A study to learn more about lung cancer and mesothelioma of the lung (TRACERx EVO)
Cancer type:
Status:
Phase:
This study is collecting tissue, blood and other samples from people who have lung cancer or mesothelioma of the lung.
It is for people who have one of the following:
- small cell lung cancer
- non small cell lung cancer
- mesothelioma of the lung
Cancer Research UK supports this trial.
More about this trial
Researchers want to learn more about small cell lung cancer, non small cell lung cancer and mesothelioma of the lungs. Mesothelioma is a type of cancer that can develop in the covering of the lungs. This is also called pleural mesothelioma.
We know that lung cancer and pleural mesothelioma can come back and spread. How this happens varies between different people. Even in one person, the cancer can change over time. Researchers want to learn more about this. To do this they are looking at tissue, blood and other samples. They plan to look at the make up of the cancer at various time points. They also plan to look at normal tissue samples.
This will help them to understand:
- the way a cancer grows
- how best to treat lung cancer and mesothelioma of the lung
- why some patients lose weight and muscle mass when diagnosed with cancer
There are 3 groups in this study:
- people who have stage 1 to stage 3 non small cell lung cancer and are due to have surgery (group A)
- people who have non small cell lung cancer that can’t be treated with surgery, it has spread into surrounding tissues or to another part of the body (group B)
- people who have small cell lung cancer or mesothelioma of the lung (group C)
The researchers have already done a trial called TRACERx. It also collected samples from people with lung cancer. Researchers hope this study will build on what they learnt about cancer in the TRACERx trial.
The main aims of this study are to:
- look at the make up of each person’s cancer
- learn more about the features of lung cancer and pleural mesothelioma
- find out how lung cancer and pleural mesothelioma changes over time
This is an 
. This means that taking part will not affect the
treatment you would normally get. You might not benefit directly from taking part in this study. It might help doctors to improve treatment for lung cancer and pleural mesothelioma treatment in the future.
Who can enter
The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
Who can take part
To join group A all of the following must apply. You:
- have non small cell lung cancer that hasn’t spread beyond one side of your chest. This is stage 1 to stage 3 non small cell lung cancer (NSCLC).
- are suitable to have surgery to remove all the cancer. This might also include treatment before surgery to help shrink it.
- have cancer that measures at least 15mm across if you don’t have any treatment before surgery
- have a sample of tissue from a previous
biopsy that the study team can look at for those having treatment before surgery - are well enough to have surgery and treatment before surgery if you have this
Some people joining group A may not have had a definite diagnosis of NSCLC, but from looking at scans, their doctors think it very likely that they have it. You can join the study, but if tissue removed during surgery shows you don’t have NSCLC, you won’t continue in the study.
To join group B all of the following must apply. You:
- have stage 3 NSCLC that can’t be treated with surgery, you have stage 1 to stage 3 cancer that can be treated with surgery but you didn't have this or you have newly diagnosed cancer that has spread to other parts of the body
- are suitable for cancer treatment
- have a sample of cancer tissue taken at a previous biopsy that the team can access
To join group C all of the following must apply. You:
- have small cell lung cancer or pleural mesothelioma. You can take part if you have NSCLC that has changed to small cell lung cancer.
- have a sample of cancer tissue that was taken at a previous biopsy that the team can access
- are fit enough for cancer treatment
As well as the entry conditions for each group, the following must also apply for all groups. You:
- are willing to attend the follow up visits
- are up and about for at least half the day but might not be able to work (performance status 0, 1 or 2)
- are at least 18 years old
Who can’t take part
You cannot join this study if any of these apply. You:
- have another cancer or cancer that has come back in the last 3 years. You can take part if you have
non melanoma skin cancer , early melanoma skin cancer, or in situ cancer of the cervix. You might be able to take part if you have another cancer that came back more than 2 years ago but less than 3. This is only if you have NSCLC. The study team check if you have had another type of cancer before you join the study. - have another cancer that was diagnosed or has come back at any time and you are having treatment for this
- have another medical condition or mental health condition that means you can’t give
informed consent to take part - have HIV, hepatitis B, hepatitis C, syphilis, tuberculosis (TB) or Creutzfeldt-Jacob (CJD) disease
As well as the above, you can’t join group A if any of the following apply. You:
- have cancer that hasn’t been completely removed with surgery
- haven’t had enough tissue samples taken
- don’t have
invasive cancer following surgery. Your doctor will know this.
As well as the above, you can’t join cohort B or C if there isn’t enough of a tissue sample available when you join the study.
Trial design
The team need up to 600 people to take part. This includes:
- 300 people in group A
- 200 people in group B
- 50 to 100 people in group C
Samples for all three groups
The team will ask to collect tissue samples. This is when you join the study, during surgery if you have this or from routine samples. The team will also ask for a piece of tissue from any previous tissue samples taken.
The tissue samples include cancer tissue and normal tissue. These are from the lung, and a small sample of muscle tissue.
The team also ask to take some extra blood samples. Where possible, you have these taken at the same time as your routine blood tests.
The team plan to use the samples to look at:
genes - changes in the cancer
circulating tumour DNA
They also ask to collect some other samples. These include:
- spit (saliva)
- sputum if you have a productive cough
- samples of cells if you have a
bronchoscopy as part of your routine care - poo
- a sample of tissue from inside your nose
You have the samples taken:
- when you join the study or before surgery if you have this
- at surgery (if you have this)
- during chemotherapy, radiotherapy or other treatment if you have this
- at each follow up appointment
- if your cancer comes back or gets worse
- if you develop a new lung cancer that isn’t related to your original diagnosis
The team will tell you exactly which samples you have taken at each time point. This depends on the group you are in.
The team will also ask your permission to store some samples for future research. You don’t have to agree to this.
More samples and assessments
You may be asked to complete some other assessments. These include:
- a cortisol measurement. Cortisol is a natural steroid hormone that affects the level of sugar in the blood. You use an at home kit to swab the inside of your mouth to provide the measurement.
- a check to see how your muscles work. This is a 30 second arm curl and a sit stand test.
- an activity measurement. You wear a wristband for 7 to 10 days to monitor your daily activity.
- an energy assessment
- heart checks
Energy assessment
This involves drinking some fluid and giving a very small urine sample every day for 10 days. You post the samples to the laboratory. The team will give you self addressed envelopes.
You can say no to this assessment if you don’t want to. It won’t affect you taking part in the study.
Heart checks
You:
- have an MRI scan of your chest
- do a 6 minute step exercise assessment
- do a 6 minute walk with an activity monitor
You have these heart assessments and tests done:
- when you join the study
- at 3 months
- at 6 months
You can say no to the heart checks if you don’t want to do them. It won’t affect you taking part in the rest of the study.
Questionnaires
The trial team ask you to fill out some questionnaires:
- when you join the study
- at set times during the study
The questionnaires ask about side effects and how you’ve been feeling. This is called a quality of life study.
Hospital visits
You shouldn’t have any extra hospital visits if you join this study. The team will arrange for the samples to be taken at your routine hospital appointments. You might have a few extra hospital visits if you have the extra heart checks done.
After any treatment, you have follow up appointments as part of your routine care. Your doctor will tell you how often you have these.
After this, the team continue to follow you up by checking your medical notes and .
Side effects
You might have discomfort or bruising from the blood samples.
Taking a is a safe procedure. You may have some discomfort, bruising and slight bleeding.
Location
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.
Chief Investigator
Professor Charles Swanton
Supported by
Cancer Research UK
University College London (UCL)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
