Lancaster

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

Researchers are evaluating the effects and safety of AZD6793 tablets in adults aged 40 years and older who have moderate to very severe chronic obstructive pulmonary disease (COPD). This is a Phase IIb, multicenter, randomized, double-blind, placebo-controlled study involving approximately 1160 participants at around 400 sites worldwide. The study aims to compare three different doses of AZD6793 against placebo tablets over 24 weeks to assess how well the treatment works and its safety profile in this population. Participants will be randomly assigned to one of four groups receiving either one of three doses of AZD6793 or a placebo in equal proportions. The treatment involves oral administration of AZD6793 tablets or placebo tablets daily for 24 weeks. The study is designed with parallel groups and includes careful dose-ranging to evaluate different levels of the investigational drug. During the study, participants will be monitored for the annualized rate of moderate or severe COPD exacerbations from baseline up to 24 weeks. Assessments include lung function tests such as pre- and post-bronchodilator FEV1/FVC ratios, symptom questionnaires like the COPD Assessment Test (CAT), and documentation of COPD exacerbation history. Safety will be continually evaluated through clinical assessments and laboratory tests throughout the treatment period.

Researchers are evaluating how adults who use both e-cigarettes and cannabis respond to a tobacco cessation treatment using the medication varenicline and financial incentives. The study focuses on adults aged 18 to 40 who use e-cigarettes regularly and co-use cannabis, aiming to understand how cannabis use affects quitting e-cigarettes. This is a Phase 4 trial conducted at three sites in South Carolina, investigating cessation outcomes and patterns of co-use during treatment. All participants receive varenicline medication for 12 weeks, following a standard dosing schedule starting with a low dose and increasing to 2.0 mg per day. Alongside medication, participants receive psychosocial counseling and financial incentives weekly for verified e-cigarette abstinence confirmed by urine cotinine tests. The study also monitors cannabis use changes and compares cessation success to previous data on cigarette smokers. Participants attend weekly visits for counseling, medication adherence support, and urine testing to confirm abstinence. Researchers measure 7-day e-cigarette abstinence at the end of treatment (week 12) using biochemical verification. The trial also assesses the impact of cannabis use severity on quitting success and tracks patterns of co-use. The total participation duration is 12 weeks, with ongoing monitoring during this period.

Researchers are evaluating the effectiveness, safety, and tolerability of subcutaneous lunsekimig compared to a placebo in adults aged 40 to 80 years with inadequately controlled chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype. This Phase 2b/Phase 3, parallel, 3-arm study focuses on participants who have a history of COPD with an eosinophilic profile and have not achieved control with current treatments. Eligible participants will receive either lunsekimig or a matching placebo through subcutaneous injections over a randomized treatment period of approximately 48 weeks. The study involves three periods: an initial screening period lasting up to 4 weeks, followed by the 48-week treatment period, and finally an 8-week follow-up period. The total study duration may last up to 60 weeks. During the study, participants will be regularly assessed for the annualized rate of moderate-to-severe COPD exacerbations from baseline up to 48 weeks. Researchers will monitor safety, tolerability, and treatment effects through various evaluations throughout the treatment and follow-up periods. Participant involvement includes completing assessments and receiving scheduled injections as part of the study protocol.

Researchers are evaluating the effectiveness and safety of iptacopan (LNP023) in treating idiopathic immune complex mediated membranoproliferative glomerulonephritis (IC-MPGN) in this Phase III multicenter, randomized, double-blind, placebo-controlled study. The study includes adults and adolescents aged 12 to 60 years with confirmed IC-MPGN, aiming to reduce proteinuria, improve kidney function measured by estimated glomerular filtration rate (eGFR), and assess changes in patient-reported fatigue. The underlying mechanism involves dysregulation of the alternative complement pathway believed to drive the disease's progression. Participants will be assigned to receive either iptacopan 200 mg twice daily or a matching placebo, both alongside their standard care. Adolescents receive two 100 mg doses twice daily. The treatment period is double-blind and lasts 6 months, followed by an 18-month assessment. After completing the study treatment, participants may either stop iptacopan and enter a 30-day safety follow-up or continue treatment in an open-label extension study for longer-term evaluation. During the study, participants will undergo urine collections, kidney function tests, and patient questionnaires to monitor proteinuria levels, kidney function, and fatigue. The primary outcome is the change in urine protein-to-creatinine ratio from baseline at 6 and 18 months. Safety and efficacy will be closely monitored throughout the study and follow-up periods to assess the impact of iptacopan compared to placebo.

