A trial looking at BNT327 and chemotherapy for small cell lung cancer (BNT327-03)

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 extensive stage small cell lung cancer. This means the cancer has spread within the chest or to other parts of the body. You might also be able to take part if your cancer has spread more widely within the lung and cannot be treated with chemoradiotherapy . Your doctor will know this.
• have at least one area of cancer that your doctor can measure on a scan
• have satisfactory blood test results
• 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. You must also be willing to not donate or freeze eggs or donate sperm during the trial and for a period after.
• 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 mixture of small cell lung cancer cells and other types of cancer cells
• have cancer that has spread to the brain or spinal cord. You can take part if you have had treatment, the cancer has been stable and you stopped taking steroids  within 10 days of starting trial treatment. You can’t take part if the cancer has spread to the thin tissue layers that cover the brain or the cancer in the brain measures more than 2cm across.
• have already had cancer treatment to the whole body for extensive stage small cell lung cancer. You may be able to take part if you have had chemoradiotherapy , immunotherapy , radiotherapy or chemotherapy for limited stage small cell lung cancer   and had no signs of cancer for at least 6 months after the last treatment.
• have already had treatment with BNT327 or a similar drug
• are taking an experimental drug or using a device as part of another clinical trial. This is if it is within 3 weeks of being put in a treatment group for this trial.
• had any serious side effect caused by immunotherapy for another cancer or condition or for limited stage lung cancer that meant you had to stop treatment
• have already had radiotherapy or certain targeted cancer drugs . This is within 2 to 4 weeks of starting trial treatment. This time period depends on the type of drug you had and where you had radiotherapy. Your doctor will check this. You can take part if you had radiotherapy to the brain or bone.
• have had another cancer in the last 4 years. You can take part if you had successfully treated carcinoma in situ  of the cervix, ductal carcinoma in situ  of the breast, early  bladder cancer, early prostate cancer, non melanoma skin cancer  or papillary thyroid cancer.

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

• have had a heart attack or a significant heart problem  within the last 6 months. Your doctor checks your heart before you join the trial.
• have high blood pressure that isn’t well controlled with medication
• have had a major bleeding problem or you have a risk of developing this. Your doctor will know this. 
• have a collection of fluid on your lungs, around your heart or in your tummy (abdomen) that needs to be drained often. You might be able to take part if these conditions are stable.
• have a serious wound that isn't healing, an ulcer or a bone fracture  within 6 months of joining the trial. You can’t take part if you had or have a risk of a fistula  in your abdomen , an abnormal opening between the windpipe and the food pipe, a hole or tear in the gut or a collection of pus in the abdomen in the last 6 months. These conditions must have resolved to take part in the trial.
• have had a sudden life threatening increase in blood pressure or high blood pressure that has affected the brain. Your doctor will know this. 
• have had antibiotics as a drip into a vein within 2 weeks of starting trial treatment
• have had major surgery, a significant traumatic injury or an invasive dental procedure such as dental implants within 28 days of starting trial treatment or you plan to have surgery during the trial
• have had a stem cell transplant using donor stem cells  or an organ transplant  in the past
• have an active autoimmune condition  or you have had one in the past apart from certain ones. Your doctor will know about this.
• have had steroids  within 10 days of starting trial treatment unless it was a low dose. Your doctor will know this.
• have HIV, an active hepatitis B or active hepatitis C infection that isn’t well controlled with medication, tuberculosis  or an active syphilis infection
• have moderate to severe side effects from past treatments. You can take part if you have hair loss.
• have symptoms of spinal cord compression
• have a blockage in a large vein in the chest called the superior vena cava. Your doctor will know about this.
• have or had scarring on the lungs or inflammation of the lungs (pneumonitis ) that needed treatment in the past
• have another medical condition or a mental health condition that could affect you taking part or there is another reason that the trial team don’t think you will be suitable to join this trial. 

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

• are allergic to any of the treatments in the trial or anything they contain
• 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 pregnant or breastfeeding or planning to become pregnant during the trial and for a period after