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AZD9291 for Lung Cancer (AURA Trial)
AURA Trial Summary
This trial will test a new drug on patients with NSCLC who have already tried other treatments. They will look at side effects, how much of the drug is in the body, and how well it works against the cancer.
AURA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 3 trial • 29 Patients • NCT02454933AURA Trial Design
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Who is running the clinical trial?
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- You have taken erlotinib or gefitinib within the last 8 days.You must have tried a specific medication for a certain type of gene mutation and shown improvement, but then your condition got worse even with continued treatment.You have severe or uncontrolled systemic diseases, such as uncontrolled high blood pressure, active bleeding tendencies, or active infection.You have not received any chemotherapy or other cancer medications for at least 14 days before starting the study treatment.You need to have a T790M mutation test done before you can join the study.You have taken AZD9291 in this study before.You have been treated before with a specific type of medication called EGFR TKI, like gefitinib or erlotinib.If you are in the dose expansion or extension groups, you need to have a biopsy to check for a specific T790M mutation in your tumor after your most recent treatment stopped working.Your disease got worse on a previous treatment with certain medications, and you have tried other treatments that did not work.Your tumor has a specific mutation that can be treated with a type of medication called EGFR TKI.For a specific group of participants, it is required that their cancer has a certain mutation and they have not received any treatment before for their advanced cancer.You have been diagnosed with Non Small Cell Lung Cancer through a tissue or fluid sample.You have a history of lung disease or have lung problems that need treatment with steroids.You are feeling well and able to carry out your normal activities, and your doctor expects you to live for at least 12 more weeks.
- Group 1: Daily dose of AZD9291
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the maximum age limit for participants of this research?
"The trial organisers are searching for individuals of 18 years or older, but under 130 years in age."
What is the aggregate amount of participants in this clinical trial?
"At this juncture, this trial does not require any additional enrolment. The first post was made on March 4th 2013 and the last update occurred November 10th 2022. If you are in search of other studies related to lung cancer, 1908 clinical trials have open slots while 101 medical centres offer AZD9291 treatment opportunities."
What other trials have been conducted utilizing AZD9291 as a therapeutic agent?
"Currently, 101 AZD9291 studies are in progress. 17 of them have reached Phase 3 status while the rest remain at earlier stages. 4699 medical facilities across the United States, with a main hub based in Uniondale New york, are recruiting patients for these trials."
How many locales have been chosen for this scientific investigation?
"The present iteration of this clinical trial is recruiting participants from 6 medical centres, including those in Houston, Atlanta and Boston to name a few. To reduce the burden associated with travel for potential volunteers, it is advised to consider sites closest geographically."
Is this a pioneering clinical trial?
"Presently, 101 clinical trials for AZD9291 are taking place in 1059 cities and 51 nations. AstraZeneca sponsored the initial test of this medication back in 2013; 603 patients participated across Phase 1 & 2 drug approval stages. Since then, 30 studies have concluded successfully."
What criteria must potential participants meet to be eligible for this clinical investigation?
"This clinical trial is seeking 603 individuals aged between 18 and 130 suffering from lung cancer. Participants must also fulfil the following criteria: evidence of disease progression whilst on continuous EGFR TKI treatment; confirmation that tumours harbour an EGFR mutation linked to sensitivity towards such drugs (e.g G719X, exon 19 deletion, L858R or L861Q); documented clinically benefit from a previous round of ERFGR therapy per Jackman et al 2010 followed by systemic objective regression as specified in RECIST/WHO guidelines; women should be using contraceptive devices and have taken a negative pregnancy test prior to dosing comm"
Does this investigation currently require participants?
"As documented on clinicaltrials.gov, the recruitment for this medical trial has been concluded. It was initially posted in March 2013 and its information was last modified in November 2022; nevertheless, there are 2,009 other studies that have opened their enrollment process at present."
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