A trial of nintedanib for mesothelioma of the lung (NEMO; EORTC 08112)

The following bullet points list 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 mesothelioma of the lung 
• have cancer that either got better or stayed the same after the first treatment you had that included pemextred and a platinum drug
• join the trial within 60 days of having your last treatment that included a platinum drug
• are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
• have satisfactory blood test results
• are willing to use reliable contraception during treatment and for at least 3 months after treatment if there is any chance you or your partner could become pregnant 
• are at least 18 years old 

Who can’t take part

You cannot join this trial if any of these apply. 

Cancer related 
You:

• have had cancer treatment including targeted drugs and chemotherapy apart from your first treatment that included a platinum drug 
• have had surgery to remove the lung and pleura called an extra pleural pneumonectomy (you might be able to join if you had surgery to remove the covering of the lung (a pleurectomy)
• have cancer that has spread to your brain or the tissues surrounding your brain - you might be able to take part if you have cancer spread to your brain that has been successfully treated, has not got any worse in the last 4 weeks and you have been on a stable dose of steroids for at least a month
• have had a targeted drug  in the past such as bevacizumab or sorafenib
• have had radiotherapy in the last 3 weeks apart from radiotherapy to control symptoms (palliative treatment )
• have had any other cancer in the last 5 years before starting the treatment in this trial 
• have scans that show you have areas of gas within the lung or areas of dead tissue in or around the cancer 
• have had treatment with an experimental drug within 4 weeks of starting treatment 

Medical conditions
You:

• have a collection of fluid in the body and or fluid on the lung 
• have a problem with the way your blood clots, bleeding, a genetic condition such as haemophilia or you are having treatment to thin the blood apart from low dose heparin or low dose aspirin 
• have coughed up a lot of blood in the last 3 months (more than one teaspoon of fresh blood a day)
• have cancer that is in the very middle of your chest on a scan or one that involves major blood vessels 
• have had a major injury or surgery within 10 days of being put into a treatment group and your wound hasn’t healed
• have surgery planned while you are taking part in the trial 
• have a heart problem such as high blood pressure that isn’t controlled with medication, angina that isn’t well controlled with medication, a heart attack in the last 6 months, congestive heart failure, an abnormal heart rhythm, or excess fluid on the heart 
• have lost more than 10% of your body weight in the last 6 weeks
• have an ulcer in your stomach or a skin ulcer
• have an active or chronic hepatitis B or hepatitis C infection 
• have a serious infection that needs treatment with antibiotics 
• can’t swallow capsules or you have a problem with your gut that affects how you absorb medication
• have any other medical condition or mental health problem that the trial team think could affect you taking part

Other 
You:

• are allergic to nintedanib or anything it contains 
• are allergic to soy or peanuts
• have a problem with drugs and alcohol that could affect you taking part in the trial