A study to learn more about non small cell lung cancer (TRACERx)

Coronavirus and cancer

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Coronavirus and cancer

We know it’s a worrying time for people with cancer, we have information to help. If you have symptoms of cancer contact your doctor.

Read our information about coronavirus and cancer

Cancer type:

Lung cancer
Non small cell lung cancer

Status:

Open

Phase:

Other

This study is looking at non small cell lung cancer to see how it changes over time. The study is supported by Cancer Research UK.

More about this trial

Cancer varies between different people. Even in an individual patient, the cancer can change over time. In this study, researchers will take samples of blood and cancer tissue at different times over a 5 year period. They will look at them in the laboratory to help them understand which changes affect the way a cancer grows.

The aim of the study is to look at features of non small cell lung cancer, including genetic Open a glossary item factors to see how they change over time. The study team also hope to see why some lung cancers are difficult to treat.

Taking part in this study will not affect the treatment you have and there may be no direct benefit to you.

Who can enter

You may be able to join this study if you

  • Have non small cell lung cancer (NSCLC) that hasn’t spread beyond one side of your chest (stage 1A to stage 3A). Your cancer must be at least 15mm in size
  • Are going to have surgery to remove your lung cancer
  • Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • Agree to have follow up appointments at a specialist centre involved in the trial
  • Are at least 18 years old

Some people joining the study may not have had a definite diagnosis of NSCLC, but from looking at scans, their doctors think it very likely that they have it. They can join the study, but if tissue removed during surgery shows they don’t have NSCLC, they will not continue in the study.

You can’t join the study before having surgery if

  • After looking at scans, your surgeon doesn't think they will be able to remove enough tissue needed for the study
  • You have chemotherapy before your surgery
  • You have had any other cancer in the last 5 years apart from carcinoma in situ of the cervix, non melanoma skin cancer or very early stage melanoma (stage 0, carcinoma in situ)
  • You have HIV, hepatitis B, hepatitis C or syphilis

And you may not be able to continue in the study after you’ve had surgery if

  • Your surgeon is not able to remove all the cancer, or they find you have a different type of cancer
  • There is not enough cancer tissue left for the study after routine tests are carried out
  • You have chemotherapy that doesn’t include a platinum drug Open a glossary item

Trial design

The study aims to recruit 842 people. The study team will take blood samples when you join the trial. They will also ask your permission to get a sample of your cancer that will be removed during surgery.

The study team may ask to take a blood sample from a blood vessel in your lungs during surgery. This is called pulmonary blood sampling. You will have this done while you are under anaesthetic so won’t be aware of it. If you agree to this, they will ask you to sign a separate consent form Open a glossary item.

After surgery, your specialist will let you know if you need to have chemotherapy. Taking part in the study does not affect this.

The study team will ask your permission to get more blood samples and possibly samples of your cancer over a 5 year period.

The blood samples can usually be taken when you are having other blood tests as part of your routine treatment and follow up. But the study team will ask you to give extra blood samples if your cancer comes back, and if it then gets worse. They will also ask for blood samples when you have finished any further treatment you have.

The study team will ask for a sample of your cancer if it comes back or spreads to another part of your body. They will get this when you have a biopsy Open a glossary item or surgery to remove the cancer. They will ask you to sign a separate consent form each time.

Having a biopsy involves removing part of the tumour from the lung, or from the area of the body where it has spread to, such as the lymph nodes Open a glossary item, liver or bone. You may have a local or general anaesthetic Open a glossary item.

While looking at a CT scan or an ultrasound scan, the doctor puts a needle through your skin into the tumour and removes a sample. Or they may remove a sample of cancer from the lung by passing a flexible tube called a scope into your mouth and down into the upper part of your lungs.

The study team may ask you to have a biopsy more than once. For example, if your cancer gets worse and your doctor changes your treatment. This may help them to understand why a certain treatment did not work for you. And they may be able to use the information from the biopsy to see if there is an appropriate drug for your particular cancer being looked at in a clinical trial Open a glossary item that you might be able to take part in.

