A trial looking at a new biological therapy for advanced non small cell lung cancer (TOPICAL trial)

Who can enter

You can enter this trial if you

• Have stage 3b or 4non small cell lung cancer (NSCLC)
• Have either been diagnosed within the last 2 months and have not had treatment, OR you have had surgery or radiotherapy in the past and your cancer has started to grow again within the last 2 months
• Are not able to have chemotherapy, radiotherapy or surgery to treat your lung cancer
• Have satisfactory blood test results
• Are able to take tablets
• Are prepared to use adequate contraception while you are taking part in the trial
• Are over 18

You cannot enter this trial if you

• Have had treatment with a tyrosine kinase inhibitor in the past
• Have had chemotherapy in the past
• Have had radiotherapy for symptom control (unless it was to your bones and in the last 2 weeks)
• Are currently being treated with a COX 2 inhibitor
• Have symptoms caused by cancer that has spread to your brain
• Have any other serious medical condition
• Are pregnant or breast feeding

Trial design

This is a randomised trial. It will recruit 664 patients into 2 groups. The people taking part are put into a treatment group by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither will you or your doctor know which group you are in. This is called a 'double blind' trial.

If you are in group 1, you will have erlotinib (Tarceva). If you are in group 2, you will have a dummy tablet (placebo).

You will take either the placebo or the Tarceva tablet once a day for up to 2 years. If it is working very well, your doctor may decide that you can carry on taking it after that.

You will be asked to fill out a questionnaire

• Before you start treatment
• Once a month for the first year (12 months)
• After 1 and a half years (18 months)
• After 2 years (24 months)

This will ask you how you have been feeling and about any side effects you have had. It is called a Quality of Life questionnaire.

Hospital visits

You will have some tests done at the hospital before you can take part in this trial. These include

• Chest X-ray
• Blood tests
• CT scan
• Physical examination
• Possibly a bone scan

You will see the trial doctors once a month for the first year and once every 2 months after that. Each time you see them you will have a chest X-ray and a physical examination. You will have a CT scan after 3 and 6 months.

Side effects

As with all treatments, erlotinib (Tarceva) does have some side effects. But it is a new drug, so doctors may not know about all of the side effects yet. Those they know about so far include

• Skin problems such as a rash, dry skin or spots
• Diarrhoea
• Feeling or being sick
• Dry eyes
• Dry mouth
• Tiredness
• Headache
• Mouth (oral) pain

A very small number of people have had lung or liver problems while taking Tarceva. If you have had liver problems in the past, the trial team will do regular blood tests to check your liver function.

If you have bad side effects, your doctors may decide to give you a lower dose. Or you may stop treatment for a couple of weeks, and then start again.