A trial of talactoferrin for advanced non small cell lung cancer (FORTIS-M)

Please note this trial is no longer recruiting patients.

This trial is looking at a new drug called talactoferrin for non small cell lung cancer that has got worse despite treatment.

Doctors can treat non small cell lung cancer with surgery, radiotherapy, chemotherapy or biological therapy. But this type of cancer often comes back after treatment and researchers are looking for new treatments to help people in this situation.

In this trial, they are looking at a drug called talactoferrin. Talactoferrin is made in the laboratory, but is similar to a body substance called lactoferrin. Lactoferrin is normally found in white blood cells and in liquids made in the body (secretions) such as breast milk, saliva and tears. Lactoferrin can help the body fight infections and reduce swelling (inflammation). It may also help the immune system to kill lung cancer cells.

The aim of this trial is to see if having talactoferrin helps people with non small cell lung cancer that has got worse despite already having 2 other types of treatment.

Recruitment

Start 01/06/2009

End 02/03/2011

Phase

Phase 3

Who can enter

You can enter this trial if you

Have non small cell lung cancer that is stage 3B or stage 4
Have already had 2 different types of treatment that reach the whole body (systemic treatments), and at least one of them included a platinum drug for advanced lung cancer, but your cancer has continued to grow
Have at least 1 area of cancer that has not been treated with radiotherapy and can be seen on a scan
Have satisfactory blood test results
Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
Are willing to use a reliable form of contraception during the trial and for a month 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, unless this was treated with radiotherapy more than 4 weeks ago, has not got worse since, is not causing symptoms, and you haven’t had steroids to control the symptoms in the last 3 weeks
Have had radiotherapy in the last 4 weeks
Have had any other systemic treatment for cancer, steroids or an experimental drug in the last 4 weeks
Have had an allergic reaction to anything that is similar to talactoferrin
Can’t take medicine by mouth for any reason
Have had any other type of cancer apart from carcinoma in situ of the cervix, prostate cancer or superficial bladder cancer that have been successfully treated, non melanoma skin cancer, or any other solid tumour that has been treated if you have been free of disease for more than 5 years
Have heart disease or heart failure that cannot be controlled with medication
Have a serious infection or another serious medical condition that cannot be controlled with medication and the trial doctors think it could affect you taking part
Are known to be HIV, hepatitis B or hepatitis C positive
Are pregnant or breastfeeding

Trial design

This is a phase 3 trial. It will recruit more than 700 people around the world. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And you will not know which group you are in. This is called a double blind trial.

Everybody taking part in the trial will have all treatment that is available to help any cancer symptoms and side effects and to improve their quality of life. Researchers usually call this ‘best supportive care’. As well as best supportive care,

People in group 1 have talactoferrin liquid to swallow
People in group 2 have a dummy liquid (placebo) to swallow

You drink the liquid twice a day for 12 weeks, then have 2 weeks without any treatment. Each 14 week period is called a cycle of treatment. You take the 2 doses of liquid about 12 hours apart, half an hour before food, or an hour afterwards. You have up to 5 cycles of treatment, which takes more than a year. But you will stop the trial treatment if your lung cancer gets worse, or if you decide that you no longer want to take part – you do not have to give a reason.

Hospital visits

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

Physical examination
Blood tests
Heart trace (ECG)
CT scan or MRI scan

You have regular hospital visits during the trial, and have a blood test each time. You have a CT or MRI scan

After 7 weeks of treatment
Then every 14 weeks until you finish the trial treatment

If the doctors can see that the growth of your cancer has slowed down, or the cancer has got smaller, they will ask you to have more CT scans to see how long the effect lasts.

If you stop having treatment for any reason other than your cancer getting worse, you will have a CT or MRI scan within a month of finishing treatment.

Everybody will see the doctors within a week of finishing treatment and again after a month. A member of the trial team will contact you by phone once a month to check how you are for at least a year after you start the trial treatment.