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 comparing erlotinib with docetaxel for squamous cell lung cancer that has got worse despite having a platinum chemotherapy drug (EMPHASIS)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Doctors may use chemotherapy for non small cell lung cancer that has spread outside the lung or to another part of the body and can’t be treated with surgery or radiotherapy. This usually includes a platinum drug such as cisplatin or carboplatin.
This type of chemotherapy can help people to live longer as well as relieving symptoms. But the cancer will usually start to grow again at some point. If this happens, you may have more chemotherapy or you may have biological therapy.
Docetaxel is a chemotherapy drug that doctors can use in this situation. Erlotinib is a type of biological therapy they may use. The aim of this trial is to see which of these drugs is best for people who have the squamous cell type of non small cell lung cancer.
As well as comparing the 2 drugs, the trial is also studying a test called Veristrat. This looks for certain proteins in your blood that may show how well your cancer is likely to respond to drugs like erlotinib. Everybody taking part in this trial has the test before starting treatment. By following their progress, the researchers will be able to see how well the test predicts response to treatment.
Who can enter
You may be able to enter this trial if
- You have non small lung cancer that is squamous cell type
- Your cancer has spread outside your lung (stage 3B) and can’t be cured with radiotherapy, or has spread to another part of your body (stage 4)
- You have cancer that can be measured on a scan
- Your cancer has got worse despite having chemotherapy with a
- You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- You have satisfactory blood test results
- You are at least 18 years old
- You are willing to use reliable contraception during the trial and for a year afterwards if there is any chance you or your partner could become pregnant
You cannot enter this trial you
- Have cancer that your doctors know has a change (a mutation) to a gene called EGFR
- Have cancer that has spread to your brain, unless it has been successfully treated and you haven’t taken steroids for at least 2 weeks
- Have already had docetaxel or a type of drug called a tyrosine kinase inhibitor that targets receptors for a protein called EGF – your doctor can advise you about this
- Have had any other cancer treatment or another experimental drug in the last 3 weeks
- Have had any other cancer in the last 5 years, apart from carcinoma in situ of the cervix, non melanoma skin cancer or very early (
carcinoma in situ) breast cancer that was successfully treated
- Are known to be very sensitive to either of the drugs in the trial (or any of their ingredients)
- Have any other medical condition or mental health problem that could affect you taking part
This phase 3 trial will recruit 500 people in Europe.
When you join, the trial team will take a blood sample for the Veristrat test. Neither you nor your doctor will know results of the test. You will then be put into 1 of 2 treatment groups at random. Neither you nor your doctor will be able to decide which group you are in.
- People in group A have erlotinib tablets every day
- People in group B have docetaxel through a drip into a vein once every 3 weeks
As long as you don’t have bad side effects you can carry on having treatment until your cancer starts to get worse.
You see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests
- CT scan
If your doctor thinks your cancer may have spread to your brain, you will also have a CT or MRI scan of your brain.
During treatment, you go to hospital every 3 weeks. You have regular blood tests. You have a CT scan every 6 weeks
When you finish treatment, you see the trial team between 4 and 7 weeks later. You have a physical examination, more blood tests and a CT scan.
If you stop the trial treatment for any reason other than your cancer getting worse, you will see the trial team every 6 weeks until your cancer does start to get worse.
The trial team will then check how you are every 3 months. This may be at a hospital appointment or by phone.
The most common side effects of erlotinib include
- Feeling or being sick
- Skin problems including a rash, itching or dryness
- Sore eyes
- Loss of appetite and weight loss
- Changed sensation or numbness in your hands and feet
- Breathing problems or cough
- Sore mouth
- Tummy pain, indigestion or wind
- Changes to the way your liver works
- Tiredness (fatigue)
- High temperature (fever) or chills
Docetaxel can cause a reaction when you have the drug which may include flushing, rash, itching, chest tightness, breathing problems, high temperature, back pain and low blood pressure. Other common side effects of docetaxel include
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Loss of appetite, weight loss or weight gain
- Problems sleeping
- Numbness and tingling in your hands and feet (peripheral neuropathy)
- Aching joints or muscles and back pain
- Taste changes
- Swelling (inflammation) of your eyes, nose or throat
- Fluid retention
- Sore mouth
- Tummy (abdominal) pain and stomach upsets or indigestion
- Hair loss
- Redness and swelling on the palms of your hands or soles of your feet
- Changes to your nails
- Tiredness or flu like symptoms
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.
European Thoracic Oncology Platform (ETOP)
National Institute for Health Research Cancer Research Network (NCRN)