7 results
MAIN OBJECTIVESDose escalation study:To establish the safe use of trastuzumab (Synthon BV, the Netherlands) in healthy volunteers at different dose levels up to 6 mg/kg.Bioequivalence study:Demonstrate bioequivalence between trastuzumab (Synthon BV…
Primary Objectives:- To assess the efficacy of durvalumab + dCRT compared with placebo + dCRT in all randomized patients based on PFS (per RECIST 1.1 as assessed by BICR)- To assess the efficacy of durvalumab + dCRT compared with placebo + dCRT in…
To evaluate PFS in participants treated with cCRT plus M7824 followed by M7824 or cCRT plus placebo followed by Durvalumab
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…
This study is being conducted to evaluate the efficacy and safety of durvalumab adjuvant therapy compared to placebo in patients with completely resected stage II-III NSCLC who have undergone curative intent therapy (complete resection ± neoadjuvant…
The research hypothesis for this study is that concurrent durvalumab plus SoC chemotherapy will be more effective than placebo plus SoC chemotherapy for the treatment of MRD+ patients who have undergone complete resection of stage II-III NSCLC when…
Primary objective:To compare Arm A relative to Arm B on event-free survival (EFS)Key secondary objectives:- To compare Arm A relative to Arm B on overall survival (OS)- To compare Arm A relative to Arm B on pathological complete response (pCR) rate