9 results
The primary objective of the study is to compare the efficacy of brigatinib to that of crizotinib in ALK+ locally advanced or metastatic NSCLC patients naive to ALK inhibitors, as evidenced by PFS.The secondary objectives of the study are:1. To…
Primary objectives• To identify the percentage of patients in which a drug resistant clone can be detected with ctDNA before the emergence of radiological progression.• To determine the success rate of crizotinib and osimertinib combination…
Primary objectives To demonstrate the non-inferiority of CHF 5993 pMDI versus fixed combination of fluticasone furoate/vilanterol plus tiotropium in terms of quality of life (change from baseline in the St. George*s Respiratory Questionnaire [SGRQ]…
This study will evaluate the efficacy and safety of entrectinib compared with crizotinib in patients who have NSCLC harboring ROS1 gene rearrangements with and without CNS metastases. Specific objectives and corresponding endpoints for the study are…
Primary:To evaluate the efficacy and safety of Ensartinib vs. crizotinib in patients with ALK-positive NSCLC that have received up to 1 prior chemotherapy regimen and no prior ALK tyrosine kinase inhibitor (TKI).Secondary:To obtain additional…
NMOSD is associated with a high degree of disability and mortality, and there is a unmet medical need in children with this disease.Results from the pivotal study (Study CD-IA-MEDI-551-1155) in adult patients with NMOSD demonstrated a 77% reduction…
Primary• To determine the RP2D of crizotinib in combination with temsirolimus • To determine the safety and preliminary activity of single-agent crizotinib in ALK, MET or ROS1 positive tumors Secondary• To study the preliminary activity of…
To demonstrate that lorlatinib as a single agent (Arm A) is superior to crizotinib alone (Arm B) in prolonging Progression-Free Survival (PFS) in advanced ALK-positive NSCLC participants who are treatment naive.
Primary objective: To evaluate the efficacy of inebilizumab in reducing the risk of a disease flare in patients with IgG4-RD.Secondary objectives:• To evaluate the safety and tolerability of inebilizumab in patients with IgG4-RD.• To evaluate the…