16 results
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 inducer (rifampicin) on the PK of AZD9291.
• 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.
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 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:…
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.
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…
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…
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…
-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.
The hypothesis is that the amivantamab and lazertinib combination (Arm A) will demonstrate superior PFS compared with single-agent osimertinib (Arm B).
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 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…