Pesaro

Researchers are conducting a Phase 3 study to compare two front-line treatments for adults with nonsquamous non-small cell lung cancer (NSCLC) that is stage IV or advanced stage IIIB/C. The study focuses on patients whose tumors have a KRAS p.G12C mutation and are negative for PD-L1 expression. The main goal is to evaluate how each treatment affects progression-free survival and overall survival over about 2.5 years. Participants will be randomly assigned to receive either sotorasib combined with platinum doublet chemotherapy or pembrolizumab combined with platinum doublet chemotherapy. Sotorasib is given orally, while pembrolizumab is given intravenously. Both groups will receive the combination therapies as their initial treatment for advanced NSCLC. During the study, participants will be monitored regularly to assess treatment effects and safety. Researchers will track how long patients live without the cancer worsening and overall survival over approximately 2.5 years. The study includes evaluations to determine eligibility and ongoing assessments to monitor health and treatment response throughout the trial period.

Researchers are evaluating the combination of bleximenib, venetoclax (VEN), and azacitidine (AZA) compared to placebo with venetoclax and azacitidine alone in treating adults newly diagnosed with acute myeloid leukemia (AML) who have specific gene mutations (NPM1 or KMT2A) and are not eligible for intensive chemotherapy. This is a phase 3 randomized, double-blind, placebo-controlled study focusing on participants with AML harboring these genetic abnormalities. The study aims to assess treatment effectiveness by measuring complete remission rates and overall survival. Bleximenib and venetoclax are given orally, while azacitidine is administered either intravenously or under the skin. Participants will receive either the combination of bleximenib, venetoclax, and azacitidine or placebo with venetoclax and azacitidine, following a rigorous treatment schedule. The study includes an initial treatment period where the effects of these drugs are compared to determine their impact on AML with the given mutations. Participants will be closely monitored through regular assessments, including evaluations of remission status and survival over a period of up to 4 years and 1 month. Safety and treatment responses will be tracked throughout the study. Participants must consent to follow the study procedures and agree to contraception requirements during and after treatment. The trial involves continuous observation to gather comprehensive data on treatment outcomes and participant health.

Researchers are evaluating autologous tumor infiltrating lymphocytes (TIL) therapy called LN-145 in patients with metastatic non-small-cell lung cancer (NSCLC) without certain genetic mutations. This phase 2, open-label, multi-cohort, non-randomized, multicenter study aims to assess the treatment's effects in patients who have progressed after first-line therapies including immunotherapy and chemotherapy. LN-145 uses a special process to grow a patient's own immune cells to target cancer. The treatment involves removing a tumor sample from each patient, then growing the tumor infiltrating lymphocytes outside the body. Patients receive chemotherapy to reduce their immune cells before being given an infusion of their own expanded TIL cells (LN-145), followed by injections of IL-2 to support the immune response. The study includes patients with at least one resectable tumor for cell preparation and measurable tumors for evaluation. Participants will be monitored for tumor response and safety for up to 60 months. Assessments include imaging scans to measure tumor size and organ function tests. Researchers will track how well patients respond to the treatment and watch for side effects. Follow-up includes regular check-ups and evaluations over several years to understand the long-term effects of LN-145 therapy.

Researchers are evaluating patients who have experienced athero-thrombotic events such as coronary artery disease, cerebrovascular disease, or peripheral artery disease. The study aims to assess how well patients follow guideline recommendations, particularly focusing on improving cholesterol levels and other modifiable risk factors to reduce the chance of cardiovascular event recurrence. This observational and prospective study takes place across multiple cardiology centers in Italy to represent a broad patient population. The study includes several phases starting with an educational intervention to discuss guideline recommendations for secondary prevention. Following this, data is collected for three months or until 30 patients with documented cardiovascular conditions are enrolled, using a web-based case record form that identifies when guidelines are not followed and records reasons for non-adherence. After six months, primary and secondary outcomes are evaluated. A second educational intervention then shares findings from the first phase to highlight gaps in clinical practice, followed by another three-month data collection period and a further six-month outcome assessment. Finally, all patients are followed for 12 months to monitor longer-term results. Participants provide informed consent and are monitored through data collection forms that track adherence to guidelines and clinical outcomes. The main outcome measured is adherence to cholesterol management guidelines over six months. Additional assessments include adherence to recommendations for other cardiovascular risk factors. Throughout the study, researchers gather data to understand how guideline adherence affects patient health and to identify barriers to following best practices, with continuous follow-up over a year to evaluate sustained effects.

Researchers are conducting a Phase 3, randomized, double-blind, multiregional study to compare two treatments for metastatic non-small cell lung cancer (NSCLC). The study includes two separate groups based on NSCLC histology: squamous and non-squamous types. The main goals are to evaluate overall survival and progression-free survival, with additional focus on treatment response and safety. Participants are randomly assigned to receive either ivonescimab combined with platinum-doublet chemotherapy or pembrolizumab combined with platinum-doublet chemotherapy. Both treatments are given as intravenous injections. Each histology group will be analyzed separately, with about 600 patients in the squamous group and 1000 in the non-squamous group. During the study, participants will be monitored for survival outcomes over approximately 3 to 4 years. Researchers will assess tumor response and safety through regular evaluations. Eligibility requires confirmed metastatic NSCLC, with specific tumor measurements and no prior systemic treatment for metastatic disease. This study aims to provide important information on these first-line treatment options for metastatic NSCLC.

