12 results
Primary Objective: To compare Overall Survival (OS) of subjects with Stage IV/recurrent NSCLC of squamous histology who have been randomized to ipilimumab in addition to paclitaxel and carboplatin versus placebo in addition to paclitaxel and…
Primary: treatment effect of BKM120 once daily plus weekly paclitaxel versus BKM120 matching placebo once daily plus weekly paclitaxel on progression-free survival for each of the two groups, namely 1) PI3K pathway activated patients and 2) full…
Main objective:The primary objective is to demonstrate that combination therapy using finerenone and empagliflozin is superior in reducing UACR than either empagliflozin or finerenone alone.Secondary objectives:- To further investigate the efficacy…
The main goal of this study is to find out whether finerenone in combination with either an ACE inhibitor or an ARB can reduce the amount of protein in the participants' urine more than a placebo. A placebo looks like a drug, but contains no…
To demonstrate the superiority of finerenone to placebo in reducing the rate of the composite CV endpoint.To determine superiority of finerenone to placebo for each secondary endpointTo assess the safety and tolerability of finerenone
Demonstrate whether, in addition to standard of care, finerenone is superior to placebo in delaying the time to first occurrence of cardiovascular mortality and morbidity in subjects with T2DM and the clinical diagnosis of DKD.
Demonstrate whether, in addition to standard of care (SoC), finerenone is superior to placebo in delaying the progression of kidney disease, as measured by the composite endpoint of time to first occurrence of kidney failure, a sustained decrease of…
Primary:In 1L subjects with metastatic squamous non-small cell lung cancer (NSCLC) receiving investigator*s choice of standard of care chemotherapy (i.e. carboplatin and a taxane):1. Evaluate progression free survival (PFS) per RECIST 1.1 as…
The purpose of this study is to compare the effectiveness of treatment Arm A and Arm B by measuring the event free survival (EFS) and pathological complete response (pCR). EFS is defined as the time from the first treatment dose that the patient…
This Phase III study, the administration of durvalumab + chemotherapy prior to surgery, followed by administration of durvalumab after surgery, will be investigated in patients with resectable Stages II and III NSCLC. The efficacy of durvalumab will…
Primary: Safety run-in part (part 1):• Recommended Phase 3 dose regimen (RP3R) of canakinumab in combination with pembrolizumab plus chemotherapy. Double-blind, randomized, placebo-controlled part (part 2):• Progressive free survival (PFS) between…
Primary Objective:- To demonstrate the superiority of palbociclib in combination with fulvestrant (with or without goserelin) over fulvestrant alone (with or without goserelin) in prolonging investigator-assessed PFS in women with HR+/HER2-negative…