Results so far

In late 2019 and May 2020 some groups of researchers published some early results for TRACERx.

They plan to publish more results once the trial has finished and they have analysed all the information.

In October 2019, the researchers published some early results.

One group of researchers looked at blood samples from the first 100 people who joined TRACERx . They looked at circulating tumour cells (PV-CTCs). These are tumour cells that have broken away from the lung cancer and are circulating in the blood. They found the cancer was more likely to come back in people who had high numbers of PV-CTCs in their blood at the time of surgery than those with lower PV-CTC numbers. 

Another group of researchers looked at a new way to predict how well people do after treatment for lung cancer.  They developed a test called ORACLE. It identified people who were at high risk of the cancer coming back that current tests weren’t picking up on. They plan to look at this in more detail as it might help doctors and people with lung cancer to make decisions about whether chemotherapy should be part of their treatment.

A third research group looked at lung T cells. They are a type of white blood cell Open a glossary item important in attacking and killing tumour cells. The trial team looked at tumour samples (biopsies Open a glossary item) and found a unique set of T cells that were recognising and fighting the cancer. The same T cells were detected in the blood at the time of the operation to remove the tumour. The researchers think that this might mean that they could develop a blood test which would be able to tell how well treatment is working. This raises the possibility of a blood test which can reliably tell us how well a treatment is working for an individual patient.

This research also suggests that specific groups of T cells from patients could be found and used as part of their treatment. 

In May 2020, another group of researchers published results. They used a computer programme or artificial intelligence (AI) tool. The aim of the tool was to find out which people have a higher chance of their lung cancer coming back. 

The researchers looked at samples of tissue (biopsies Open a glossary item) from 100 people who had taken part in the TRACERx trial. Computer scientists and specialist doctors called pathologists trained the AI tool. This meant the tool was able to pick out immune cells from cancer cells. Immune cells are important as they can find and kill cancer cells. 

The tool mapped out areas in the cancer where the number of immune cells were high. This was in comparison with the number of cancer cells. This helped researchers to build a detailed picture of the lung cancer. And how it changes to respond to the immune system in individual people.

Using the AI tool, the team found that some parts of the cancer were packed with immune cells. They called these ‘hot’ regions. And other parts of the cancer didn’t have any or many immune cells at all. They called these ‘cold’ regions. The researchers suggest that areas of the cancer with fewer immune cells had developed ways to hide from the immune system.

The researchers looked at the people who had a higher number of ‘cold’ regions. They found that they were at a higher risk of their cancer starting to grow again (relapse). The AI tool can count how many areas there are that can hide from the immune system. 

This research is in its early stages. But the researchers suggest that in the future it might give doctors more detailed information about the make up of the cancer. This might help them to work out the best treatment for each person.

We plan to update this page as the research team produce more results.

Hospital visits

When you join the study, you see the team and have some tests including

The study team will assess your general health and they will ask you to fill out a questionnaire about your lifestyle and whether or not you are (or have been) a smoker.

They will take extra blood samples when you have routine blood tests every 3 months for the first 2 years, then every 6 months for the next 3 years.

They will talk to you about having a biopsy Open a glossary item of your cancer if it comes back in your lungs or spreads elsewhere in your body. After this they will ask you to visit the hospital every 3 months.

Side effects

The risks associated with having a biopsy depend on where in your body the doctor takes the biopsy from. Your doctor will talk to you about this at the time and ask you to sign a separate consent form Open a glossary item.

Location

Aberdeen
Barnet
Birmingham
Cardiff
Chertsey
Clydebank
Glasgow
Harlow
Leicester
Liverpool
London
Manchester
Sheffield
Southampton

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Charles Swanton

Supported by

Academy for Medical Sciences
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Rosetrees Trust
University College London (UCL)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

11176

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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