AZD9291 First Time In Patients Ascending Dose Study - AURA

Study identifier:D5160C00001

ClinicalTrials.gov identifier:NCT01802632

EudraCT identifier:2012-004628-39

CTIS identifier:N/A

Study Complete

Official Title

Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of AZD9291 in Patients with Advanced Non Small Cell Lung Cancer who Progressed on Prior Therapy with an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Agent

Medical condition

Advanced Non Small Cell Lung Cancer

Phase

Phase 1/2

Healthy volunteers

No

Study drug

AZD9291

Sex

All

Actual Enrollment

603

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 04 Mar 2013
Primary Completion Date: 01 May 2015
Study Completion Date: 13 Dec 2023

Study design

Allocation: N/A
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria