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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are investigating treatment options for patients with advanced non-small cell lung cancer (NSCLC), a condition where current outcomes remain poor. This pilot study aims to evaluate the safety and feasibility of adding stereotactic ablative radiotherapy (SABR) to the lung primary tumor before starting standard systemic therapy. The study will focus on patients with stage IV NSCLC who have not yet received systemic therapy, testing whether radiotherapy can be safely delivered and assessing its impact on treatment outcomes. Participants will be randomly assigned to one of two groups: one receiving standard of care (SoC) systemic therapy alone, and the other receiving radiotherapy to the lung primary before the third cycle of systemic therapy. Radiotherapy doses vary depending on tumor location and size, with specific regimens for central, ultracentral, large, and peripheral tumors. Standard systemic therapy includes chemoimmunotherapy combinations such as Pembrolizumab with Carboplatin or Paclitaxel for squamous NSCLC, and Pembrolizumab with Carboplatin or Pemetrexed for non-squamous NSCLC, administered in cycles every three weeks. Throughout the study, participants will undergo regular assessments including radiation toxicity monitoring, adverse event tracking, and CT scans every six weeks to evaluate disease progression. Study visits occur at baseline, radiotherapy (for the radiotherapy group), cycle 3 of systemic therapy, and at 12 and 24 weeks post-treatment initiation. Biospecimens will also be collected for future research. The primary goal is to determine if the study design can proceed to a larger phase III trial without major modifications, with an overall recruitment and follow-up period of 18 months.
Actively Recruiting
Researchers are evaluating a range of treatments to improve outcomes for adults admitted to intensive care units (ICUs) with severe community-acquired pneumonia (CAP), including cases caused by influenza and COVID-19. This Phase 3 adaptive platform trial, REMAP-CAP, is designed to test multiple treatment strategies simultaneously and adapt over time, allowing new treatments to be added as questions are answered. The trial also serves as a platform to quickly evaluate treatments during respiratory pandemics, such as COVID-19, through a sub-study called REMAP-COVID in the United States. Participants receive various interventions including antibiotics like ceftriaxone, moxifloxacin, or piperacillin-tazobactam, as well as macrolide therapies given for different durations. Other treatments assessed include corticosteroids such as hydrocortisone and dexamethasone, antiviral agents like oseltamivir and remdesivir, immune modulators including tocilizumab and baricitinib, and supportive care strategies such as mechanical ventilation methods. Dosing and duration vary for each treatment, with some interventions now closed. Treatments are administered according to local guidelines and clinical decisions, with some requiring intravenous or enteral routes. Participants are closely monitored with assessments focusing on survival and organ support status in the ICU up to 90 days after enrollment. The main outcomes measured include all-cause mortality by day 90 and the number of days alive without needing organ support in the ICU by day 21. The study collects data continuously to adapt treatment assignments for new participants, aiming to identify the most effective therapies. Follow-up and safety monitoring continue throughout hospitalization and up to 90 days after admission.