A trial looking at celecoxib with standard treatment for certain types of cancer that have spread (LION Trial)

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 main entry conditions apply. You:

• have cancer that has spread into surrounding tissues or to other parts of the body 
• have at least one area of cancer that hasn’t been treated with radiotherapy that your doctor can measure on a scan 
• have satisfactory blood test results 
• have a sample of tissue that was taken within 3 months of joining the trial 
• are suitable to have a type of immunotherapy called an immune checkpoint inhibitor 
• are fit and active but might not be able to do heavy physical work (performance status 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 
• are at least 18 years old 

Triple negative breast cancer group
As well as the main entry conditions above, the following must also apply for this group. You:

• have triple negative breast cancer confirmed with a recent tissue sample
• have the protein PD-L1 on the breast cancer cells 
• can’t have surgery to remove the cancer 

Non small cell lung cancer group
As well as the main entry conditions above, the following must also apply for this group. You:

• have NSCLC recently confirmed with a tissue or fluid sample  
• have the protein PD-L1 in more than half of the lung cancer cells. Your doctor will know this. 
• have no evidence of the EGFR gene change (mutation ), the ALK gene change or the ROS1 gene change in your cancer cells. Your doctor will check this. 
• may have previously had chemotherapy for cancer that hadn’t spread. The last dose you had must have been more than 6 months before your cancer got worse. 

Renal cell cancer group
As well as the main entry conditions above, the following must also apply for this group. You:

• have clear cell or papillary cell renal cancer
• have medium to high risk renal cell cancer. Your doctor will know this.

Who can’t take part

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

• have already had treatment for incurable cancer that has spread to surrounding tissues or to other parts of the body
• are having chemotherapy, an experimental treatment or a targeted cancer drug . You can take part if you are having bisphosphonates or denosumab for cancer spread to the bone.
• have cancer that has spread to the brain or spinal cord and is causing symptoms or your doctor suspects you have this. You can take part if you have had treatment, the cancer is stable and you have stopped taking steroids.
• have cancer that has spread to the tissues that cover the brain and spinal cord 
• have had another cancer in the last 5 years. You can take part if you have successfully treated non melanoma skin cancer , in situ cancer of the cervix, ductal carcinoma of the breast or early stage cancer of the womb.

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

• have had a heart attack or heart surgery in the last 6 months or a significant heart problem that needs treatment 
• are taking certain medications that you can’t have in the trial. Your doctor will know this. 
• break down some medicines in the body very slowly. Your doctor will test for this. 
• have an autoimmune condition that needs treatment apart from certain ones. Your doctor will know about this. 
• have had treatment that damps down the immune system . This includes steroids within 2 weeks of starting trial treatments unless it was a low dose.
• have scarring on the lungs that is causing symptoms or could interfere with monitoring side effects that affect the lung.
• have side effects from past treatment that aren’t getting better. You can take part if you have hair loss or white patches on your skin. 
• have HIV, an active hepatitis B or hepatitis C infection or another infection that needs treatment to the whole body
• regularly take aspirin, you took it regularly in the past or you take a type of drug called a non steroidal anti inflammatory drug 
• have another medical condition or mental health condition that could affect you taking part in the trial or there is another reason the trial team think you won’t be suitable to take part 

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

• are allergic to celecoxib 
• are allergic to a type of drug called a sulphonamide
• have had a live vaccination within 30 days of joining the trial. This is apart from the seasonal flu vaccine or the approved COVID-19 vaccines as these aren’t live.
• are pregnant or breastfeeding