Lancaster

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are evaluating the effect of AZD6793, an oral medication, in adults with moderate to very severe chronic obstructive pulmonary disease COPD. This Phase IIb, randomized, double-blind, placebo-controlled study involves approximately 970 participants across about 350 global sites. The trial aims to compare the efficacy and safety of two different doses of AZD6793 against placebo over a 24-week period. Participants will be randomly assigned to one of three groups receiving either dose 1 of AZD6793, dose 2 of AZD6793, or a matching placebo tablet. The study medication is taken orally and the trial lasts for 24 weeks. The study is designed as a parallel-group format with a 111 allocation ratio among the three arms. During the study, participants will be monitored through various assessments including lung function tests measuring forced expiratory volume FEV1, questionnaires evaluating breathlessness, cough, sputum, and quality of life, and tracking of COPD exacerbation events. Blood samples will be collected to measure plasma concentrations of AZD6793. Safety and efficacy outcomes will be evaluated up to 24 weeks, with the main outcome being the rate of moderate or severe COPD exacerbations.

This research aims to better understand outcomes of quitting e-cigarettes in adults who also use cannabis. It focuses on how cannabis and tobacco interact during quitting attempts using varenicline, a medication approved for cigarette cessation but not for e-cigarette cessation. The study targets adults aged 18 to 40 who use both e-cigarettes and cannabis, regardless of their interest in quitting cannabis. The trial is conducted at three sites in South Carolina. Participants receive a 12-week treatment with varenicline following a standard dose schedule starting from 0.5 mg once daily and increasing to 1.0 mg twice daily, maintained for 11 weeks. Alongside medication, participants receive psychosocial counseling and financial incentives each week based on verified abstinence from e-cigarettes using urinary cotinine tests. This approach combines medication, behavioral support, and incentives. During the study, participants will attend weekly visits for assessments including urine tests to confirm tobacco abstinence and cannabis use. Researchers will track changes in cannabis use during the treatment and evaluate the impact of cannabis use severity on quitting success. The main outcome measured is 7-day tobacco abstinence at the end of 12 weeks. The total study duration per participant is 12 weeks, with monitoring throughout this period.

Researchers are evaluating two digital mindfulness-based interventions to improve mental health and well-being in younger breast cancer survivors who have elevated depressive symptoms. This phase III randomized trial focuses on women diagnosed at or before age 50, who completed primary cancer treatments at least six months earlier. The study aims to compare the effectiveness of live instructor-led sessions via Zoom and a self-paced app-based program, exploring which approach best supports psychological health in this population. Participants will be assigned to one of three groups the live online mindfulness sessions MAPs LO conducted weekly for 6 weeks via Zoom, the MAPs App delivering the same content in shorter sessions over 6 weeks, or a meditation-only control group accessing guided audio meditations. Both English and Spanish speakers can participate in the live online and meditation groups, while the app is only available in English. Tablets and internet hotspots are provided if needed. All groups have access to the UCLA MARC mindfulness meditation app throughout the 6-month follow-up. During the study, participants will attend weekly sessions for the live group or engage with app content at home, with usage tracked to measure intervention dose. Researchers will assess depressive symptoms shortly after the intervention and again up to 6 months later, along with fatigue symptoms. They will also investigate factors influencing intervention effects, such as baseline distress and social determinants, and evaluate the cost-effectiveness of the programs. The total study duration includes a 6-week intervention period plus follow-up assessments out to 6 months.

Researchers are evaluating the efficacy, safety, and tolerability of a subcutaneous drug called lunsekimig compared to placebo in adults aged 40 to 80 years who have inadequately controlled Chronic Obstructive Pulmonary Disease COPD with an eosinophilic phenotype. This Phase 2b3 study aims to better understand how lunsekimig might affect COPD symptoms and exacerbations in this specific group. Participants will be randomly assigned to one of three groups lunsekimig dose regimen A, lunsekimig dose regimen B, or a matching placebo. All treatments are given by subcutaneous injection during a 48-week intervention period. The study includes a screening period up to 4 weeks before treatment and an approximately 8-week follow-up after the intervention, for a total duration of up to 60 weeks. During the study, participants will have regular assessments including lung function tests and symptom questionnaires. Researchers will monitor the annual rate of moderate-to-severe COPD exacerbations as the primary outcome. Secondary measures include changes in lung function and quality of life scores, along with safety evaluations such as monitoring adverse events and laboratory tests. Blood samples will be collected to measure drug levels and antibody responses. Participants are observed throughout the treatment and follow-up periods to assess the effects and tolerability of lunsekimig.

This research aims to evaluate whether adding system-level changes to the kidney transplant process can improve how quickly patients start transplant evaluations. The study focuses on addressing barriers in the referral and evaluation steps for patients with end-stage renal disease or kidney disease who are referred for transplantation at five large transplant centers. It is led by Indiana University and involves multiple centers in Georgia, North Carolina, South Carolina, and Indiana. The intervention includes several components transplant centers will receive detailed performance feedback reports on referral and evaluation closures, contact patients using their preferred communication methods, make phone calls to dialysis facilities during patient sessions, and reach out to referring or other healthcare providers if needed. They will also use a secure web-based platform or email to share patient status updates and track all communication efforts before closing referrals. Dialysis centers will participate in an awareness campaign to support these activities. Participants will be involved through their referral to transplant centers, where researchers will monitor the start of transplant evaluations within six months of referral. They will also track changes in waitlisting and transplant receipt over up to one year post-intervention. The study includes ongoing monitoring of referral closures and patient contacts to assess the interventions impact on improving access to kidney transplantation. The total participation period varies depending on referral and evaluation timing.

