Search Bar & Filters
Found 7 Actively Recruiting clinical trials
Actively Recruiting
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.
Actively Recruiting
Researchers are evaluating the effectiveness and safety of Datopotamab Deruxtecan (Dato-DXd) with or without durvalumab compared to the investigator's choice chemotherapy combined with pembrolizumab in patients who have PD-L1 positive locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC). This Phase III, randomized, open-label, international study aims to see if adding durvalumab to Dato-DXd can help patients live longer without their cancer worsening or simply live longer compared to standard chemotherapy with pembrolizumab. The study also examines how the treatments and cancer impact patients' quality of life. Participants will be randomly assigned to one of three treatment groups: Dato-DXd plus durvalumab, Dato-DXd alone, or investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin) combined with pembrolizumab. All treatments are given by intravenous infusion. The study design includes stratification based on geographic location, disease-free interval history, and prior PD-1/PD-L1 treatment for early-stage TNBC. During the study, participants will have regular assessments to monitor their disease status using RECIST 1.1 criteria and undergo imaging reviewed by blinded independent central review. Researchers will track progression-free survival, quality of life, safety, and other health measures over an anticipated period of up to 33 months. Participants must provide tumor samples for PD-L1 testing, and safety monitoring will continue throughout the study.
Actively Recruiting
Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.
Actively Recruiting
Researchers are investigating better treatments for people with advanced non-small cell lung cancer (NSCLC) that has specific genetic changes called HER2 mutations. Advanced NSCLC refers to lung cancers that have spread or are unlikely to be controlled with current treatments. HER2 is a protein that helps cells grow, and mutations cause abnormal HER2 leading to cancer growth. This Phase 3 study aims to compare the safety and effectiveness of a new drug, sevabertinib, against standard treatment in patients with this type of lung cancer. Participants will be randomly assigned to receive either sevabertinib tablets twice daily by mouth or standard treatment consisting of cycles of intravenous infusions including drugs like pembrolizumab, cisplatin, carboplatin, and pemetrexed every 21 days. Treatments continue as long as participants benefit without severe side effects or until they or their doctors decide to stop. Participants on standard treatment whose disease worsens may switch to sevabertinib and continue until progression, intolerable side effects, or decision to stop. During the study, participants will undergo imaging scans such as CT, PET, MRI, and X-rays to monitor cancer spread. Health checks include blood and urine tests, heart monitoring with ECG, and pregnancy tests for women. Researchers will ask about participants’ well-being and record any medical problems or side effects experienced. The main outcome measured is progression-free survival over up to about two years.
Actively Recruiting
Researchers are evaluating the effectiveness and safety of osimertinib tablets combined with Datopotamab Deruxtecan (Dato-DXd) intravenous infusion compared to osimertinib alone as a first treatment for people with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has specific EGFR gene mutations (Ex19del and/or L858R). This global Phase III, open-label, randomized study focuses on participants who have not received prior therapy for advanced disease. The goal is to show that the combination therapy improves progression-free survival compared to osimertinib alone. Participants will be randomly assigned to receive either osimertinib 80 mg orally once daily or osimertinib plus Dato-DXd at 6 mg/kg given by intravenous infusion every three weeks. Treatment will continue until the disease progresses, unacceptable side effects occur, or other reasons require stopping. Visits for assessments will occur every three weeks during treatment. For those on osimertinib alone or who discontinued Dato-DXd but continue osimertinib, visits will be every six weeks from cycle 7 to cycle 17, then every 12 weeks until disease progression or treatment stops. Participants receiving both drugs will have visits every three weeks. During the study, participants will undergo regular assessments including scans and laboratory tests to monitor their condition and treatment effects. Researchers will track progression-free survival through independent review about three years after the first participant is enrolled. The study is expected to last about eight years, with ongoing monitoring of safety and treatment tolerance throughout. Participants must attend scheduled visits for evaluations and treatment administration as outlined in the study plan.
Actively Recruiting
Researchers are evaluating the safety, effectiveness, and pharmacokinetics of pumitamig (BNT327) combined with chemotherapy and other investigational agents in adults with first-line non-small cell lung cancer (NSCLC). The study includes two substudies based on NSCLC histological subtypes due to differences in chemotherapy treatments. This Phase 2/3, multisite, randomized, open-label trial aims to assess treatments in participants with advanced NSCLC who have not previously received systemic treatment. Each substudy has a Phase 2 part where participants are randomly assigned to one of two doses of pumitamig combined with chemotherapy drugs such as pembrolizumab, carboplatin, pemetrexed, or paclitaxel, given intravenously. The Phase 3 part will include independent data monitoring and blinded central review of tumor scans for all treated participants. The overall planned duration per participant is up to 64 months, covering both study parts and follow-up. Participants will undergo regular tumor assessments and monitoring for safety, including recording treatment-emergent adverse events, dose changes, and serious side effects up to 90 days after the last dose. Effectiveness will be measured by tumor response rates, changes in tumor size, and progression-free survival, with tumor imaging reviewed by a blinded independent committee. This long-term study involves careful evaluation of treatment impact and participant health over approximately five years.
Actively Recruiting
This research aims to explore the effects of immersive virtual reality-based exercise therapy on patients with Grade 1-2 adhesive capsulitis, also known as frozen shoulder. This condition causes inflammation, fibrosis, and restricted shoulder movement, impacting daily activities and often affecting individuals aged 40 to 60. The study compares immersive virtual reality therapy combined with patient education and home exercises against conventional therapy to assess their impact on pain, functionality, sleep, and cognitive functions. Participants will be randomly assigned to two groups: one receiving patient education, a home exercise program, and immersive virtual reality-based exercises using the Oculus Quest 2 headset with specific applications; the other receiving patient education, a home exercise program, and conventional physiotherapy exercises. Both groups will attend sessions twice a week for six weeks, each lasting 30 minutes, and perform home exercises five days a week on non-intervention days. Patient education will be provided face-to-face before starting treatments. Throughout the study, participants will be evaluated at the beginning and end of the six-week intervention for pain intensity using the Visual Analog Scale, shoulder mobility, daily living activity abilities, sleep quality, and cognitive functions. Researchers will monitor progress with these assessments to compare the effects of the two therapy approaches. The study emphasizes improving motivation, adherence, and functional recovery in patients with adhesive capsulitis.