A trial looking at BNT327 and chemotherapy for non small cell lung cancer (BNT327-06)

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 and you can’t have surgery or radiotherapy to treat it with the aim to cure. This is stage 3B or 3C lung cancer. Or you have cancer that has spread to other parts of the body. This is stage 4 lung cancer.
• have at least one area of cancer that your doctor can measure on a scan
• are fit and active but might not be able to do heavy physical work (ECOG performance status 0 or 1)
• have satisfactory blood test results
• 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 not to freeze or donate 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 and non small cell cancer cells
• have an EGFR gene change (mutation ) or an anaplastic lymphoma kinase (ALK) gene change in your lung cancer cells. Your doctor will know this.
• have symptoms of cancer that have spread to the brain. 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.
• have already had certain targeted cancer drugs , immunotherapies , BNT327 or similar drugs or platinum chemotherapy . This would have been treatment that you had before or after surgery for lung cancer. You can take part if you had only surgery for lung cancer.
• have had another cancer in the last 5 years. You can take part if you had successfully treated carcinoma in situ  of the cervix, ductal carcinoma insitu  of the breast, early  bladder cancer, early prostate cancer or non melanoma skin cancer  or papillary thyroid cancer.
• had any serious side effects caused by immunotherapy for another type of cancer that meant you had to stop treatment
• are taking an experimental drug or using a device as part of another clinical trial. This is if it is within 28 days of being put in a treatment group for this trial.

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 had a stroke  in the last 6 months 
• have high blood pressure that isn’t well controlled with medication
• have diabetes that isn’t well controlled with medication
• have an active autoimmune condition  or you have had one in the past apart from certain ones. Your doctor will know about this.
• have moderate to severe side effects from past treatments. You can take part if you have hair loss.
• have had antibiotics as a drip into a vein within 2 weeks of trial treatment
• have had steroids within 2 weeks of starting trial treatment unless it was a low dose. Your doctor will know this.
• 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 symptoms of spinal cord compression
• have HIV, an active hepatitis B or active hepatitis C infection that isn’t well controlled with medication or you have active tuberculosis
• 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 a serious wound that isn't healing, an ulcer or 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.
• 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 another medical condition or mental health condition that could affect you taking part or there is another reason the trial team don’t think you will be suitable

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 you are planning to become pregnant during the trial and for a period after