Researchers are evaluating the efficacy and safety of iptacopan LNP023 in people aged 12 to 60 years with idiopathic immune complex-mediated membranoproliferative glomerulonephritis IC-MPGN. This Phase III, multicenter, randomized, double-blind, placebo-controlled study aims to examine whether iptacopan can reduce protein in the urine and improve kidney function compared to placebo. The study also looks at changes in patient-reported fatigue. IC-MPGN is linked to problems with the alternative complement pathway, which affects disease progression. Participants will receive either iptacopan 200 mg twice daily or a matching placebo, both given alongside standard care. Adolescents receive adjusted doses 2x100 mg b.i.d., while adults receive 200 mg b.i.d. The study includes a double-blind treatment period lasting 18 months. After this period, participants can either stop iptacopan and enter a 30-day safety follow-up or continue iptacopan treatment in an open-label extension study. During the study, participants will undergo regular urine collections to measure protein levels, kidney function tests eGFR, and assessments of fatigue using a patient questionnaire. Researchers will monitor safety through vital signs, ECGs, laboratory tests, and heart function parameters. The total participation lasts up to 18 months with additional safety follow-up or extension treatment options afterward.

Researchers are evaluating the effects of balcinrenone combined with dapagliflozin compared to dapagliflozin alone in patients who have chronic heart failure, impaired kidney function, and have recently experienced a heart failure event. This Phase III study is conducted internationally across about 700 sites and aims to assess how these treatments impact cardiovascular death and heart failure events. Participants will be randomly assigned to one of three groups balcinrenonedapagliflozin 15 mg10 mg plus placebo, balcinrenonedapagliflozin 40 mg10 mg plus placebo, or dapagliflozin 10 mg plus placebo. Each participant will take one capsule and one tablet daily. The study duration averages 22 months, including screening, about 20 months of blinded treatment, and a one-month follow-up with open-label dapagliflozin. During the study, participants will undergo assessments for heart failure events, hospitalizations, and cardiovascular death. Researchers will monitor these outcomes over about 38 months, including symptom scores and other health measures. Safety and treatment effects will be followed during the treatment and the one-month post-treatment period.

Researchers are evaluating whether adding stereotactic body radiation therapy SBRT to the usual treatment improves outcomes for patients with locally advanced, inoperable non-small cell lung cancer NSCLC that has spread to nearby tissues or lymph nodes. This phase III trial compares the effect of SBRT combined with conventional image guided radiation therapy IGRT, chemotherapy, and immunotherapy or targeted therapy against the usual treatment alone. The study aims to assess overall survival, progression-free survival, tumor response, lung function, quality of life, and treatment-related side effects. Participants are randomly assigned to one of two groups. In the first group, patients receive conventional IGRT and chemotherapy with drugs such as paclitaxel, carboplatin, pemetrexed, cisplatin, or etoposide during radiation, followed by immunotherapy with durvalumab or targeted therapy with osimertinib. The second group receives SBRT combined with conventional IGRT and similar chemotherapy, followed by the same immunotherapy or targeted therapy options. Both groups undergo CT andor PETCT scans during follow-up. Chemotherapy schedules vary by drug, including weekly or every 21-day dosing during radiotherapy, with consolidation treatments lasting up to one year. Throughout the study, participants undergo assessments including lung function tests FEV1 and DLCO, quality of life questionnaires, imaging scans, and monitoring for side effects using standard criteria. Follow-up visits occur every three months for the first year, every six months during years two and three, and annually thereafter, continuing for the duration of the study. Biospecimens and advanced imaging data are collected for exploratory analyses, including development of machine learning tools for radiation planning. Overall survival and progression-free survival are the primary outcomes measured up to eight years after randomization.

Researchers are evaluating the addition of BMX-001 to usual symptom management compared to usual symptom management alone to reduce oral mucositis in patients receiving chemoradiation for head and neck cancer. Oral mucositis, which causes inflammation and mouth sores, is a common side effect of chemoradiation that can lead to pain and difficulty swallowing. This phase II trial aims to compare the incidence and duration of severe oral mucositis, as well as other side effects like xerostomia and radiation dermatitis, between the two treatment groups. Participants are randomly assigned to one of two groups. Both receive cisplatin chemotherapy once weekly or every three weeks and undergo image-guided intensity-modulated radiation therapy daily for seven weeks. In addition to usual symptom management, one group receives placebo injections subcutaneously twice a week for eight weeks, while the other group receives BMX-001 injections on the same schedule. Imaging such as CT and MRI scans and optional blood, serum, or plasma collection occur during the study. Throughout the trial, participants complete questionnaires and are monitored for side effects, toxicities, and oral mucositis severity up to 24 months after completing treatment. Follow-up visits occur at 1, 2, 3, 6, 12, and 24 months. Researchers assess patient-reported symptoms, duration of oral mucositis, radiation dermatitis, and overall survival outcomes. The trial also collects biological samples for future research.