A trial looking at everolimus and pasireotide for neuroendocrine tumours of the lung or thymus (LUNA)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Neuroendocrine tumour (NET)

Status:

Closed

Phase:

Phase 2

This trial is looking at using either everolimus (Afinitor) or pasireotide alone, or both together, for people with neuroendocrine tumour (NET) of the lung or thymus.

Neuroendocrine tumours (NETs) are a rare group of cancers that make and release hormones. This trial is for people who have NET that started in the lung or the thymus gland Open a glossary item .

Doctors often use drugs called somatostatin analogues to help control the symptoms of NETs. Research suggests that these drugs may also help stop NETs growing. Pasireotide is a new type of somatostatin analogue.

Everolimus is a biological therapy. It stops signals that cancer cells use to divide and grow. We know from research that everolimus may be useful to treat NETs.

This trial is comparing everolimus and pasireotide together with either everolimus or pasireotide alone. The aim of the trial is to find out which is best at shrinking or slowing down the growth of neuroendocrine tumours of the lung or thymus.

Who can enter

You may be able to enter this trial if all of the following apply

You have a neuroendocrine tumour (NET) of the lung or thymus that cannot be removed with surgery or has spread to another part of your body
Your tumour can be measured and a scan shows it has grown in the last year
You have satisfactory blood test results
You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
You are willing to use reliable contraception during treatment and for 8 weeks afterwards if there is any chance you or your partner could become pregnant
You are at least 18 years old

You cannot enter this trial if any of these apply. You

Have a tumour that contains different types of cancer cells (mixed tumours). Your doctor can advise you about this
Have already had everolimus or a similar drug
Have had treatment with a long acting somatostatin analogue in the last 4 weeks or you need to take this type of drug to control symptoms
Have had a radioactive treatment such as Yttrium or radioactive iodine in the last 6 months
Have had chemotherapy or biological therapy in the last 4 weeks (or earlier if there is any chance some of the drug could still be in your body)
Have had a treatment that blocks the blood supply to your liver (hepatic artery embolisation), a treatment that uses extreme cold (cryotherapy) or a treatment called radiofrequency ablation in the last 3 months
Have had an experimental drug as part of another clinical trial in the last 4 weeks (or earlier if there is any chance some of the drug could still be in your body)
Have not recovered from side effects from any earlier treatment
Have had another cancer in the last 3 years apart carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated
Are known to be allergic or very sensitive to everolimus or pasireotide, or to similar drugs (or anything they contain)
Have had radiotherapy in the last 4 weeks (you may be able to join if your radiotherapy was to control symptoms and you have recovered from any side effects)
Have had any major surgery in the last month or surgery to remove an area of cancer spread (metastases) in the last 3 months
Have liver disease such as cirrhosis or Hepatitis B or C, or you drink an amount of alcohol that concerns the trial team
Have a medical condition affecting your gallbladder or bile duct or inflammation of the pancreas (acute pancreatitis)
Have gallstones that are causing symptoms
Have certain heart problems (the trial team can advise you about this)
Are HIV positive
Have another medical condition that could affect you taking part in this trial (the trial team can advise you about this)
Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. This international trial will recruit 120 people across Europe.

It is a randomised trial. The people taking part will be put into 1 of 3 treatment groups by a computer. Neither you nor your doctor can choose which group you are in.

People in group 1 have everolimus
People in group 2 have pasireotide
People in group 3 will have both everolimus and pasireotide

LUNA trial diagram

Everolimus is a tablet. You take 2 tablets once a day, with or without food. You need to avoid eating grapefruit, Seville oranges and marmalade and drinking grapefruit juice while taking part in the trial as these can all stop everolimus from working properly.

You have pasireotide as an injection into the muscle once every 4 weeks.

You have treatment for 12 months. But if your tumour is not getting worse and you don’t have bad side effects, you may be able to carry on having treatment for longer.

Hospital visits

You see the doctor and have some tests before you start treatment. These tests may include

A physical examination
Blood tests
Heart trace (ECG )
Heart scan (echocardiogram ) or MUGA scan )
CT scan
MRI scan
Octreoscan
Urine samples

You go to hospital 3 times during the 1st month of treatment then every 4 weeks after that. If you have pasireotide, you have an extra visit about 3 weeks after your 2nd injection.

You cannot eat or drink anything apart from water for 8 hours before each hospital appointment.

During treatment you have a heart trace every 2 to 4 weeks to begin with and then every 3 months. You will have a CT, MRI or octreoscan every 3 months. At most visits you have a blood test and give a urine sample.

If you have pasireotide the trial team will ask you to check your blood sugar throughout your treatment. They will give you a blood sugar monitor and instructions on how to use it. They will also give you a diary to record the results. Approximately 10 days after your 1st and 5th treatments, the trial team will call you to ask for your blood sugar results.

If your blood sugar level is high on any 2 separate occasions or is very high on any occasion, you will need to contact the trial team immediately as you may need to go to hospital.

If you stop treatment because of side effects you will have a CT or MRI scan every 3 months until you either start a new treatment or you cancer begins to grow again.

The trial team will contact you around 2 months after you finish treatment to see how you are.

Side effects

The possible side effects of pasireotide include

Feeling sick
Diarrhoea
Tummy (abdominal) pain
Constipation
Wind (flatulence)
Headache
High blood sugar (hyperglycaemia)
Gallstones
Inflammation of the gallbladder (cholecystitis )

As with any new treatment, it is possible that there could be some side effects the doctors don’t know about yet.

The most common side effects of everolimus include

Lung or breathing problems
Infections
Sore mouth
Shortness of breath
Loss of appetite and weight loss
Headache
Cough
Diarrhoea
Feeling or being sick
Rash, dry itchy skin
Skin or nail changes
Tiredness (fatigue)
Feeling weak
Nose bleeds
Changes in taste
Pain or swelling of the arms or legs
Inflammation of the tissues that line your throat, your gut (digestive system), or other parts of your body (mucous membranes)