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 trial looking at MEDI4736 for non small cell lung cancer (ATLANTIC)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a new drug called MEDI4736 to treat non small cell lung cancer. The trial is for people with non small cell lung cancer (NSCLC) that has spread into the surrounding tissue or to another part of the body.
Doctors can treat non small cell lung cancer that has spread with
MEDI4736 is a type of biological therapy called a monoclonal antibody. It seeks out cancer cells by looking for a particular protein and attaching to it. The researchers think that by doing this, MEDI4736 may help your immune system to attack your cancer and stop it from growing.
The main aims of this trial are to find out
- How well MEDI4736 works to treat non small cell lung cancer
- What happens to MEDI4736 in your body
- If MEDI4736 helps your immune system to attack the cancer
Who can enter
You may be able to join this trial if all of the following apply
- You have non small cell lung cancer that has spread into lymph nodes on the other side of your chest, or into other surrounding tissues (stage 3b), or has spread to another part of your body (stage 4), or has come back after (or during) treatment
- You have had a
platinum chemotherapy drugand at least 1 other treatment that reached your whole body ( systemic treatment)
- Your cancer produces a certain amount of a substance called PD L1 (the trial team will test a sample of your cancer tissue for this)
- Your last treatment finished at least 3 weeks ago if it was a tyrosine kinase inhibitor, or at least 2 weeks ago if it was chemotherapy (if you had drugs called
nitrosoureasor mitomycin C, you must have finished treatment 6 weeks ago)
- You have at least 1 area of cancer that can be measured on a scan
- You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- You have satisfactory blood test results
- You are willing to use reliable contraception if there is any possibility that you or your partner could become pregnant
- You are at least 18 years old
For the first few people taking part in the trial, your cancer cells must have a change to genes called EGFR or ALK and you have had treatment with a drug called a tyrosine kinase inhibitor (your doctor can tell you this).
You cannot join this trial if any of these apply. You
- Have cancer that is a mixture of small cell lung cancer and non small cell lung cancer
- Have cancer that has spread to your brain or is pressing on your spinal cord (spinal cord compression), unless you have had treatment, you don’t have symptoms and you haven’t taken steroids or drugs to prevent fits (anticonvulsants) for at least a month
- Are having any other anti cancer treatment
- Have already had an anti PD 1 or anti PD L1 antibody (the trial team can advise you about this)
radiotherapyin the 4 weeks before starting MEDI4736, or within 2 weeks if it is radiotherapy to a small area for pain relief
- Have had radiotherapy to your lungs
- Have had an organ transplant
- Have had major surgery in the last month
- Still have any moderate to severe side effects from earlier treatment, or mild side effects from
- Had a severe allergic reaction to immunotherapy
- Have had another cancer in the last 5 years apart successfully treated
early cancersor any other cancer that has been treated with the aim to cure and there hasn’t been any sign of it for at least 5 years
- Take medication that dampens down your
immune systemapart from nasal sprays, inhalers or a low dose of steroids (10 mg or less a day)
- Have had an
autoimmune diseaseapart from vitiligo, Grave’s disease or psoriasis that hasn’t needed systemic treatmentin the past 2 years
- Have (or had) inflammatory bowel disease such as Crohn’s disease or ulcerative colitis
- Have HIV or any other disease that affects your immune system
- Have certain heart problems (the trial team can advise you about this)
- Have hepatitis B or hepatitis C
- Have (or had) tuberculosis
- Are going to have a
live vaccinationwithin a month of taking part in the trial
- Are allergic to MEDI4736 or anything it contains
- Have any other medical condition or mental health problem that the trial team thinks could affect you taking part in the trial
- Are pregnant or breastfeeding
This is an international phase 2 trial. The trial team need 282 people to join.
Everybody taking part will have MEDI4736. You have MEDI4736 as a drip into a vein every 2 weeks. It takes an hour each time. After your 1st treatment, you need to stay in hospital to be monitored for about 3 hours. If all goes well, you are monitored for an hour after all your other treatments. As long as MEDI4736 is helping you and the side effects aren’t too bad you have treatment for a year.
The researchers will take blood samples to look for substances called
The researchers will also ask you take part in a genetic sub study. For this they will take blood samples to look at the genes in your blood cells. Genes are coded messages that tell cells how to behave. Sometimes genes have changes (mutations) that can affect how cells behave and respond to treatment. The team want to find out if they can identify whose cancer may respond better to MEDI4736.
You can’t take part in the genetic sub study if you have had a
You don’t have to take part in this sub study, you can still take part in the main trial.
You see the doctor to have some tests before taking part in this trial. These tests include
During treatment you see the doctor for a physical examination and blood tests every 2 weeks for the first 2 months and then every 4 weeks. You have a heart trace and a CT scan or MRI scan every 2 months.
A month after your last treatment you see the doctor for
- A physical examination
- Heart trace
- Blood tests
If the treatment worked after you finish, you see the doctor to have a physical examination and blood tests
- Every month for 4 months
- Every 2 months for the rest of the first year
- Then every 6 months
You have a CT scan or MRI scan every 3 months until your cancer gets worse. If you stopped treatment because of side effects you have a scan every 2 months for a year and then every 3 months.
If your cancer got worse during treatment you see the doctor for a physical examination and blood tests every month for 3 months.
MEDI4736 is a new drug and there may be side effects we don’t know about yet. The most common side effects may include
- Tiredness (fatigue)
- Feeling or being sick
- Loss of appetite
- Skin rash, itchiness
- Change in blood pressure
- A drop in blood cells causing an increased risk of bruising or bleeding
- Difficulty breathing
You may have an allergic reaction to MEDI4736. While having it, you will be closely monitored. You may also have a reaction hours or days after having the drug. The trial team will tell you what to look for and what to do if this happens.
The trial team will talk to you about all the possible side effects before you agree to take part in the trial.
How to join a clinical trial
Professor Peter Schmid
NIHR Clinical Research Network: Cancer