A trial comparing dacomitinib and erlotinib for advanced non small cell lung cancer (ARCHER)

You may be able to enter this trial if you

• Have non small cell lung cancer that has spread to another part of your body
• Have cancer that can be measured on a scan
• Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
• Have satisfactory blood test results
• Are willing to use reliable contraception during treatment and for 3 months afterwards if there is any chance you or your partner could become pregnant
• Are at least 18 years old

You cannot enter this trial if you

• Have cancer that has spread to your brain – you may take part if you have had treatment, have had no symptoms and stopped taking steroids at least 2 weeks before you would be put into your treatment group
• Have had more than 2 treatments for your advanced lung cancer
• Have already had a drug called an EGF blocker, such as gefetinib, lapatinib, cetuximab, trastuzumab, panitumumab, cantertinib, neratinib, matuzumab, Tovok and pertuzumab - you can ask your doctor
• Have had any treatment for your advanced lung cancer in the past 2 weeks
• Are having treatment as part of another clinical trial
• Have had any serious heart problem in the past 6 to 12 months
• Have high blood pressure that is not controlled with medication
• Have had another cancer in the past 3 years apart from non melanoma skin cancer, in situ carcinoma of the cervix or prostate cancer that had not spread outside the prostate and has been successfully treated
• Have had another medical condition that could affect you taking part in this trial
• Are taking medication that affects the way erlotinib works in your body – you can ask your doctor about this
• Have any problems with your digestive system that affects how you absorb tablets

This is an international phase 3 trial. It will recruit at least 800 people from different countries around the world. The trial is randomised. The people taking part are put into 1 of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. Neither of you will know which group you are in. This is called a double blind trial.

The 2 groups are

• Erlotinib and a dummy drug (placebo)
• Dacomitinib and a dummy drug

You take your medication daily by mouth with a glass of water. You continue treatment as long as it is helping you and the side effects are not too bad.

You have a diary to write down when you take your medication, how much you take and any information about side effects.

You fill out 2 questionnaires when you start treatment and then several times in the first 2 weeks of treatment. After that, you complete them

• Monthly during treatment
• At the end of treatment
• A month after stopping treatment

The questionnaires will ask about side effects and how you’ve been feeling. This is a quality of life study.

If you agree to take part in this trial, the researchers will ask for extra blood samples. They will also ask for an extra tissue sample if your doctor thinks your cancer has started to grow again. If you don’t want to agree to either or both of these you don’t have to. You can still take part in the trial.

You see the doctor to have some tests before taking part in this trial. These tests include

• A physical examination
• Blood tests
• Urine test
• Heart trace (ECG)
• Heart scan (MUGA or ECHO)
• CT scan or MRI scan

In the first 2 weeks of treatment you see the doctor several times to have your skin examined. You then see the doctor every month for

• A physical examination
• Blood test
• Urine test
• Skin examination

You also have a

• Heart trace monthly for 2 months, then every 3 months
• Heart scan 3 monthly for 6 months, then every 6 months
• CT scan or MRI scan monthly for 4 months, then every 2 months

After treatment you see the doctor, or the researchers will telephone you, every 2 months.

The side effects of dacomitinib may include

• Diarrhoea
• Rash, dry, itchy, cracked skin
• Sore or dry mouth
• Sore throat
• Feeling or being sick (nausea)
• Tiredness (fatigue)
• Sore nails
• Loss of appetite and taste changes
• Sore, red palms of the hand or soles of the feet
• Sore, red or dry eyes
• Hair loss or growth

The common side effects of erlotinib include

• Rash, dry, red, itchy skin
• Diarrhoea
• Loss of appetite
• Tiredness (fatigue)
• Feeling or being sick (nausea)
• Sore red or dry eyes
• Sore mouth

Your doctor will talk to you about other possible side effects before you agree to take part in this trial.

We have more information about erlotinib in our cancer drugs section.