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Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab as first-line treatments for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have high PD-L1 expression. This Phase III, randomized, double-blind, and global study focuses on participants with stage IV mNSCLC who do not have certain genetic mutations or rearrangements and are eligible for systemic therapy. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two biological treatments given as monotherapy. Both groups will be monitored over time to assess treatment impact and safety. Throughout the study, participants undergo evaluations including tumor measurements by CT or MRI, performance status assessments, and organ function tests. Researchers will measure overall survival and progression-free survival for up to approximately five years. Tumor samples are collected before treatment for central testing, and participants’ health and treatment responses are closely followed during the trial period.

Researchers are evaluating how well insulin icodec helps people with type 1 diabetes control their blood sugar levels. This study focuses on participants who have never used insulin icodec before and aims to observe their treatment experience over a period of about 22 to 30 weeks. The study is designed as a real-world, multi-center, prospective observational study to assess glycemic control, treatment satisfaction, and adherence. Participants will be treated with commercially available insulin icodec as prescribed by their doctors, following usual clinical practice. There is no randomization or placebo group; all participants receive insulin icodec. The treatment period lasts approximately 22 to 30 weeks, during which participants continue their daily basal and bolus insulin regimen prior to starting insulin icodec. During the study, participants will have their blood sugar control monitored, including measuring changes in glycated hemoglobin (HbA1c) from baseline to week 26. Researchers will also assess treatment satisfaction and adherence. Participants must provide consent and be available for study visits and data recording throughout the study duration.

Researchers are evaluating a new medicine called Sofetabart Mipitecan (LY4170156) in adults with certain types of ovarian, peritoneal, and fallopian tube cancers. This phase 3 study has two parts: Part A focuses on participants whose cancer no longer responds to platinum-based chemotherapy, while Part B includes those whose cancer still responds to platinum-based treatments. The study aims to compare Sofetabart Mipitecan against current standard treatments and to better understand its safety. Participants receive treatments administered through intravenous (IV) infusions. In Part A, Sofetabart Mipitecan is compared with various chemotherapy drugs or mirvetuximab soravtansine. In Part B, Sofetabart Mipitecan combined with bevacizumab is compared with platinum-based chemotherapy plus bevacizumab. Each participant's time in the study depends on how they respond to the treatment. During the study, researchers monitor participants for progression-free survival, measuring the time from randomization until cancer progression or death, for up to 70 months. Participants undergo assessments including scans to track tumor changes and evaluations of safety and side effects. The study collects tumor tissue samples and monitors participants' health status regularly to understand treatment effects and safety over time.

Researchers are evaluating if combining atezolizumab with standard chemotherapy can improve treatment for patients with sensitive relapse Extensive-stage Small Cell Lung Cancer (ES-SCLC) after progression following first-line treatment. This phase II multicenter study aims to determine whether this combination increases overall survival and to identify any medical problems participants may experience. Sensitive relapse is defined as cancer returning or progressing at least 60 days after completing initial chemo-immunotherapy including PD-L1 inhibitors like atezolizumab or durvalumab. Participants will receive rechallenge chemotherapy consisting of carboplatin plus etoposide at doses chosen by the investigator along with atezolizumab 1200 mg intravenously on day 1 every 3 weeks. This induction phase lasts up to 4 cycles. After that, participants continue with maintenance atezolizumab every 3 weeks for up to 18 cycles or 1 year, unless disease progression, unacceptable toxicity, or other stopping criteria occur. The study treatment period can last up to 15 months. Radiological assessments with CT scans are done at 6 weeks, 12 weeks, and then every 12 weeks to monitor response. Participants attend clinic visits every 3 weeks for treatment and assessments. Researchers continuously monitor for side effects and safety throughout the study. The total study duration is up to 45 months, including about 24 months for enrollment, treatment up to 15 months, and 6 months of survival follow-up. The main outcome measured is overall survival through study completion, averaging 1 year.

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 clinical characteristics and procedural efficacy and safety of different permanent cardiac pacing implantation approaches in patients over 18 years old who need a pacemaker or intracardiac defibrillator. The study focuses on various pacing methods including right chamber endocardial pacing, epicardial pacing, cardiac resynchronization therapy (CRT), conduction system pacing (CSP), and leadless pacing. The study aims to understand how these methods affect patient survival and quality of life, as well as the potential benefits of non-fluoroscopic anatomical and electrophysiological systems during implantation. Participants will receive permanent cardiac pacing devices according to European Society of Cardiology guidelines. The pacing types studied include conventional right ventricular pacing, conduction system pacing (such as His bundle and left bundle branch area pacing), CRT involving biventricular or left ventricular pacing, epicardial pacing, and leadless pacing. The study will observe the safety and effectiveness of these modalities at 30 days, 6 months, and 12 months, considering factors like stable electrical parameters, absence of hospitalizations, and device-related complications. During the study, researchers will collect clinical and procedural data from patients who have undergone device implantation at participating centers over a 10-year period, with an equal follow-up duration. Assessments will include monitoring device function, hospitalizations for heart failure, all-cause mortality, heart failure occurrence, and arrhythmias. Safety evaluations will track procedural complications, infections, and need for re-intervention. This comprehensive data collection aims to improve understanding of pacing methods and their impact on patient outcomes.

