A trial looking at the combination of a targeted drug and immunotherapy for non small cell lung cancer (KEYLINK-006)

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 non small cell lung cancer (NSCLC) that is a non squamous cell type 
• have stage T4 NSCLC that has spread to another part of the body (M1) 
• have an area of cancer the doctor can measure 
• have a sample of cancer tissue that the trial team can access either from when you were diagnosed or if this isn’t available you have a new sample (biopsy ) taken
• are active but might not be able to do heavy physical work (performance status 0 or 1)
• have satisfactory blood test results
• are willing to use reliable contraception during treatment and for 6 months after 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 treatment that reaches your whole body (systemic treatment ) for your advanced NSCLC including chemotherapy and targeted drugs. You might be able to join if you had chemotherapy before surgery or radiotherapy to shrink the cancer or you had chemotherapy after surgery or radiotherapy and your cancer spread developed at least a year after this. 
• have the gene changes (mutation) for EGFR, ALK or ROS1 in your cancer cells
• have cancer that is mostly squamous cell lung cancer  
• have cancer that has spread to your brain or spinal cord that is growing or causing symptoms. You might be able to join if your cancer spread isn’t growing or causing symptoms. Or you have treated cancer spread that isn’t growing and there are no symptoms for at least 2 weeks and you haven’t had steroids for at least 3 days before starting treatment
• have had radiotherapy to the lung with a dose of greater than 30 Gray  (Gy) within 6 months of starting treatment
• have had radiotherapy to relieve symptoms within 7 days of starting treatment. You must also have no ongoing side effects of the radiotherapy and not need to have steroids. 
• have had treatment that affects your immune system (immunotherapy)
• have had treatment that affects a protein called PARP (a PARP inhibitor)
• have another cancer that is growing or has grown in the past 3 years and needed treatment apart from successfully treated non melanoma skin cancer  or any carcinoma in situ  
• are sensitive to any drug used in this trial or any of their ingredients
• are expected to need other any other anti cancer treatment during the trial

Medical conditions

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

• have an autoimmune disease  that has needed treatment that reaches the whole body in the past 2 years apart from medication that replaces a substance in the body such as insulin, hormones for a thyroid gland that isn’t working well and steroids for adrenal glands or pituitary gland that aren’t working well
• have an immune system that isn’t working well or taking a dose of steroids that is more than 10mg per day or any other medication that affects the immune system within 7 days of treatment
• have inflammation of the lungs (pneumonitis ) or had pneumonitis in the past that needed treatment with steroids
• have had a lung disease that affected the tissues of the lung and the space around the air sacs (interstitial lung disease)
• have an active infection that needs treatment that reaches the whole body
• have HIV
• have hepatitis B
• have an active hepatitis C infection
• have active tuberculosis (TB) infection
• have symptoms of having fluid on the lung (pleural effusion ) or fluid on the abdomen (ascites ). You might be able to join if you have pleural effusion or ascites that isn’t getting any worse (is stable) after treatment for it
• have or have signs of the blood cancer myelodysplastic syndrome  (MDS) or acute myeloid leukaemia (AML)
• have had major surgery within 3 weeks of starting treatment
• still have ongoing side effects or complications of major surgery 
• are taking a non steroidal anti inflammatory drug  (NSAID) such as aspirin and you can’t stop it apart from a small dose of aspirin for 5 days
• are not able or not willing to take folic acid or vitamin B12
• have had treatment such as GCSF or GMCSF to help your bone marrow make blood cells in the past 28 days before starting treatment
• are taking medication that strongly or moderately affects the CYP enzymes 
• are taking an experimental drug as part of another clinical trial within 4 weeks of starting treatment. You might be able to join if you are in follow up and have stopped taking the experimental drug for 4 weeks.
• have a heart trace (ECG ) that shows you have certain heart conditions that medication can’t control or treat well
• can’t swallow tablets or capsules
• have a problem with your digestive system  that means your body can’t absorb the medication 
• have had an organ transplant
• have had a stem cell or bone marrow transplant from another person (allogeneic transplant )
• have any other medical condition or mental health problem that your doctor or the trial team think could affect you taking part 

Other

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

• have had a live vaccine  within 30 days of starting treatment
• are pregnant or breastfeeding