A trial of osimertinib for non small cell lung cancer (AURA3)
Cancer type:
Status:
Phase:
This trial compared chemotherapy with osimertinib as a second treatment for non small cell lung cancer.
The trial was for people with non small cell lung cancer (NSCLC) that had:
- spread elsewhere in the body (advanced cancer)
- got worse despite having a type of drug called a
tyrosine kinase inhibitor 
The trial was open for people to join between 2014 and 2015. Researchers published the results in 2017.
More about this trial
Some non small cell lung cancer (NSCLC) cells have changes to certain . For example, a change in the epidermal growth factor receptor (EGFR) gene. If your lung cancer cells have these receptors it is called cancer.
One of the usual treatments is a tyrosine kinase inhibitor drug such as erlotinib. But sometimes cancer develops resistance and treatment stops working. This is due to another gene change called T790M. The usual second treatment is chemotherapy.
Researchers are looking for ways to improve treatment. In this trial, they looked at a drug called osimertinib (AZD9291).
The main aims of this trial were to:
- compare chemotherapy with osimertinib to see which treatment worked best
- find out more about the side effects
Summary of results
The trial team found that osimertinib worked better than chemotherapy in people with NSCLC that had become resistant to treatment. This includes those whose cancer had spread to the brain or spinal cord.
About this trial
419 people took part in this phase 3 trial. They were put into 1 of 2 treatment groups at random:
- 279 had osimertinib
- 140 had chemotherapy with either pemextred and
carboplatin or pemextred and cisplatin
People were 2 times more likely to have osimertinib.
Results
Researchers looked at how well treatment worked. The average follow up was 8.3 months. They looked at the number of people alive whose cancer had started to grow again. This was:
- 140 people who had osimertinib
- 110 people who had chemotherapy
They also looked at how long before the cancer started to grow again. On average this was:
- 10.1 months in people who had osimertinib
- 4.4 months in people who had chemotherapy
Osimertinib in people with cancer spread to the brain or spinal cord.
116 people who joined the trial had cancer in the brain or spinal cord (CNS).
Of those:
- 46 had more than 1 area of cancer that doctors could measure on a scan (measurable lesions)
- 70 had areas that doctors couldn’t measure, for example because they were too small (non measurable lesions)
Researchers looked at how well treatment worked in these groups. They looked at the number of people whose cancer had either gone away or shrunk. This is a complete or partial response.
In people who had 1 or more areas of cancer this was:
- 7 out of 10 people (70%) who had osimertinib
- just over 3 out of 10 people (31%) who had chemotherapy
In people with areas that they either could or couldn’t measure this was:
- 4 out of 10 people (40%) who had osimertinib
- just under 2 out of 10 people (17%) who had chemotherapy
They looked at how long people with cancer in the brain lived before it got worse. This was:
- 11.7 months in people who had osimertinib
- 5.6 months in people who had chemotherapy
Side effects
People who had chemotherapy had worse side effects than those who had osimertinib.
In the osimertinib group the most common side effects were:
- diarrhoea
- skin rash or dry skin
- an infection where the nail meets the skin
The most common side effects of chemotherapy were:
- feeling sick
- loss of appetite
- constipation
- an increased risk of shortness of breath or tiredness (
anaemia )
Conclusion
The trial team found that osimertinib worked better than chemotherapy for people with T790M positive NSCLC. Including those who had cancer in the brain or spinal cord. And the side effects were manageable.
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists () and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Dr Fiona Blackhall
Supported by
AstraZeneca
Experimental Cancer Medicine Centre (ECMC)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