Researchers are evaluating a treatment combination for patients with metastatic pulmonary large-cell neuroendocrine carcinoma (LCNEC) who have not received prior therapy. This phase II, prospective multicenter study aims to assess the effectiveness of carboplatin, etoposide, and durvalumab as a first-line treatment for this aggressive lung cancer. The study focuses on patients with advanced disease stages who need new treatment options. Participants receive intravenous carboplatin (dose based on AUC 5 on day 1), etoposide (100 mg/sqm on days 1 to 3), and durvalumab (1500 mg on day 1) every three weeks for up to four cycles during the induction phase. After this, those without disease progression may continue durvalumab maintenance therapy every four weeks for up to 24 additional courses or two years, whichever comes first. Treatment may stop earlier due to disease progression, side effects, or patient choice. Throughout the study, patients undergo regular monitoring, including tumor assessments to measure response according to RECIST criteria. Researchers track blood counts, liver and kidney function, coagulation, and any side effects. The primary outcome is the treatment's efficacy over one year. The study ensures patient safety with ongoing evaluations and follows participants for up to two years or until disease progression or unacceptable toxicity occurs.

Researchers are investigating the effectiveness of adding Atezolizumab to a chemotherapy combination of FOLFOXIRI plus bevacizumab as the first treatment for patients with metastatic colorectal cancer that has proficient mismatch repair (pMMR) and high Immunoscore IC. This phase III, open-label, multicenter trial focuses on patients with initially unresectable and untreated metastatic colorectal cancer. The main goal is to compare how well patients do in terms of progression-free survival over 24 months when treated with these regimens. Participants will be randomly assigned to one of two groups: one group receives FOLFOXIRI plus bevacizumab for up to 8 cycles, followed by maintenance therapy with 5-FU/LV plus bevacizumab; the other group receives the same chemotherapy plus atezolizumab, followed by maintenance including atezolizumab as well. Treatment continues until disease progression, unacceptable side effects, or patient choice. The study accounts for differences in patients' performance status, tumor location, and liver metastases. After the study treatment, further therapies are chosen by the investigators. Throughout the study, patients will undergo regular assessments including scans and laboratory tests to monitor disease status and safety. Researchers will track progression-free survival as the primary outcome over two years. Participants must meet specific health criteria and agree to follow the study procedures over the treatment and monitoring periods. The study aims to better understand the benefits of adding immunotherapy to standard chemotherapy in this patient group.

Researchers are evaluating the safety and effectiveness of mirvetuximab soravtansine combined with bevacizumab as maintenance therapy in adult women with platinum-sensitive ovarian, primary peritoneal, or fallopian tube cancers that have high folate receptor-alpha (FRα) expression. This Phase 3, multicenter, open-label study focuses on patients who have not progressed after second-line platinum-based chemotherapy plus bevacizumab. Participants must have tumors confirmed as FRα-positive using the Ventana FOLR1 assay. Participants will be assigned to receive either mirvetuximab soravtansine at 6.0 mg/kg adjusted ideal body weight plus bevacizumab at 15 mg/kg every 3 weeks, or bevacizumab alone at 15 mg/kg every 3 weeks. Mirvetuximab soravtansine is an investigational antibody drug conjugate designed to selectively kill cancer cells expressing FRα. The treatment is given as maintenance therapy following prior platinum-based chemotherapy and bevacizumab. During the study, participants will undergo regular assessments to monitor progression-free survival for up to 4 years. Researchers will evaluate disease status and safety through clinical evaluations. Participants will also need to adhere to contraceptive requirements during treatment and for several months after. The study aims to understand how well the treatment combination controls cancer without progression and to assess its safety profile over time.

Researchers are conducting the HEROS study, a multicenter observational and prospective research project in Italy, to investigate how HER2 mutations in advanced non-small cell lung cancer (NSCLC) are currently diagnosed and treated in real-world clinical practice. This study partners with the ATLAS project, which gathers data from 59 centers on oncogene alterations in newly diagnosed advanced NSCLC patients. The HEROS study will specifically focus on calculating the prevalence of HER2 mutations and studying approximately 100 HER2-mutated patients for further secondary and exploratory purposes. The study will enroll patients from September 2024 to September 2025, with follow-up lasting 12 months. A subset of 25 centers will also conduct prospective biomarker analysis using blood and tissue samples from primary tumors or metastatic sites, depending on tissue availability. All centers involved in this biomarker analysis are part of the ATLAS project. Patients will be grouped into cohorts based on their HER2 mutation status and tissue sample availability to fulfill the study objectives. Participants will be adults with confirmed advanced or metastatic NSCLC enrolled in the ATLAS project. Researchers will collect and analyze clinical data and biological samples to measure the prevalence of HER2 mutations over one year. The study involves ongoing monitoring and data collection through the ATLAS database and biomarker testing to better understand HER2 mutation incidence and therapeutic management, with the total participation duration including enrollment and 12 months of follow-up.