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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating bronchoscopic lung volume reduction using thermoablation as a treatment for patients with severe emphysema. This prospective, two-arm, randomized, open-label trial compares this intervention combined with standard conservative therapy against standard therapy alone, following Global Initiative for Chronic Obstructive Lung Disease GOLD guidelines. The study aims to contribute evidence on the benefits and safety of this procedure to provide appropriate care for emphysema patients. The trial involves two groups one receiving bronchoscopic lung volume reduction with thermal ablation using the InterVaporAE System in addition to standard care, and the other receiving only standard conservative therapy. The InterVaporAE System delivers heated water vapor to targeted lung areas, causing tissue remodeling and volume reduction. Participants in the intervention group may receive up to two partial treatments. Participants will be monitored over several months with assessments including patient-reported quality of life, lung function tests like FEV1 and residual volume, vital status checks, 6-minute walk tests, and monitoring for serious adverse events and exacerbations. Follow-up evaluations occur at 3, 9, and 12 months, with the primary outcome measured at 9 months. The study duration and procedures are designed to evaluate the impact and safety of the bronchoscopic treatment compared to standard care.
Actively Recruiting
Researchers are collecting real-world data in Germany to better understand how patients with non-squamous metastatic non-small cell lung cancer NSQ mNSCLC, including certain cases of large cell neuroendocrine carcinoma, respond to a combination of tremelimumab, durvalumab, and platinum-based chemotherapy TDC. The study focuses on the effectiveness of this treatment in relation to specific genetic mutations and protein expressions such as KRAS, STK11, KEAP1, TP53, TTF-1, and PD-L1. This observational study aims to improve knowledge about biomarker-guided treatment strategies for distinct patient subgroups with high medical needs. The study follows patients who are starting first-line treatment with TDC as prescribed by current marketing authorizations. Researchers will observe and record outcomes without altering the treatment plan. The study includes molecular testing such as Next Generation Sequencing for gene mutations and protein expression analyses initiated according to institutional standards. Women who can become pregnant must use effective contraception during and for three months after durvalumab treatment. Participants will be monitored over time for up to two years to assess overall survival rates, treatment responses, progression-free survival, and safety through adverse event collection. Data will be gathered from routine clinical practice visits and medical records. The main measurement is the two-year overall survival rate in the total population and in subgroups with specific gene mutations. This study helps track how well treatments work and their safety in everyday medical settings.