Fano

Researchers are evaluating the safety and effectiveness of the drugs eltrekibart and mirikizumab in adults with moderately to severely active ulcerative colitis UC, a chronic inflammatory bowel disease. This Phase 2 study aims to find out how these treatments work alone or in combination to improve UC symptoms and health. The study is sponsored by Eli Lilly and Company and will last about 4 to 5 years, including screening. Participants will be randomly assigned to receive one of several treatments eltrekibart with a placebo, mirikizumab with a placebo, both drugs together, or placebo alone. The study is double-blinded, meaning neither the participants nor the researchers know which treatment is given to ensure unbiased results. The treatment period includes dosing with the study drugs or placebo, and participants will be monitored for safety and response. Participants will be involved in the trial for around 69 weeks, including a screening period of up to 35 days before starting treatment. Throughout the study, they will undergo assessments to measure clinical remission, response, endoscopic improvement, and quality of life using questionnaires. Blood samples will be taken to study drug levels, and researchers will monitor safety and disease activity regularly. The main outcome is the percentage of participants achieving clinical remission at Week 12, with additional measures assessed up to Week 52.

Researchers are evaluating telisotuzumab adizutecan, alone or combined with osimertinib, compared to standard care in adults with locally advanced or metastatic EGFR-mutated non-squamous non-small cell lung cancer NSCLC. The study aims to assess adverse events and changes in disease activity, enrolling approximately 490 adults worldwide. It includes two phases phase 2 to test doses and combinations, and phase 3 to compare the recommended dose to standard care. During phase 2, participants receive one of two intravenous doses of telisotuzumab adizutecan, either alone or with oral osimertinib. In phase 3, participants receive the recommended phase 3 dose of telisotuzumab adizutecan or standard of care. The entire study lasts about 69 months, with participants undergoing assigned treatments according to their groups. Participants will attend regular visits at approved hospitals or clinics for medical assessments, blood tests, questionnaires, and monitoring of side effects. Researchers will measure objective response and progression-free survival through blinded independent central review over the study duration. Quality of life and lung cancer symptoms will also be evaluated. Safety and overall survival will be tracked throughout the trial.

Researchers are conducting an observational study to assess patient satisfaction, effectiveness, and safety of subcutaneous Atezolizumab treatment in people with certain types of lung cancer and hepatocellular carcinoma. The study focuses on participants treated for approved indications in routine clinical practice across multiple countries and centers. It collects primary data on patient-reported outcomes and clinical effectiveness in real-world settings. Participants receive Atezolizumab as prescribed by their doctors for conditions including early-stage non-small cell lung cancer NSCLC after surgery and chemotherapy, metastatic NSCLC, extensive-stage small cell lung cancer ES-SCLC, and advanced or unresectable hepatocellular carcinoma HCC. Atezolizumab administration is at the physicians discretion and is independent of study participation. The study includes several cohorts based on cancer type and stage. During the study, participants report treatment satisfaction using the Therapy Administration Satisfaction Questionnaire Subcutaneous TASQ-SC at cycles 2 and 3, each lasting 3 weeks. Researchers also evaluate overall survival up to about 3.5 years, quality of life with the EORTC QLQ-C30 questionnaire, and record adverse events during the same period. The study aims to monitor patient experience, clinical outcomes, and safety over the long term, with participation lasting several years.

Researchers are evaluating a mobile health m-health solution designed to support self-management skills in adults with Type 2 Diabetes Mellitus T2DM living in the Marche region of Italy. This randomized clinical trial compares the use of the personalized m-health tool integrated with the Electronic Patient Record EPR against usual diabetes care, focusing on changes in glycated hemoglobin HbA1c levels over an 18-month period. The study aims to enhance patients abilities to manage their condition through technology combined with healthcare collaboration. Participants are randomly assigned to one of two groups the treated group receives regular care plus access to the m-health solution, while the control group continues with standard care alone. The m-health solution includes mobile apps for tracking health data such as blood sugar, lifestyle habits, and diet, receiving alerts and motivational messages, communicating with healthcare professionals, and accessing educational materials. Healthcare providers will monitor patient data through an integrated platform and communicate as needed. The intervention begins at diabetic centers and continues at participants homes. Participants will undergo evaluations at the start and at 6, 12, and 18 months, including clinical assessments, questionnaires, and data collected from the m-health solution. Researchers will assess changes in diabetes severity, medication adherence, lifestyle habits, self-efficacy, quality of life, and the usability and satisfaction with the m-health tool. There are no additional visits or lab tests beyond usual care. The study includes cost-effectiveness analysis and gathers participant feedback to understand their experience with the intervention.

