A trial of osimertinib for non small cell lung cancer (ADAURA2)

Cancer type:

Lung cancer
Non small cell lung cancer

Status:

Open

Phase:

Phase 3

This trial is looking at osimertinib after surgery for non small cell lung cancer (NSCLC). 

It is for people who have:

  • a small early cancer (stage 1A NSCLC)
  • had surgery or have surgery planned to remove the cancer 
  • changes to genes affecting a protein called EGFR Open a glossary item

More about this trial

Surgery is a common treatment for non small cell lung cancer. Some cancer cells have changes in particular genes and proteins. 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. 

Doctors are looking for ways to improve treatment for early NSCLC that is EGFR positive. In this trial they are looking at a drug called at osimertinib. 

Osimertinib is a type of targeted drug Open a glossary item called a cancer growth blocker. It works by targeting a protein called epidermal growth factor receptor (EGFR). It stops signals that cancer cells use to divide and grow.  

Osimertinib is already a treatment for cancer that has spread elsewhere in the body. Researchers now want to see how well it works for smaller non small cell lung cancers to stop them coming back after surgery. 

In this trial some people have osimertinib and some have a dummy drug (placebo Open a glossary item).

The main aims of the trial are to find out:

  • if having osimertinib after surgery stops the cancer coming back (recurring)
  • more about the side effects
  • how treatment affects quality of life 

Who can enter

The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or trial team if you are unsure about any of these. They will be able to advise you. 

Who can take part

You may be able to join this trial if all of the following apply. You:

  • have early stage non small cell lung cancer that is up to 3cm across or smaller (stage 1A)
  • have had or are having surgery to remove all the lung cancer. This includes having surgery to remove a lobe or segment of the lung or surgery called a sleeve resection
  • had surgery within 3 months of being put into a treatment group 
  • are completely better after surgery
  • have a sample of tissue available for the trial team to do some tests on
  • have certain gene changes in the EGFR gene to have treatment in the trial. Your doctor will check this.
  • are fit and active but might not be able to do heavy physical work (performance status of 0 or 1)
  • have satisfactory blood test results 
  • are willing to use reliable contraception during the trial and for a period after if there is any chance you or your partner could become pregnant
  • are at least 18 years old

Who can’t take part

Cancer related 
You cannot join this trial if any of these apply. You:

  • have a mix of small cell and non small cell lung cancer. Your doctor will know this.
  • are having surgery to remove either the whole lung, a wedge section of the lung or 2 lobes of the lung. Or your doctor couldn’t remove all the cancer. Your doctor will know this. 
  • have already had chemotherapy, a targeted drug Open a glossary item, immunotherapy Open a glossary item or an experimental drug in the past
  • took part in a trial of osimertinib, even if you didn’t have it as part of your treatment
  • are having another treatment for cancer 
  • have had another cancer that has got worse or needed treatment in the past 5 years unless it has a low chance of coming back. You can join if it was successfully treated non melanoma skin cancer Open a glossary item or carcinoma in situ Open a glossary item
  • have side effects from past treatments that aren’t getting better. This doesn’t include hair loss.
  • are taking part in another study unless it doesn’t involve a treatment

Medical conditions
You cannot join this trial if any of these apply. You:

  • have a severe bleeding problem
  • have an abnormal heart rhythm or you have a family history of a condition that causes a fast heartbeat
  • have high blood pressure that isn’t well controlled with medication 
  • have HIV, an active hepatitis B or hepatitis C infection or any other severe infection that needs treatment 
  • can’t swallow tablets for any reason
  • have a problem with your digestive system Open a glossary item that means you can’t absorb tablets, you feel very sick or are being sick a lot
  • have or have had a lung condition called interstitial lung disease or inflammation of the lungs or you had this in the past and needed to have steroids Open a glossary item to treat it
  • have had recent major surgery or a very bad injury 
  • are taking medication or herbal supplements that affect the CYP enzymes
  • have another medical condition that your doctor or the trial team think could affect you taking part

Other
You can’t join this trial if any of these apply. You:

  • have had a live vaccination Open a glossary item within 30 days of being put into a treatment group. Please note the current approved COVID-19 vaccines are not live.
  • are allergic to any of the drugs in the trial or anything they contain 
  • are pregnant or breastfeeding
     

Trial design

This phase 3 trial is taking place worldwide. The team need to find 380 people to take part including 10 from the UK.

Surgery
Everyone has surgery as planned. This is part of your routine care. Your doctor can tell you more about the type of surgery you will have. They can also tell you how long you’ll be in hospital for and how long it will take to get better.

Trial treatment
The treatment part is randomised. There are 2 treatment groups. A computer puts you into a group. Neither you nor your doctor will be able to decide which group you are in. Nor will you know which group you are in.

You have 1 of the following:

  • osimertinib (group 1)
  • a dummy drug (group 2)

Osimertinib and the dummy drug are tablets. You take them once a day, every day for up to 3 years. The trial team tell you exactly when you start the tablets. You start treatment no more 12 weeks after routine surgery to remove the lung cancer. 

Samples for research 
The trial team ask you to give some extra blood samples. Where possible you have these at the same time as your routine blood tests. 

They will also ask to look at samples of the cancer from your surgery. They might ask you to give a new sample if your cancer comes back. 

The researchers plan to use the samples to:

  • look at substances called biomarkers Open a glossary item to help work out why treatment might work for some people and not for others
  • look at genes Open a glossary item in your cancer cells to learn more about NSCLC 
  • measure small amounts of cancer cells that may be in the bloodstream after surgery
  • see what happens to osimertinib in the body 

Quality of life
The trial team ask you to fill out a questionnaire:

  • before you start treatment
  • at set times during treatment

You complete these on an electronic device like an I-pad or on your phone. The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

You see the doctor and have tests before you can take part. These include:

  • blood tests
  • a physical examination Open a glossary item
  • heart trace (ECG Open a glossary item)
  • heart scan (echocardiogram Open a glossary item) or MUGA scan Open a glossary item
  • eye test
  • CT scan or MRI scan

During treatment you see the trial doctor for a check up and blood tests at:

  • 3 months 
  • 6 months and then
  • every 6 months until you stop treatment

Each visit takes between 1 and 3 hours. You have a CT scan every 6 months for up to 5 years. 

Follow up
If your cancer hasn’t come back you have a check up every:

  • 6 months for 5 years
  • 9 months for 2 years and then 
  • every year until the end of the trial 

The trial visits and scans stop if your cancer comes back (recurs). Your doctor will talk to you about other treatment options. The trial team then call you every 6 months to see how you are. 

Side effects

The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better. 
 
The most common side effects of osimertinib include:

The trial doctor will talk to you about all the possible side effects of treatment.

Location

Birmingham
London
Manchester
Nottingham
Preston

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Laura Cove-Smith

Supported by

AstraZeneca

Freephone 0808 800 4040

Last review date

CRUK internal database number:

18121

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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