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

Cancer type:

Lung cancer
Non small cell lung cancer

Status:

Open

Phase:

Phase 3

This trial is looking at adding osimertinib to chemotherapy before surgery for non small cell lung cancer (NSCLC). It is also looking at having osimertinib on its own.

It is for people who have:

  • early stage cancer or cancer that has grown into nearby tissues or lymph nodes Open a glossary item. This is stage 2 or stage 3 NSCLC.
  • changes to genes affecting a protein called EGFR Open a glossary item

More about this trial

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 Open a glossary item

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 tyrosine kinase inhibitor. It works by targeting a protein called epidermal growth factor receptor (EGFR). It stops signals that cancer cells use to divide and grow.  

Some people may have osimertinib to treat cancer that has spread to distant parts of the body. Researchers now want to see how well it works for NSCLC that hasn’t spread. 

In this trial you have 1 of the following before surgery:

  • chemotherapy (standard treatment Open a glossary item)
  • chemotherapy and osimertinib
  • osimertinib on its own

The chemotherapy drugs you have are pemetrexed with cisplatin or carboplatin

The main aims of the trial are to find out:

  • if having osimertinib before surgery improves treatment 
  • how treatment affects quality of life 
  • what happens to osimertinib in the body 
  • more about the side effects 

Who can enter

The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the 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 possible to remove with surgery (stage 2 to stage 3 B (N2) cancer
  • have cancer cells that have a change (mutation Open a glossary item) in the EGFR gene
  • are fit and active but might not be able to do heavy physical work (performance status of 0 or 1)
  • 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
  • have satisfactory blood test results
  • 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.
  • also have cancer in the lymph nodes on the opposite side of the chest from the affected lung, above the collar bone or at the top of the lung (stage 3C cancer) or you have cancer that has spread elsewhere in the body 
  • have cancer that has grown around or near you heart, your food pipe (oesophagus) or you have large areas of cancer in your lymph nodes 
  • are having a type of surgery to remove only a section of the lung 
  • are due to have radiotherapy before surgery 
  • have already had chemotherapy, a targeted drug Open a glossary item, immunotherapy Open a glossary item, or an experimental drug in the past 
  • have already had osimertinib or a similar drug that targets the EGFR gene change in the past 
  • have taken part in another trial of an experimental treatment in the last 4 weeks
  • took part in a trial of osimertinib even if you didn’t have it as part of your treatment 
  • are taking part in another study unless it doesn’t involve a treatment 
  • can’t have pemetrexed alongside cisplatin or carboplatin for any reason 
  • have had a bone marrow transplant Open a glossary item or a whole blood transfusion  Open a glossary itemwithin 120 days of giving a tissue sample looking at genetic changes 
  • have had another cancer that has got worse or needed treatment in the past 2 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, carcinoma in situ (CIS) Open a glossary item or very early melanoma skin cancer.

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

  • have a severe bleeding problem
  • 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 to treat it
  • have a problem with how your immune system Open a glossary item works 
  • have a problem with your digestive system Open a glossary item that means you can’t absorb tablets 
  • can’t swallow tablets for any reason 
  • have an abnormal heart rhythm or have a family history of a condition that causes a fast heartbeat 
  • have high blood pressure
  • have had an organ transplant Open a glossary item in the past 
  • have HIV, an active hepatitis B or hepatitis C infection or any other severe infection that needs treatment 
  • are taking medication or herbal supplements that affect the CYP enzymes
  • have had major surgery in the last 28 days. This doesn’t include having a portacath Open a glossary item put in or giving a tissue sample via 2 procedures. One is called a mediastinoscopy and the other is keyhole surgery (video assisted thoracoscopic surgery or VATS). 
  • have another medical condition or mental health problem 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 breast feeding 

Trial design

This phase 3 trial is taking place worldwide. The team need to find 351 people to take part including 5 from the UK. 

Trial treatment before surgery
It is a randomised trial.  A computer puts you into a treatment group. Neither you nor your doctor will be able to decide which group you are in. There are 3 treatment groups. 

You have 1 of the following:

  • chemotherapy and a dummy drug (placebo Open a glossary item) (group 1)
  • chemotherapy and osimertinib (group 2)
  • osimertinib on its own (group 3)

Every 2 out of 3 people will have osimertinib.

Treatment before surgery takes about 3 months in total. Osimertinib or the dummy drug are tablets. You take them once a day for about 2 months. You have osimertinib and chemotherapy at the same time if you are having both.

You have chemotherapy as a drip into a vein. You have treatment in cycles Open a glossary item. Each 3 week period is a cycle of treatment. Once every 3 weeks you have: 

  • pemetrexed and cisplatin or 
  • pemetrexed and carboplatin 

This takes 9 weeks in total.

Those having chemotherapy (group 1 and 2), also have:

  • folic acid Open a glossary item
  • a vitamin B12 Open a glossary item injection
  • steroid tablets. Open a glossary item

The team can tell you when you have these drugs and how long for. 

Surgery
Surgery is part of your routine treatment. The team check to see you are fit to have it. 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. 

You have a check up about 2 weeks after surgery to see how you are getting on. 

Some people might not be suitable to have surgery. Your doctor will explain why if this applies to you and what your treatment options are. 

Treatment after surgery
Your doctor decides if you need more treatment after surgery or not. They decide on the best option for you. This is part of your routine care. You might have radiotherapy or no treatment at all. Some people may have osimertinib. In this case you have some more tests to see if you are suitable for this treatment. Your doctor can tell you more about this. 

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 gets worse.

The researchers plan 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
  • tumour markers Open a glossary item
  • genes Open a glossary item on your cancer cells to learn more about NSCLC 
  • small pieces of DNA from cancer cells and tumours Open a glossary item

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

  • before you start treatment
  • at set times during treatment

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
  • tests to see how your lungs work 
  • a check of your lymph nodes to see if the cancer has spread
  • CT scan or MRI scan
  • PET-CT scan

You have regular COVID-19 testing during the trial. The team can tell you how often you do this. 

You have chemotherapy at the hospital on the day care ward. You see the doctor regularly during treatment. This is to see how you are and for some tests. The team can tell you more about this.

One month after surgery or the last dose of trial treatment, you see the doctor for a check up. You then see them for check ups and blood tests every 6 months for up to 5 years. You also have a CT or MRI scan at these timepoints. The trial visits and scans stop if your cancer gets worse. The team call you every 3 months to see how you are if this happens. 

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. 

We have more information about:

Location

Birmingham
Manchester
Wirral

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 Carles Escriu

Supported by

AstraZeneca

Freephone 0808 800 4040

Last review date

CRUK internal database number:

17901

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

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

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