Researchers are evaluating the efficacy and safety of combining gedatolisib and palbociclib with endocrine therapy compared to endocrine therapy and ribociclib in adults with hormone receptor-positive, HER2-negative advanced breast cancer. This Phase 3, open-label, randomized clinical trial involves patients with locally advanced or metastatic breast cancer who have either endocrine-resistant or endocrine-sensitive disease. The study aims to explore treatment options for this specific breast cancer subtype to improve outcomes for patients. Participants are assigned to one of two studies based on their endocrine sensitivity status. Study 1 includes patients with endocrine-resistant cancer who will receive either intravenous gedatolisib combined with oral palbociclib and intramuscular fulvestrant or oral ribociclib with fulvestrant. Study 2 includes endocrine-sensitive patients who will receive intravenous gedatolisib with oral palbociclib and letrozole or oral ribociclib with letrozole. Treatments are administered in cycles with specific dosing schedules, including weekly intravenous infusions and oral medications over 28-day cycles. During the trial, participants will undergo screening to confirm eligibility before randomization. Researchers will monitor progression-free survival for up to 48 months as the primary outcome, along with secondary outcomes such as overall survival, response rates, duration and time to response, clinical benefit, quality of life, and adverse events. Safety follow-up will occur 30 days after treatment, and ongoing assessments will include imaging, tumor biopsies, laboratory tests, and quality of life questionnaires. The study is expected to last several years with continuous monitoring of patient health and treatment effects.

Researchers are evaluating the safety and effectiveness of trastuzumab deruxtecan T-DXd Enhertu4 combined with pembrolizumab compared to platinum-based chemotherapy combined with pembrolizumab for people with locally advanced unresectable or metastatic non-squamous non-small cell lung cancer NSCLC that overexpresses HER2 and has PD-L1 tumor proportion score less than 50%. Participants must not have received prior therapy for this condition and should not have known actionable genomic alterations with locally available treatments. Participants are randomly assigned to one of two treatment groups. One group receives T-DXd intravenously at 5.4 mgkg every three weeks plus pembrolizumab 200 mg IV every three weeks. The other group receives pemetrexed 500 mgm2 IV plus a platinum chemotherapy agent cisplatin 75 mgm2 or carboplatin AUC 5 mgmLmin IV every three weeks along with pembrolizumab 200 mg IV every three weeks. Treatments continue as first-line therapy for advanced or metastatic disease. During the study, participants will have tumor tissue samples assessed for HER2 and PD-L1 expression. Researchers will monitor progression-free survival by imaging review up to about 54 months and overall survival up to about 85 months. The trial is open-label and randomized, with assessments including safety monitoring and efficacy evaluations. Participants are followed throughout treatment and for a long-term period to measure outcomes related to disease progression and survival.

Researchers are evaluating whether a new medicine called PF-08634404, given with chemotherapy, works better than the current standard treatment of pembrolizumab combined with chemotherapy for adults with a type of lung cancer known as non-small cell lung cancer NSCLC. This study focuses on participants with locally advanced or metastatic NSCLC who are not candidates for surgery or curative chemoradiotherapy and have no known actionable genomic alterations. The study is a Phase 3 randomized trial with double-blind masking to compare these treatments. Participants are assigned to one of two parts based on their tumor type those with squamous NSCLC are in Part 1, and those with non-squamous NSCLC are in Part 2. Each participant is randomly placed into one of two treatment groups the experimental group receives PF-08634404 plus chemotherapy, while the control group receives pembrolizumab plus chemotherapy. Treatments are given through intravenous infusions in cycles, followed by maintenance therapy with either PF-08634404 or pembrolizumab, depending on the part of the study. Participants continue treatment as long as it helps and side effects are manageable. During the study, participants attend regular visits for treatment and health assessments. Cancer response is checked every 6 weeks for the first 48 weeks and then every 12 weeks after that. Researchers monitor overall survival, progression-free survival, objective response rates, duration of response, adverse events, lab abnormalities, and quality of life measures. The study includes detailed tracking of drug levels and immune responses. Participation may last up to approximately 39 months, with continuous safety and effectiveness monitoring.

Researchers are studying a new medicine called PF-08634404 to understand how it works when combined with other cancer medicines in people with advanced solid tumors, specifically advanced non-small cell lung cancer NSCLC that has spread and cannot be cured with surgery or standard treatments. This study is an interventional Phase 1B2 trial sponsored by Pfizer, focusing on treatment safety, side effects, and effectiveness. The trial evaluates PF-08634404 combined with different anticancer agents to explore their impact on these advanced cancers. Participants will receive PF-08634404 through intravenous IV infusion along with other cancer medicines. The study is divided into parts Part A tests PF-08634404 with Sigvotatug Vedotin, and Part B evaluates PF-08634404 with another anticancer agent. All treatments and infusions are given at clinical trial sites under medical supervision, with careful monitoring during and after each visit. During the study, participants will undergo assessments to track safety by monitoring adverse events and serious adverse events up to 90 days after the last dose and for up to approximately 5 years. Researchers will measure responses using imaging criteria RECIST v1.1 to evaluate tumor response and disease control. Additional tests include laboratory evaluations, pharmacokinetics to measure drug levels, and monitoring for immune reactions. The study duration spans several years with ongoing safety and efficacy evaluations.