A study to find and treat pre cancerous changes in the lungs (TIDAL1)

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

Cancer type:

Lung cancer

Status:

Closed

Phase:

Pilot

This is a study to find out how many people at high risk of getting lung cancer have abnormal cells in the lining of their lungs, and whether a drug called gefitinib could stop these turning into cancer.

For some diseases, it is possible to test people who are at high risk to see if there are early signs before it develops or causes symptoms. This is called screening. Before screening for any type of cancer can be carried out, doctors must have an accurate test to use. At present, there is no screening programme for lung cancer.

Researchers want to find ways of screening groups of people who are at high risk of getting lung cancer.

More about this trial

This study is looking at a type of bronchoscopy called an autofluorescence bronchoscopy. A bronchoscopy means having a tube put down your windpipe and into the main airways of your lungs. An autofluorescence bronchoscopy uses a special type of light to examine the inside of your lungs.

This test can help doctors find abnormal areas in the lining of your lungs and take samples (biopsies). In these abnormal areas, there are changes to the cells. This is called dysplasia. If the cells look very different to normal cells, it is called high grade dysplasia.

Some of these abnormal areas will stay the same, or go back to normal. But over time, some of them can change into lung cancer. Doctors don’t fully understand why some of these areas become cancer and some do not. And they don’t know the best thing to do if they find abnormal cells.

Researchers think that a drug called gefitinib may stop dysplasia turning into lung cancer. Gefitinib (also known as Iressa) is a type of biological therapy called a tyrosine kinase inhibitor. It is already used to treat lung cancer, but has not been used to treat pre cancerous changes before.

People who have had treatment for non small cell lung cancer or a type of head and neck cancer called squamous cell cancer Open a glossary item are known to be at high risk of getting a new lung cancer. It is people in this situation who are taking part in this study.

The main aim of the study is to see if it is possible to work out the proportion of people in this high risk group who have areas of high grade dysplasia in their lungs.

If the researchers find that they can do this, they will plan larger studies to learn more about how dysplasia turns into lung cancer and whether it is possible to successfully treat the cell changes before this happens. The researchers also want to see what effect gefitinib has on high grade dysplasia.

Who can enter

You may be able to enter this trial if you

Have had surgery to cure non small cell lung cancer or have had successful treatment for squamous cell cancer of the head or neck
Finished all your treatment (including chemotherapy and radiotherapy) at least 3 months ago
Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
Are able to have a bronchoscopy
Have satisfactory blood test results
Are willing to use reliable contraception if you take gefitinib and there is any chance you or your partner could become pregnant – you would need to carry on using contraception for 4 weeks after you finish taking gefitinib
Are at least 18 years old

You cannot enter this study if you

Have had another type of cancer in the last 5 years apart from non melanoma skin cancer or carcinoma in situ of the cervix that has been successfully treated with no signs of the cancer coming back for at least a year
Have already had a drug that blocks a cell receptor called EGFR
Have had another experimental drug as part of a clinical trial in the last 3 months
Are known to be very sensitive to gefitinib or any of its ingredients
Have ever had a lung condition called interstitial lung disease
Have scarring in your lungs (pulmonary fibrosis), or your lungs are not working very well (poor lung function)
Had inflammation of your lungs after radiotherapy (pneumonitis ) and you needed steroids to treat it
Cannot swallow tablets or have problems with your digestive system that could affect how you absorb the tablets
Take other medication that can affect an enzyme in your body called CYP3A4
Have any other medical condition that the study team think would make it unsafe for you to take part
Are pregnant or breastfeeding

Trial design

This is a pilot study (feasibility study) that will recruit about 40 people. Everybody taking part will have an autofluorescence bronchoscopy. If the bronchoscopy shows any signs of cancer, you will not be able to carry on to the next part of the study. Your doctors will discuss your treatment options with you.

If the bronchoscopy shows that you don’t have any cell changes, or you have some changes but they are low grade, you leave the study at this point. You will continue to have your routine follow up.

If the bronchoscopy shows that you have very abnormal cells (high grade dysplasia), the study doctors will talk to you about taking gefitinib. You don’t have to carry on into this part of the study if you don’t want to.

Whether or not you agree to have gefitinib, the researchers will ask everybody with very abnormal cells to have another chest X-ray and autofluorescence bronchoscopy 6 months and a year later.

If you have very abnormal cells and agree to take gefitinib, you take it as tablets every day for 6 months.

Hospital visits

If you join the 1st part of the study, you see the study doctors and have some tests. The tests include

Physical examination
Blood tests
CT scan of your chest if you have not had one in the last 5 weeks

The study team may also ask you to have an ultrasound scan of your liver.

You then have an autofluorescence bronchoscopy. This takes about 30 minutes, but you have a sedative beforehand to make you sleepy. After the bronchoscopy, you stay at the hospital until you are fully awake. You can usually go home on the same day.

If the bronchoscopy shows that you have very abnormal cells, you can go into the 2nd part of the study.

If you go into the 2nd part of the study and you agree to take gefitinib, you start taking it within 3 weeks of having your bronchoscopy. You have hospital visits after 2 weeks, 1 month and 3 months of treatment. You have a physical examination and blood tests at each visit. You see the study team and have a chest X-ray and autofluorescence bronchoscopy after 6 months and 1 year.