A trial to see if a body protein called ERCC1 affects how people with advanced non small cell lung cancer respond to different types of chemotherapy

Who can enter

You can enter this trial if

• You have been diagnosed with non small cell lung cancer that is stage 3B or stage 4
• There is a sample of cancer cells or tissue available from when you had a biopsy that can be tested for levels of ERCC1
• You are well enough to take part in the trial (performance status 0 or 1)
• You have satisfactory blood test results
• You are willing to use reliable contraception during the trial and for at least 6 months 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 you

• Have cancer that has spread to your brain unless this has been successfully treated and has not got any worse in the last month
• Have had radiotherapy unless it was radiotherapy for symptoms
• Have had another cancer apart from non melanoma skin cancer or carcinoma in situ of the cervix, or any other type of cancer if you haven’t had any sign of the disease for at least 3 years
• Take aspirin or other non steroidal anti inflammatory drugs (NSAIDs) and there is a reason you cannot stop taking them (you should not stop taking medication without talking to your doctor)
• Have a build up of fluid in the lungs (a pleural effusion) or fluid in the abdomen (ascites) that cannot be controlled
• Have another medical condition that the trial doctors think could affect you taking part
• Have had a yellow fever vaccination in the last month
• Are pregnant or breastfeeding

Trial design

The trial will recruit about 1,300 people. If you agree to take part, the trial doctor will get a small sample of the cancer cells or tissue removed when you had a biopsy, and send it to a central laboratory. The sample will be tested to see how much ERCC1 it contains. If the laboratory is not able to measure this, you will not be able to continue in the trial.

Once the doctor knows that the level of ERCC1 has been measured, you will be put into a treatment group at random. Neither you nor your doctor can decide which group you are in. This is called randomisation.

For people who have a type of NSCLC called squamous cell cancer, there are 2 possible treatments which are

• Cisplatin and gemcitabine
• Paclitaxel and gemcitabine

For people who have other types of NSCLC, the 2 possible treatments are

• Cisplatin and pemetrexed
• Paclitaxel and pemetrexed

People having pemetrexed also take folic acid tablets each day and have vitamin B12 injections every 9 weeks during treatment. Both of these help to reduce some of the side effects.

You have the chemotherapy drugs through a drip into a vein once every 3 weeks. This will take a few hours each time. Each 3 week period is called a cycle of treatment. You have up to 6 cycles of treatment.

You will be asked to fill out a questionnaire when you join the trial, each time you have chemotherapy, at the end of treatment and then 6 months, a year, 18 months and 2 years after starting treatment. The questionnaires will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.

The doctors will ask to take an extra blood sample and to keep a small sample of the tissue from your biopsy. The researchers will look at the DNA in these samples. This is to see if anything in your genes can help them to understand more about lung cancer and how different people respond to chemotherapy. The samples will only be used for research into cancer and will be kept for no longer than 15 years.

Hospital visits

You see the trial doctors and have some tests before you start treatment. The tests include

• Physical examination
• Chest X-ray
• CT scan
• Blood tests

You may need to stay in hospital overnight the first time you have chemotherapy. But after that, you can probably have chemotherapy as an outpatient. You have blood tests before each chemotherapy treatment. You have a CT scan after every 2 cycles of treatment. And you have a chest X-ray after every other cycle.

After you finish treatment, you see the trial doctors every month for a year and every 2 months after that. You will have a chest X-ray each time.

Side effects

The side effects of chemotherapy include

• Tiredness (fatigue)
• Feeling or being sick
• Sore mouth
• Taste changes and loss of appetite
• Allergic reactions
• Change to your skin and nails
• A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
• Constipation or diarrhoea
• Numbness or tingling in your hands or feet (peripheral neuropathy)
• Change to your kidneys, heart or liver
• Changes in your hearing
• Hair loss
• Aching joints or muscles
• Headaches or abdominal pain
• Changes in your blood pressure
• Flu like symptoms

If you have gemcitabine, you may have some temporary swelling of your face, hands or feet. There is more information about the side effects of cisplatin, paclitaxel, gemcitabine and pemetrexed on CancerHelp UK.