Testing the Addition of an Antibody to Standard Chemoradiation Followed by the Antibody for One...
Recurrent Lung Non-Small Cell CarcinomaStage III Lung Cancer AJCC v84 moreThis phase III trial studies how well an antibody (durvalumab) with chemotherapy and radiation therapy (chemoradiation) works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This study is being done to see if adding durvalumab to standard chemoradiation followed by additional durvalumab can extend patients life and/or prevent the tumor from coming back compared to the usual approach of chemoradiation alone followed by durvalumab.
A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients...
AsthmaThis is a phase 1, first-in-human (FIH), multi-center, randomized, double-blind, placebo-controlled study of CSL311 in patients with mild-to-moderate asthma. The primary objective of this study is to assess the safety and tolerability of single ascending doses (SAD) and multiple ascending doses (MAD) of CSL311.
Home Airway Clearance in CF Patients
Pulmonary Cystic FibrosisRegular bronchial clearance is essential in patients with cystic fibrosis for their bronchial health. SIMEOX® (Physio-Assist, Aix en Provence, France) is an innovative medical device for the drainage of the bronchial tree. By changing the rheological properties of mucus, SIMEOX® helps to mobilize secretions and assists their transport to the upper airways. This technology is based on fundamental research on bronchial mucus rheology. At the present time, SIMEOX® device is mainly used over a short period at the time or after an exacerbation in healthcare structures (hospitals, physiotherapy practices, post-care, and rehabilitation units, etc…). The clinical effects observed in the short term encourages long-term autonomous use by the patients themselves. The overall objective of this study is to evaluate the efficiency and acceptability of SIMEOX® used at home by the patient himself for bronchial clearance in patients with cystic fibrosis.
A Study of CPI-0209 in Patients With Advanced Solid Tumors and Lymphomas
Advanced Solid TumorDiffuse Large B Cell Lymphoma6 moreFirst-in-human, open-label, sequential dose escalation and expansion study of CPI-0209 in patients with advanced solid tumors and lymphomas. CPI-0209 is a small molecule inhibitor of EZH2.
Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced...
Non-Small Cell Lung CancerAdvanced Solid Tumors2 moreCancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given to adult participants to treat advanced solid tumors. ABBV-400 is an investigational drug being developed for the treatment of advanced solid tumors. Study doctors put the participants in groups called treatment arms. The Recommended Phase 2 dose (RP2D) will be explored. Each treatment arm receives a different dose of ABBV-400. This study will include a dose escalation phase to determine the best dose of ABBV-400, followed by a dose expansion phase to confirm the dose. Approximately 460 adult participants with NSCLC, gastroesophageal adenocarcinoma/gastroesophagel junction adenocarcinoma (GEA) and colorectal cancer (CRC) or advanced solid tumors, will be enrolled in the study in approximately 7-10 sites in the Dose Escalation phase and 85-95 sites in the Dose Expansion phase worldwide. In the dose expansion arms, participants in the following advanced solid tumor indications: non-squamous NSCLC with wildtype EGFR-expression (wtEGFR NSCLC) (Part 2i) or mutated EGFR-expression (mutEGFR NSCLC) (Part 2ii), squamous NSCLC (Part 2iii), GEA [Part 3] will receive intravenous (IV) ABBV-400 monotherapy, participants CRC will receive intravenous (IV) ABBV-400 monotherapy in expansion [Part 4], and participants MET amplification will receive intravenous (IV) ABBV-400 monotherapy in expansion [Part 5]. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Durvalumab With Chemotherapy Followed by Sequential Radiotherapy for Limited Stage Small Cell Lung...
Limited Stage Small Cell Lung CancerThis is a single arm Phase II study, in which 6 cycles of durvalumab with chemotherapy (Etoposide and Cisplatin) and durvalumab followed by Sequential radiotherapy for limited stage small cell lung cancer.
Thoracentesis to Alleviate Cardiac Pleural Effusion
Heart FailurePleural EffusionThe present study will examine the comparative effectiveness of two treatment strategies currently used in the treatment of patients with systolic heart failure presenting with pleural effusion. Patients will be randomized to standard medical treatment only or medical treatment and referral to thoracentesis. Study hypothesis: A strategy of referring patients with heart failure-related pleural effusion to thoracentesis increases number of days alive outside of hospital over the following 90 days.
COVID-19 Vaccines in Patients With Chronic Liver Disease
Liver Disease ChronicSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused pandemic since outbreak in 2020.Patients with chronic liver disease (CLD) are at higher risk of mortality and morbidity due to COVID-19. Despite there is a large number of clinical trials of COVID-19 vaccines, only a few participants with chronic liver diseases were included.
Safety and Immunogenicity of COVID-19 Vaccination in Patients With Cancer
Patients With CancersCOVID-191 moreSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused pandemic since outbreak in 2020. Patients with cancers may be at higher risk than those without cancer for coronavirus disease 2019 (COVID-19). At present, limited data are available on the safety and immunogenicity of COVID-19 vaccination for patients with cancer.
Alectinib in Neo-adjuvant Treatment of Stage III NSCLC
Non Small Cell Lung CancerStage III NSCLC is a heterogeneous group of tumors with a wide spectrum of clinical presentations. Across this wide spectrum of heterogeneity, there is no single definitive therapeutic approach and the definition of the most effective treatment approach needs a multidisciplinary approach. In this trial we want to test in ALK positive stage III locally advanced NSCLC patients, the efficacy of Alectinib to induce tumor shrinkage when administered before surgery and to reduce the possibility of disease recurrence, with a limited risk of toxicity related, in long term administration after surgery.