A study looking at chemotherapy, pembrolizumab and lenvatinib for neuroendocrine tumours (PELICAN)

The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study 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 study if all of the following apply. You:

• have a neuroendocrine tumour and the cancer cells look very abnormal. This is also called a grade 3 (high grade) poorly differentiated neuroendocrine carcinoma (NEC).
• have a measurement score called a Ki-67 index of more than 20% - this means that more than 2 in every 10 cancer cells (20%) are dividing. Your doctor will know this.
• have cancer that a doctor can measure on a scan
• have not had treatment that reaches your whole body (systemic treatment) for cancer that has spread to another part of the body
• have satisfactory blood test results
• are willing to use reliable contraception during treatment and for a period afterwards if there is any chance you or your partner could become pregnant
• are well enough to be up and about for at least half the day but might not be able to work (performance status 0, 1 or 2) 
• are at least 18 years old

Who can’t take part

Cancer related
You cannot join this study if any of these apply. You:

• have either small cell lung cancer (SCLC) or large cell lung cancer
• have Merckel cell cancer
• have had had radiotherapy within 2 weeks of starting treatment or you have certain ongoing radiotherapy side effects. You might be able to take part if you have had radiotherapy a week before starting treatment if it was for symptom control.
• have cancer that has spread to the brain, or spinal cord unless it isn’t causing symptoms, has been treated and is stable
• have had any other cancer unless you’ve had treatment with no sign of your cancer for at least 3 years since starting treatment. This is apart from successfully treated carcinoma in situ of the cervix, non melanoma skin cancer , early non invasive bladder cancer or other very early cancers. Your doctor will know more.
• have had certain checkpoint inhibitors before, these are anti PD-1, anti PD-L1 or anti PD-L2 drugs. Your doctor will know this.

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

• have a problem with your immune system or have had treatment that damps down the immune system. This includes steroids within one week of starting study treatment unless it is a low dose.
• have an active infection that needs treatment that reaches your whole body (systemic treatment)
• have HIV, hepatitis B, active hepatitis C or active tuberculosis (TB)
• have had pneumonitis which was not caused by infection and needed steroid treatment. Or you have pneumonitis at the moment.
• have scarring of the lungs called interstitial lung disease
• have an active autoimmune condition that needed treatment in the past 2 years apart from certain ones. Your doctor will know this.
• have high blood pressure that isn’t well controlled with medication
• have had a major heart problem such as a heart attack in the 6 months before starting the study treatment
• have a bleeding or clotting problem which means you are at risk of a severe bleed
• have protein in your urine. Your doctor will check this.
• have had major surgery within 3 weeks of your first dose of study treatment
• have any other medical condition or mental health condition that might affect you taking part in the study

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

• have had a live vaccine within 30 days of the start of study treatment. Please note that the COVID-19 vaccine is allowed as it isn’t a live vaccine.
• have taken part in another study looking at an experimental drug or device within 4 weeks of having treatment in this study
• are allergic to lenvatinib, pembrolizumab, carboplatin or etoposide. Or anything that they contain.
• are pregnant or breastfeeding