7 results
Primary Objective:To evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) andivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and aminimal function mutation (F/MF subjects)Secondary…
Primary Objective:To evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation (F/F)Secondary Objectives:* To evaluate the…
Primary objective:To describe the overall treatment effect of T DXd in HER2+ MBC patients with or without baseline brain metastasisSecondary objectives:- To describe the treatment effect on the development and progression of brain metastasis in…
Primary objective:1. To evaluate IDFS with T-DXd treatment as compared to T-DM1Secundary objectives:1. To evaluate DFS with T-DXd treatment as compared to T-DM12. To evaluate OS with T-DXd treatment as compared to T-DM13. To evaluate DRFI with T-DXd…
To demonstrate the safety, performance and effectiveness of the EMPOWER* Modular Pacing System (MPS), as well as the EMPOWER and EMBLEM* Subcutaneous ICD Coordinated System. Additionally, data from this study may be used to support pre-market and…
The primary objective is to evaluate the ORR of trastuzumab deruxtecan in HER2-overexpressing and/or -HER2 mutated advanced NSCLC subjects.The secondary objectives are:- To evaluate DoR, DCR, PFS, and OS.- To further evaluate the safety of…
- To assess the safety and tolerability and to determine the RP2D of T-DXd plus durvalumab in combination with cisplatin, carboplatin or pemetrexed