A trial looking at BAY 2927088 as a treatment for non small cell lung cancer that has spread

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 into surrounding tissues (stage 3 cancer) and you can’t have surgery to remove it. Or you have cancer that has spread to other parts of the body. This is stage 4 cancer.
• have a sample of tissue (biopsy ) from a previous sample that the team can use to do some tests on. Or you are willing to have a new sample taken if a previous sample isn’t available.
• have had a tissue sample taken in the past that shows you have a gene change (mutation ) in the HER2 gene
• have an area of cancer that the doctor can measure 
• are suitable to have cisplatin and pemetrexed or carboplatin and pemetrexed, in combination with pembrolizumab
• can swallow and absorb tablets 
• have satisfactory blood test results 
• 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 
• 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 squamous cell NSCLC
• have a mixture of small cell and non small cell cancer cells 
• have cancer that has spread to the brain or spinal cord or the thin tissue layers that cover them. You can take part if you have had treatment, the cancer has been stable for at least 6 weeks and you have stopped taking steroids or you are taking a low dose.
• have already had systemic treatment for NSCLC that has spread 
• have had treatment that targets HER2 such as poziotinib, trastuzumab deruxtecan or a similar drug in the past. You might be able to take part if you had this type of treatment just before or after surgery as long as you finished this more than 12 months ago.
• have another gene change in the cancer cells and you could have a standard targeted cancer drug to treat this. Your doctor will know this. 
• have had BAY 2927088 or a similar drug in the past 
• had radiotherapy within 21 days of starting trial treatment. This is apart from radiotherapy to the brain. If you have had radiotherapy, any side effects must be better and you have stopped taking steroids. 
• have had major surgery in the last 4 weeks or you have surgery planned within 6 months of joining this trial
• are taking an experimental drug or using a device as part of a clinical trial within 4 weeks of joining this trial
• have had another cancer in the last 5 years unless it has been successfully treated and there have been no signs of it since. You can take part if you had successfully treated carcinoma in situ of the cervix, breast or skin, early bladder cancer, early prostate cancer or non melanoma skin cancer .

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

• have had a heart attack in the last 6 months or a significant heart problem that isn’t well controlled with medication. Your doctor checks your heart before you join the trial.
• have had a stroke or mini stroke in the last 6 months 
• have a problem with how your liver or kidneys work 
• are having long term steroid treatment unless it is a low dose
• have or have had scarring on the lungs or inflammation of the lungs (pneumonitis ) that needed treatment in the past 
• have had an organ transplant
• have digestive system problems that means you can’t absorb BAY 2927088
• have a serious wound that isn’t getting better or a bone fracture
• have moderate to severe side effects from past cancer treatments. You can take part if you have hair loss or skin colour changes. You might be able to take part if you have some moderate side effects as long as they are stable. Your doctor will know this. 
• have an autoimmune condition that needed treatment in the last 2 years apart from certain ones. Your doctor will know about this. 
• have HIV. You might be able to take part if you are having treatment and it is stable.
• have hepatitis C, active hepatitis B that isn’t well controlled or any other severe infection
• have a significant bleeding problem 
• take medication that affects substances in the body called CYP enzymes within 2 weeks of starting trial treatment or you take these medications regularly for uncontrolled fits. Your doctor can tell you more about this.
• can’t or won’t take folic acid or vitamin B supplements. This only applies if you are in the group having pemetrexed. 
• have another medical condition or mental health condition or there is any other reason the team think you won’t be suitable for the trial  

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

• have had a live vaccination within 30 days of starting treatment. You can take part if you have had the seasonal flu vaccine or the approved Covid-19 vaccines as these aren’t live.
• are allergic to BAY 2927088, any of the standard treatments or anything they contain 
• have had a severe allergic reaction to a type of drug called a monoclonal antibody in the past 
• are pregnant or breastfeeding