Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A study looking at a drug called AZD6244 in combination with radiotherapy in people with non small cell lung cancer (MEKRT trial)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking for the dose of AZD6244 that you can have safely with radiotherapy to treat non small cell lung cancer.
If you have a type of lung cancer called non small cell lung cancer that is either stage 3 or 4, you may have radiotherapy. You may have this at the same time as chemotherapy, to try to cure your cancer. Or if the cancer is more advanced, you may have radiotherapy to control symptoms.
Doctors in this study want to see if they can improve treatment for these stage 3 and 4 non small cell lung cancers. They will combine radiotherapy with a drug called AZD6244. AZD6244 is a type of drug called a MEK inhibitor. It works by blocking growth signals. MEK stands for mitogen activated protein kinase. This is a protein that sends signals to cells telling them to divide and grow. Researchers hope that AZD6244 will reduce the amount of MEK and slow down or stop the growth of cancer. We also know from research that AZD6244 helps radiotherapy to work better.
This study is the first time AZD6244 has been used in combination with radiotherapy. The aim of this study is to find out the dose of AZD6244 that you can have safely with radiotherapy for non small cell lung cancer.
Who can enter
You may be able to enter this study if
- You have non small cell lung cancer that is stage 3 and can’t be removed with surgery, or you have stage 4 non small cell lung cancer and you have severe symptoms affecting your chest
- You could be treated with intensive radiotherapy aimed to cure your cancer (radical radiotherapy) and you are well enough to cope with this treatment
- You have satisfactory
lung function testresults – you can check this with your doctor
- You have satisfactory blood test results
- You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- You are willing to follow the study teams instructions and come to hospital for all study appointments
- You are willing to use reliable contraception during the study and for at least 90 days (for men) or 6 months (for women) after treatment
- You are at least 18 years old
- Your original (primary) tumour is greater than 2cm across (for people in group D of the study only)
You cannot enter this study if
- You have small cell lung cancer mixed in with your non small cell lung cancer
- You have had any other cancer which your doctor thinks may affect the study treatment or results
- You are still having side effects from any chemotherapy – if you still have hair loss you can still take part
- You have had radiotherapy already
- You have had experimental medicine as part of a clinical trial
- You have a condition that would affect how well the study drug is absorbed in your body, for example severe vomiting or diarrhoea
- You have had any bleeding disorder
- You get breathless walking 100 yards or less
- You have diabetes that is poorly controlled
- You have
inflammationin the tissues and space around the air sacs (alveoli) in your lungs (interstitial pneumonitis)
- You have blood pressure that is greater than 160mmHg systolic, or 100mmHg diastolic – you can check this with your doctor
- You have had any heart condition that is a cause for concern in the last year
- You have an infection
- You have raised calcium levels in your blood
- You are sensitive to any ingredient of the study drug AZD6244
- You have had major surgery in the last 4 weeks that would stop you having the study treatment – if you have had a procedure to insert a central line or portacath you can still take part
- You have known cancer spread to your brain, or you have symptoms of cancer spread to your brain
- The study doctor for any reason thinks you would not be well enough to take part
This study will recruit up to 33 people. Everyone will take AZD6244, and have a course of radiotherapy every weekday for between 6 and 6½ weeks. You have the standard dose of radiotherapy.
You will join one of 4 groups in this study. The group you join depends on when you enter the study.
The first people will join group B. If people in group B don’t have any severe side effects, the next people to enter will join group C, and have a higher dose. But if group B had severe side effects, the next people will join group A, and have a lower dose.
The study team will look for the largest dose that people can cope with, and that has side effects they can manage easily. They will choose this dose to study more. This is called the preferred dose.
15 people entering the study after the preferred dose has been chosen will join group D, and take AZD6244 at this dose.
If you are in group D, you will have 3 extra PET scans called FLT PET scans. These measure the change in growth rate of cancer cells during treatment.
You swallow AZD6244 capsules whole with a glass of water, 1 or 2 hours before radiotherapy. You should not eat anything for 2 hours before each dose, or for an hour afterwards. You take AZD6244 once or twice a day, depending on the group you are in. You start taking AZD6244 one week before your radiotherapy, and take it daily until you finish radiotherapy.
As well as taking your study medication, you will have regular tests and check ups to see how you are getting on.
The team will also ask if you would be willing to give them
- 2 research blood samples for the study
- The sample of tissue (biopsy) you had removed when you were diagnosed
They will look for features (biomarkers) in these samples, and in the FLT scan results, for information that may one day help doctors predict response,
Before you start the study you will see the doctor and have some tests. These tests include
- A physical examination
- Blood test
Heart trace (ECG)
- Heart ultrasound (
echocardiogram) - you will need to go to the Alexandra Hospital in Cheadle, Cheshire for this
- Eye test (you will need to go to the Alexandra Hospital in Cheadle for this)
- Chest X-ray
- CT scan of your chest and upper tummy area
- Scan to plan your radiotherapy
- Lung function test
You see the study doctor in the week before you start radiotherapy, have a chest X-ray and collect your medication. You then see the study team and give some blood samples
- Every week while you have radiotherapy and for the next 4 weeks
- Every 2 weeks until 3 months
- Every 3 months until 2 years
At the follow up visits after you finish radiotherapy, you will give more blood samples, have a chest X-ray, and an ECG if needed.
You will also have another heart ultrasound, regular CT scans and lung function tests. The team will tell you more about the timings of these.
You may have extra tests during the study if the team think you need them.
People in group D will have their FLT PET scans
- Before starting AZD6244
- One week after starting AZD6244
- During the first 2 weeks of having AZD6244 with radiotherapy
Each scan will last up to 65 minutes.
This is the first time people have taken AZD6244 with radiotherapy. So there may be some side effects the team do not know about. This is one of the reasons for the study.
Common side effects of AZD6244 on its own have included
- Swelling of the face and arms or legs
- Felling and being sick
- Shortness of breath
- Increase in blood pressure
- Blurred vision
- Increases in the salt levels in your blood, which may need treatment
- Short term changes to the way your liver works
- Loss of appetite
You should make sure that you use sunscreen while you are taking AZD6244 as the drug may make you more sensitive to sunlight. Your study team will talk to you more about side effects of AZD6244.
You can find out more about side effects of radiotherapy to the chest.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Corinne Faivre-Finn
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
The Christie NHS Foundation Trust
University of Manchester