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

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 ) 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 , immunotherapy , 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  or a whole blood transfusion  within 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 , carcinoma in situ (CIS)  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  works 
• have a problem with your digestive system  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  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  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  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