Researchers are evaluating the impact of a mobile health (m-health) solution on improving the self-management skills of adults with Type 2 Diabetes Mellitus (T2DM) living in the Marche region of Italy. This randomized clinical trial compares the personalized m-health solution, integrated with patients' Electronic Patient Records (EPR), to usual care. The main goal is to assess changes in glycated haemoglobin (HbA1c) levels from the start of the intervention through 18 months, along with other health-related factors like medication adherence, lifestyle habits, self-efficacy, and quality of life. Participants in the treated group will receive training and personalized setup of the m-health solution, which includes mobile applications for tracking health data, receiving alerts and motivational messages, communicating with healthcare professionals, and accessing educational materials. Healthcare providers at Diabetes Centres (CADs) will monitor patient data via a dedicated EPR interface and maintain communication as needed. The intervention begins at the CADs and continues at participants' homes, with follow-up evaluations at 6, 12, and 18 months. Throughout the study, participants will complete self-administered questionnaires and clinical assessments during routine physician visits. Data will be collected from the m-health solution, clinical evaluations, and focus groups to evaluate usability, patient experience, and cost-effectiveness. Importantly, no extra visits or laboratory tests beyond usual care are required. The total observation period spans 18 months from baseline to final follow-up.

Researchers are evaluating a program called EuroHeart, developed by the European Society of Cardiology (ESC), which aims to improve care for patients with common heart conditions like Acute Coronary Syndrome (ACS), heart failure, and atrial fibrillation. This observational, prospective, multicenter initiative collects standardized patient data continuously in real-world clinical settings to support ongoing quality improvement. The focus is on how well healthcare providers follow ESC quality indicators proven to improve patient outcomes, addressing gaps between research and everyday practice. The study specifically looks at the Italian implementation of EuroHeart, monitoring adherence to ESC quality indicators in clinical care. It does not involve experimental treatments but collects detailed data on the management of patients hospitalized with ACS, heart failure, or atrial fibrillation. Participants' care is tracked throughout their hospital stay and beyond, with no additional interventions imposed by the study. Participants will be followed for 12 months after enrollment. During this period, researchers will collect data on clinical events, treatment adherence, and patient status to evaluate how well ESC quality indicators are met, such as timely reperfusion for STEMI patients and appropriate medication prescriptions at discharge. This long-term follow-up supports efforts to enhance care quality and patient outcomes in cardiovascular diseases.

Researchers are evaluating treatment options for patients with advanced or metastatic pancreatic adenocarcinoma who have not experienced disease progression after 3 months of induction chemotherapy with mFOLFIRINOX. This phase III, randomized, open-label trial compares switch maintenance therapy using gemcitabine plus nab-paclitaxel against continued treatment with modified FOLFIRINOX. The study aims to determine which approach better supports overall survival in this patient population. The initial induction treatment consists of mFOLFIRINOX given every two weeks for up to 14 weeks (approximately 6 cycles). Patients showing complete or partial response, stable disease, or no progression after at least 4 cycles are randomized 1:1 to either continue modified FOLFIRINOX or switch to gemcitabine plus nab-paclitaxel. The switch maintenance therapy is administered on days 1, 8, and 15 of 28-day cycles. Stratification during randomization considers performance status and disease extent. Participants will undergo radiological tumor assessments before and after induction chemotherapy. Throughout the study, researchers will monitor overall survival up to 48 months from randomization. Safety and treatment effects are assessed regularly, and patients must meet specific health and laboratory criteria to participate. The study involves comprehensive monitoring to evaluate treatment impact and patient status during and after therapy.

Researchers are evaluating the addition of gemtuzumab ozogamicin to standard chemotherapy to reduce minimal residual disease (MRD) levels in adults aged 18 to 60 with favorable or intermediate-risk acute myeloid leukemia (AML) who have not been previously treated. This phase 3 study focuses on patients with de novo AML, excluding certain subtypes and mutations, to see if MRD-driven post-remission therapy, such as autologous or allogeneic stem cell transplant, improves anti-leukemic outcomes. Participants will receive induction and consolidation chemotherapy combining gemtuzumab ozogamicin with daunorubicin and cytarabine. The treatment aims to lower MRD before transplant and guide risk assignment for subsequent therapy intensity. The study is conducted at multiple centers and targets patients with specific AML risk profiles, excluding those with prior chemotherapy (except limited hydroxyurea use) or radiotherapy. During the study, patients will be closely monitored for MRD levels, along with assessments of organ function and overall health status. Primary outcomes include achieving MRD negativity within two months. Safety evaluations and follow-up will track treatment effects, adherence, and patient response. The study duration and detailed follow-up schedules are determined by the protocol to ensure comprehensive evaluation of treatment impact.

Researchers are collecting epidemiological data on adults newly diagnosed with myelodysplastic syndrome (MDS) to better understand the disease. The study aims to develop a network of Italian regional registries that use a unified electronic case report form to store patient data. This network will allow for the aggregation and analysis of anonymous data from different regions and enable combining this information with other international registries. There are no specific treatments or interventions in this study as it focuses on data collection and registry development. The main goal is to gather consistent and comprehensive epidemiological data through regional registries across Italy. Participants will have their diagnosis and related information recorded in the registry. Researchers will monitor outcomes over six years, including the incidence and prevalence of MDS, overall response rates, survival rates, progression-free survival, and progression to acute myeloid leukemia (AML). The study involves long-term follow-up to track these outcomes and improve understanding of MDS epidemiology.