A trial looking at afatinib for non small cell lung cancer (ABLE)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at a drug called afatinib before surgery for people with early stage non small cell lung cancer.
More about this trial
If it’s diagnosed early enough, doctors may treat non small cell lung cancer (NSCLC) with surgery. You may also have chemotherapy after your surgery. But there is a risk that your cancer could come back and researchers are looking for new treatments to try to stop this happening.
In this trial, they are looking at a drug called afatinib. It is a type of biological therapy that works by targeting a protein called epidermal growth factor receptor (EGFR).
The researchers want to see if having afatinib before surgery can help people with NSCLC.
The aims of the trial are to find out
- How your cancer cells change through treatment with afatinib
- If afatinib can shrink your tumour before surgery
- If the researchers can pick out particular genes and proteins linked to whether afatinib works well or not
- More about the side effects
Who can enter
You may be able to join this trial if all of the following apply
- You have non small cell cancer (NSCLC) that is stage 1 or stage 2 and can be completely removed with surgery
- Your cancer can be seen on a scan and measures at least 8mm across
- You can swallow tablets
- 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 at least 18 years old
- You are willing to use reliable contraception during treatment and for up to 1 month afterwards if there is any chance that you or your partner could become pregnant
You cannot join this trial if any of these apply
- Your
cancer sample (biopsy) 
shows that you have small cell lung cancer cells as well as non small cell lung cancer cells - You have a type of tumour called a pulmonary carcinoid tumour or a large cell carcinoma (your doctor can tell you more about this)
- Your scan shows that there is cancer in the
lymph nodes in the centre of your chest on the same side as the affected lung, or there is cancer in the lymph nodes just under where your windpipe branches off to each lung - You have had chemotherapy or radiotherapy for your NSCLC in the past
- You have had a type of biological therapy that specifically target cells with
EGF receptors in the past - You are taking medication such as clarithromycin or ciclosporin (your doctors can tell you more about this)
- You have had any other cancer apart from non melanoma skin cancer
- You have a lung condition called interstitial lung disease
- You have had problems with your
digestive system in the last 6 months that may interfere with how you absorb the trial drug - You have a serious heart problem
- You have high blood pressure that can’t be controlled with medication
- You are pregnant or breast feeding
- You are hepatitis B, hepatitis C or HIV positive
- You have diabetes that can’t be controlled with medication
- You use drugs or alcohol in a way that is cause for concern
- You are known to be allergic to afatinib or anything it contains
- You have a serious eye infection that you have had a for a long time and is not getting better with treatment
- You are having any other treatment as part of a clinical trial
- You have a blockage in the large vein that brings blood back to your heart (the superior vena cava)
- You have any other medical condition or mental health problem that the trial team think would affect you taking part in this trial
Trial design
This is a phase 2 trial. The researchers need 60 people to join the trial. Everybody taking part will have afatinib for a few weeks before having surgery.
Afatinib is a tablet that you take once a day on an empty stomach. It is important to take it at least 1 hour before eating or at least 3 hours afterwards. You must not eat grapefruit or drink grapefruit juice as it may affect the way your body absorbs the drug.
You take afatininb until the day of your surgery for lung cancer. You have afatinib for about a month in total.
The researchers will ask to take a sample of your cancer () before you start treatment. If you have already had a sample taken, the researchers can use the stored sample for their tests. They will compare this sample with a sample that is removed when you have your lung cancer surgery. This is to see if afatininb has helped to treat your lung cancer.
Hospital visits
You see the trial team and have some tests before you start treatment. The tests include
- A physical examination
- Heart trace (
ECG ) - Chest X-ray
- Blood tests
- Urine test
- CT scan and a PET-CT scan
You have a CT scan on the day you start taking afatinib (or a few days before). And then you have a PET-CT scan 2 weeks after that.
The trial team will see you a month after your surgery for a check up and a blood test. They will continue to check how you are when you have your routine appointments with your lung cancer doctor.
Side effects
The most common side effects of afatininb are
- Diarrhoea
- Skin rash
- Sore mouth
- Nail changes
- Tiredness (fatigue)
- Loss of appetite
- Feeling sick
We have more information about the side effects of afatinib.
Recruitment start:
Recruitment end:
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.
Chief Investigator
Dr Clive Mulatero
Supported by
Boehringer Ingelheim
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Leeds
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