Researchers are evaluating the effect of balcinrenone/dapagliflozin compared with dapagliflozin alone on cardiovascular death and heart failure events in patients with chronic heart failure and impaired kidney function who recently experienced a heart failure event. This is a Phase III, international, randomized, double-blind, parallel-group, active-controlled study involving approximately 700 sites in about 40 countries. Participants will be randomly assigned in a 1:1:1 ratio to receive one of three treatments once daily: a capsule of balcinrenone/dapagliflozin 15 mg/10 mg with a placebo tablet, a capsule of balcinrenone/dapagliflozin 40 mg/10 mg with a placebo tablet, or a dapagliflozin 10 mg tablet with a placebo capsule. The study is event-driven, with an estimated average duration of 22 months that includes a screening period, a 20-month blinded treatment phase, and a one-month follow-up on open-label dapagliflozin. During the study, participants will be monitored for the time to first occurrence of cardiovascular death, heart failure hospitalization, or heart failure events without hospitalization over approximately 38 months. Assessments include clinical evaluations, laboratory tests, and safety monitoring throughout the study and follow-up period to track treatment effects and patient outcomes.

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 that has spread to nearby tissues or lymph nodes. This phase III trial compares SBRT combined with conventional image guided radiation therapy (IGRT), chemotherapy, and immunotherapy or targeted therapy versus the usual treatment alone. The usual chemotherapy involves drugs like cisplatin, carboplatin, paclitaxel, nab-paclitaxel, pemetrexed, and etoposide. Immunotherapy with durvalumab or targeted therapy with osimertinib is also given after chemotherapy, aiming to interfere with tumor growth and spread. Patients are randomly assigned to one of two treatment groups. In the control group, patients receive conventional IGRT with weekly or every-3-week chemotherapy followed by immunotherapy with durvalumab or targeted therapy with osimertinib. In the experimental group, patients receive SBRT to the primary tumor plus conventional IGRT to nodal metastases, combined with the same chemotherapy and consolidation therapies as the control group. Radiation therapies are delivered with precision to minimize damage to healthy tissue. Follow-up imaging with CT and/or PET/CT scans are performed during and after treatment. Participants undergo physical exams, imaging scans, pulmonary function tests, and quality of life assessments before, during, and after treatment. Researchers monitor overall survival and progression-free survival for up to eight years. They also track tumor response, local control, treatment side effects, lung function changes, and patient-reported outcomes. Follow-up visits occur every three months for one year, every six months for years two and three, and yearly thereafter to assess long-term effects and safety.

Researchers are evaluating the addition of BMX-001, a drug that neutralizes harmful substances and reduces tissue damage, to the usual symptom management for patients receiving chemoradiation for head and neck cancer. This phase II trial aims to compare the incidence and duration of severe oral mucositis, a painful inflammation and sores in the mouth, between patients treated with BMX-001 and those receiving a placebo. The study also assesses other side effects like dry mouth and skin reactions, overall survival, progression-free survival, pain reduction, and collects blood samples for future research. Participants are randomly assigned to one of two groups. Both groups receive standard cisplatin chemotherapy either weekly or every three weeks and undergo image-guided intensity-modulated radiation therapy daily for seven weeks. One group receives BMX-001 injections under the skin starting before radiation and cisplatin, continuing twice weekly for eight weeks, while the other group receives placebo injections on the same schedule. Patients may have CT or MRI scans during the study and can optionally provide blood, serum, and plasma samples. During the study, patients are monitored from the start of radiation through four weeks after treatment to track severe oral mucositis and other side effects. Additional assessments occur at 6, 8, and 12 weeks post-treatment. Follow-up visits continue at 1, 2, 3, 6, 12, and 24 months to observe long-term outcomes. Researchers use questionnaires, clinical evaluations, and lab tests to measure symptoms, toxicity, and treatment effects throughout the study.