drugset / Trial / NCT02228369

Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors, AZD3759 or AZD9291, in Patients Who Have Advanced Non-Small Cell Lung Cancer

NCT02228369

Phase 1 Completed 108 enrolled AstraZeneca
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is the first time in patient study to assess the safety, tolerability and preliminary efficacy of AZD3759 in patients with advanced Non Small Cell Lung Cancer (NSCLC) In this study, patients with Leptomeningeal Metastasis and Brain Metastasis may also be enrolled to assess the anti-tumour efficacy, safety, pharmacokinetics and potential biological activity of AZD9291

Timeline

Start
2014-11-05
Primary completion
2017-08-19
Completion
2020-10-28

Drugs

EvaluationDrugModalityDoseRoute
Subject AZD3759 Small molecule 50 mg Oral
Subject AZD3759 Small molecule 100 mg Oral
Subject AZD3759 Small molecule 200 mg Oral
Subject AZD3759 Small molecule 300 mg Oral
Subject AZD3759 Small molecule 500 mg Oral
Subject Osimertinib Small molecule 160 mg Oral

Indications