Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors, AZD3759 or AZD9291, in patients who have Advanced Non-Small Cell Lung Cancer - BLOOM

Study identifier:D6030C00001

ClinicalTrials.gov identifier:NCT02228369

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumour Activity of AZD3759 or AZD9291 in Patients with EGFR Mutation Positive Advanced Stage Non Small Cell Lung Cancer (NSCLC)

Medical condition

EGFR Mutation Positive Advanced Non Small Cell Lung Cancer

Phase

Phase 1

Healthy volunteers

No

Study drug

AZD3759, AZD9291

Sex

All

Actual Enrollment

108

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 05 Nov 2014
Primary Completion Date: 19 Aug 2017
Study Completion Date: 28 Oct 2020

Study design

Allocation: Non-randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2021 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria