A trial of osimertinib for non small cell lung cancer (AURA3)

Cancer type:

Lung cancer

Non small cell lung cancer (NSCLC)

Secondary cancers

Status:

Results

Phase:

Phase 3

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 genes Open a glossary item . For example, a change in the epidermal growth factor receptor (EGFR) gene. If your lung cancer cells have these receptors it is called EGFR positive 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.

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Everyone had treatment for as long as it worked, and the side effects weren’t too bad.

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

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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

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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 (peer reviewed Open a glossary item ) 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.