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

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 , immunotherapy  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  or carcinoma in situ
• 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  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  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 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