A trial looking at MK-2870 for non small cell lung cancer (MK-2870-007)

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 non small cell lung cancer (NSCLC) that has spread to another part of the body (stage 4).
• At least half of the cancer cells have the PD-L1 protein. Your doctor tests for this using a small piece of the cancer tissue. This could be from a sample of the cancer tissue (biopsy ) that was taken to confirm your cancer has spread. You might need to have a fresh biopsy taken if this isn’t available. Your doctor will discuss this with you. 
• You are willing to use reliable contraception during treatment and for a period of time after treatment if there is any chance you or your partner could become pregnant.
• You have an area of cancer the doctor can measure.
• You are able to look after yourself but might not be able to do heavy physical work (performance status 0 or 1).
• You have satisfactory blood test results.
• You 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 type of lung cancer that is called small cell lung cancer
• have a mixed type of lung cancer and one type is small cell cancer 
• have already had treatment for NSCLC that has spread  
• have had previous treatment that targets PD-1, PD-L1 or PD-L2. You can join if you had one of these treatments for NSCLC that had not spread and could not be removed by surgery. This is as long as you had completed treatment at least 1 year before your cancer had spread. 
• have had treatment that helps the immune system find and kill cancer (immunotherapy ). Your doctor will know this. 
• have had radiotherapy to the lung that was more than 30 Gray(Gy)  within 6 months of starting the trial treatment
• have had a cancer treatment within 4 weeks of being put into a trial treatment group (randomisation )
• have cancer that has spread to the brain and spinal cord or the tissue surrounding them. This is unless it has been treated, it is stable and you have not needed steroids within 2 weeks of starting trial treatment.
• have another cancer that has needed treatment or had got worse within the past 3 years. This is apart from successfully treated non melanoma skin cancer , any carcinoma in situ (CIS) apart from bladder CIS. You can join if you have low risk early stage  prostate cancer that has been treated with the aim to cure or the cancer is stable and you are in active surveillance.
• have moderate to severe ongoing side effects from previous cancer treatment 

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

• have certain gene changes (mutations ) in the cancer cells. Your doctor will know more about this. 
• have one of the following medical conditions: dry eye syndrome, Meibomian gland disease, swollen and itchy eyes (blepharitis) or a condition that affects the outer layer of the eye (cornea) and how it heals
• have an inflammatory bowel disease such as Crohn’s disease, ulcerative colitis or chronic diarrhoea, which needs treatment with medication that damps down the immune system. Or you have had an inflammatory bowel disease.
• have an ongoing serious heart problem  or one within 6 months of starting trial treatment and it is not controlled 
• have had an experimental drug or use a device as part of another trial within 4 weeks before randomisation 
• have medication that affects the CYP3A4 enzyme within 2 weeks of starting trial treatment
• have radiotherapy within 2 weeks of starting trial treatment. For radiotherapy to relieve symptoms (palliative radiotherapy) it is less than 2 weeks, as long as the treatment is completed within a week of starting trial treatment. This is apart from palliative radiotherapy to treat cancer that has spread to the brain and spinal cord. 
• have had medication that works in the same way as MK-2807. Your doctor will know if you have.
• have an immune system  that is not working very well. Or you are taking medication that affects how well the immune system works within 7 days of starting trial treatment. This is apart from a small dose of steroids .
• have an active autoimmune disease  that needed treatment within the past 2 years. This is apart from medication to replace what the body would make such as insulin for diabetes and hormones to replace those made by the thyroid gland .
• have inflammation of the lungs or lung tissue that was not caused by an infection. Or you have had steroids to treat either of these in the past.
• have an active infection that needs treatment that reaches the whole body such as an antibiotic tablet or drip
• have both active hepatitis B and active hepatitis C. Or you have had either only hepatitis B or only hepatitis C. You might be able to join if you are taking medication to treat hepatitis B or hepatitis C. Ask your doctor about this.
• have HIV and you have or had Kaposi’s sarcoma, Multicentric Castleman’s disease or both. You can join if you do have HIV as long as it is well controlled with anti-retroviral therapy (ART). 
• have had a stem cell or bone marrow transplant from a donor (allogeneic transplant) or an organ transplant
• have not recovered from major surgery or you have ongoing complications from surgery
• have moderate to severe nerve damage (peripheral neuropathy) 
• have any other medical condition, mental health problem or a substance abuse problem that would affect you taking part in the trial

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

• are allergic or sensitive to the treatment used in this trial, their ingredients or similar drugs
• have a live vaccine  within 30 days before starting trial treatment. You cannot have a live vaccine for 30 days after completing treatment. The COVID-19 vaccines are not live vaccines. 
• are pregnant or breastfeeding