A trial looking at erlotinib after treatment for non small cell lung cancer (RADIANT)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Lung cancer

Non small cell lung cancer

Status:

Closed

Phase:

Phase 3

This trial is comparing erlotinib (Tarceva) to a placebo (dummy drug) after surgery, and possibly chemotherapy, for non small cell lung cancer (NSCLC).

Doctors treat NSCLC that has not spread with surgery, if possible. Depending on the situation, they may suggest having chemotherapy afterwards to help lower the risk of cancer coming back. But not everyone has chemotherapy. Unfortunately the cancer may begin to grow again after treatment.

Doctors think that giving erlotinib after surgery, and possibly chemotherapy, may mean the cancer is less likely to come back. But they are not sure yet.

Erlotinib is a tyrosine kinase inhibitor (TKI). It works by blocking receptors on the surface of cells called 'epidermal growth factor receptors' (EGFR). Doctors hope that by blocking these receptors, they will be able to stop or slow down the growth of cancer cells.

Not all lung cancers have EGFR, so the researchers will need to test a sample of your cancer from when you had your surgery. You can only take part in this study if your cancer has EGFR.

The main aims of this study are to

Find out if erlotinib after surgery alone, or after surgery and chemotherapy, will lower the risk of non small cell lung cancer coming back
Learn more about the side effects of erlotinib

Who can enter

You can enter this trial if you

Have stage 1b, 2 or 3a non small cell lung cancer, unless it has spread to lymph nodes in the centre of your chest (N2 disease)
Have had surgery to completely remove your cancer (unless you had a type of surgery called a wedge resection or segmentectomy)
May have had up to 4 cycles of chemotherapy after your surgery (which must have included a platinum drug, such as cisplatin or carboplatin) and you have recovered from any side effects
Had surgery within the last 6 months, if you had chemotherapy, OR had surgery within the last 3 months if you did not have chemotherapy
Your lung cancer cells have EGF receptors (the researchers will need to test a sample of your cancer that was removed during surgery)
Are able to take tablets
Are well enough to take part (performance status 0, 1 or 2)
Have satisfactory blood test results
Are prepared to use reliable contraception while you are taking part in the trial, and for at least 2 weeks afterwards, if there is any chance that you or your partner could become pregnant
Are at least 18 years old

You cannot enter this trial if

Your cancer is a mix of both small cell lung cancer and non small cell lung cancer, or you have a carcinoid tumour (your doctor can tell you about this)
You have had radiotherapy for your lung cancer
You had chemotherapy before surgery to remove your cancer
You have had a serious heart condition in the last year (such as uncontrolled high blood pressure or angina) or you need to take medication for an abnormal heart rhythm (arrhythmia)
You have a condition that makes it difficult for you to absorb tablets (such as Crohn’s disease or ulcerative colitis)
You have had any other cancer in the last 5 years apart from non melanoma skin cancer or carcinoma in situ of the cervix that has been successfully treated
You have any other medical condition that would make it difficult for you to take part
You have had treatment with a drug similar to erlotinib in the past (an EGFR inhibitor)
You are allergic to any of the drugs in this trial or any of their ingredients
You are taking part in another clinical trial at the same time
You are pregnant or breastfeeding

Trial design

This is a randomised trial. It will recruit 945 people into 2 groups. The people taking part are put into one of two treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in, or will be told which group you are in. This is common in clinical trials and is called a double blind trial.

Two out of every three people taking part will be in group 1 and have erlotinib. One out of every three people taking part will be in group 2 and have a placebo.

You will take either erlotinib or the placebo once a day for up to 2 years. Exactly how long you have the treatment for will depend on how well you are and whether your cancer comes back.

The researchers will ask if they can keep a sample of tissue from when you had surgery. They will use this to see if your cancer cells have EGF receptors. They would also like to use it for other tests to learn more about EGFR and similar biological markers Open a glossary item . In the future, this information may help doctors to tell in advance whether someone will benefit from taking erlotinib.

They will also ask for a sample of blood before you start treatment. Doctors know that people’s genes may affect how well some medicines work, but they need to learn more about this. If you do not wish to do this, you don’t have to. You can still take part in the trial.

Hospital visits

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

Physical examination
Blood tests
CT scan (if you didn’t have one before you joined the trial)
X-ray

You will see the doctors a month after you start treatment. You will then see them every 3 months for as long as you are taking erlotinib or the placebo. This could be up to two years. On each visit you will have a blood test and physical examination. You will also have either an X-ray or CT scan every 6 months.

You will see your doctor about a month after you have stopped taking the tablets and then once every 6 months for a further 3 years.