infusions. Some parts involve randomization between arms with or without carboplatin, focusing on dose optimization in first-line treatment settings. Enrollment in some parts is closed, while others continue to explore safety and efficacy. Participants undergo regular assessments including tumor measurements by RECIST 1.1, organ and bone marrow function tests, and monitoring of adverse events for about 20 months. The study measures safety outcomes like frequency of adverse events and serious adverse events, and secondary outcomes such as response rate, duration of response, disease control, progression-free survival, overall survival, and pharmacokinetics of the drugs. Immunogenicity of the treatments is also evaluated. Participants must have measurable disease and meet performance status criteria, with follow-up to assess treatment effects and safety.

This research aims to evaluate the effects of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with a systolic blood pressure of at least 130 mmHg, and at least one additional risk factor for heart failure. The study is a phase III, randomized, placebo-controlled trial focusing on preventing heart failure events and cardiovascular death. Participants will be randomly assigned to receive either baxdrostat with dapagliflozin or placebo with dapagliflozin. Those starting the baxdrostatdapagliflozin treatment may begin with a lower baxdrostat dose that can be increased if certain criteria are met. A run-in period with dapagliflozin alone for 4 to 6 weeks may occur for those not previously treated or treated less than 4 weeks with SGLT2 inhibitors. Treatment visits will occur at about 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months until study closure. Participants will undergo screening for eligibility within a 14-day period, with an optional pre-screening phase that does not require site visits or consent. During the study, regular assessments including monitoring for heart failure events and cardiovascular outcomes will be conducted. If participants stop the blinded treatment early, they may continue with open-label dapagliflozin unless specific discontinuation criteria apply. The study will continue until a predetermined number of cardiovascular events occur, with ongoing data collection and visits according to protocol.

This research aims to assess the effectiveness and safety of Datopotamab Deruxtecan Dato-DXd combined with rilvegostomig or rilvegostomig alone compared to pembrolizumab alone as initial treatment in participants with locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC that has high PD-L1 expression tumor cells 50% and no actionable genetic alterations. This Phase III, randomized, open-label global study focuses on patients who have not received previous systemic therapy for advanced disease. Participants are randomly assigned to one of three groups one group receives Dato-DXd plus rilvegostomig, another receives rilvegostomig alone, and the third receives pembrolizumab alone. All treatments are given as intravenous infusions every three weeks on the first day of each 21-day cycle. The study evaluates these treatments as first-line therapy for eligible participants. During the study, participants will have regular assessments including tumor evaluations and biomarker testing to monitor disease progression, overall survival, and response rates. Patient-reported symptoms and quality of life will also be measured. The study may last up to approximately six years to capture long-term outcomes. Safety monitoring and pharmacokinetics assessments are included throughout the trial to understand treatment effects and immune responses.

Researchers are studying advanced breast cancer patients who have mutations in BRCA1, BRCA2, or PALB2 genes and whose cancer is hormone receptor-positive and HER2-negative. The study aims to compare the effectiveness of saruparib AZD5305 combined with camizestrant against standard treatments involving CDK46 inhibitors plus endocrine therapy. This is a phase III clinical trial conducted to evaluate treatment options for this specific breast cancer group. Participants will be randomly assigned to one of four treatment groups saruparib plus camizestrant physicians choice of CDK46 inhibitor plus endocrine therapy physicians choice of CDK46 inhibitor plus camizestrant or saruparib plus physicians choice endocrine therapy. Treatments are given orally or by injection according to the group, and continue until the disease progresses, unacceptable side effects occur, or the participant chooses to stop. During the study, participants will undergo assessments to monitor disease progression and treatment effects, including scans and laboratory tests. Researchers will measure progression-free survival and other outcomes such as overall survival, response rates, and quality of life over several years. Safety and tolerability will also be closely observed throughout the study period, which may last up to about 88 months.

Researchers are evaluating the safety and effectiveness of sonesitatug vedotin combined with capecitabine, with or without rilvegostomig, as a first-line treatment for people with Claudin18.2-positive, HER2-negative advanced or metastatic gastric, gastroesophageal junction, and esophageal adenocarcinoma. This Phase III study also assesses the performance of investigational in vitro diagnostics used to identify eligible patients. The trial includes two groups based on PD-L1 status and eligibility for immune checkpoint inhibitor therapy. Participants will be assigned to one of several treatment groups. Cohort 1 includes participants who are PD-L1 positive and eligible for immune checkpoint inhibitors, receiving sonesitatug vedotin, rilvegostomig, and capecitabine. Cohort 2 includes PD-L1 negative or ineligible participants receiving sonesitatug vedotin with capecitabine. Other treatment arms involve combinations including nivolumab, zolbetuximab, and chemotherapy regimens such as CAPOX or FOLFOX. During the study, participants will be monitored for up to approximately five years to assess progression-free survival and overall survival. Researchers will also evaluate response rates, duration of response, pharmacokinetics, immunogenicity, safety, and tolerability. Participants will undergo regular assessments, including imaging to measure tumors and laboratory tests to monitor health and treatment effects.