17 results
The objective is to assess the safety profile of the hypothermic Airdrive* oxygenated machine perfusion system for graft preservation in kidney transplantation.
To investigate the effect of a CYP3A4 inducer (rifampicin) on the PK of AZD9291.
To assess the efficacy of AZD9291 compared to placebo as measured by disease free survival (DFS)Protocol v1.0, 4Jun2015, p30
To investigate the effect of a CYP3A4 inhibitor (itraconazole) on the PK of AZD9291.
Primary objectiveTo assess the efficacy of the combination of osimertinib and bevacizumab versus osimertinib alone in terms of progression-free survival (PFS) assessed by RECIST 1.1.Secondary Objectives:To compare short and long term clinical…
To assess uptake of 11C-osimertinib in tumor lesions of T790M double positive patients and T790M double negative patients, thereby evaluating specific and aspecific (off-target) 11C-osimertinib accumulation in tumor tissue.
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…
The main objective of this study is to assess the efficacy of tepotinib combined with osimertinib inparticipants with advanced or metastatic EGFRm+ NSCLC and MET amplification, determined centrally by FISH.The secondary objectives are the following:…
Primary Objective: To monitor long-term safety of durvalumab (allcohorts)Secondary Objectives: To assess the efficacy of durvalumab in terms of ORR and DOR in patients who undergoretreatment with durvalumab (Cohort 2 only)Secondary ObjectivesTo…
The hypothesis is that the amivantamab and lazertinib combination (Arm A) will demonstrate superior PFS compared with single-agent osimertinib (Arm B).
The objective of this trial is to evaluate safety (in terms of grade >=2 pneumonitis, requiringmedical treatment) and efficacy (in terms of PFS) in patients with synchronous oligometastatic EGFR-mutant NSCLC treated with osimertinib and…
Primary objective:- To assess the efficacy of durvalumab with SoC SBRT compared to placebo with SoC SBRT in terms of PFS in patients with subset of T1 to T3N0 NSCLCOsimertinib cohort:- To assess the efficacy of osimertinib following SoC SBRT by 4…
The main objective of this pilot study is to determine the intratumoral concentrations of osimertinib upon 1 week of treatment in peritoneal metastasis of patients who are candidate for CRS-HIPEC treatment (group 1) and in liver metastasis of…
• to assess the efficacy of the sequential combination strategy of front-line afatinib-chemo, followed by a treatment with osimertinib-chemo in those patients that develop a T790M mutation as a mechanism of resistance.
-To dertermine the objective response rate (ORR) and disease control rate (DCR) (according to RECIST v1.1) after 3 months of treatment with T-DM1 and osimertinib in patients with EGFR mutation positive NSCLC and HER2 bypass track activation-To…
Patients on osimertinib with EGFR mutation exon 20, non-T790M in lung cancer. The position-20 trial.
To determine the efficacy (as assessed by best response) of osimertinib in patients with locally advanced or metastatic NSCLC and only an EGFR exon 20 mutation, deletion and/or insertion, which are T790M-ve.
Dose-finding:-To determine the adult equivalent exposure/MTD/recommended Phase II pediatric dose of durvalumab monotherapy and durvalumab in combination with tremelimumab-To determine the safety profile of durvalumab monotherapy, or durvalumab in…