
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
This trial is to find the best dose of certain targeted drugs to give alongside radiotherapy for people with non small cell lung cancer (NSCLC).
It is for people whose lung cancer hasn’t spread further than the chest. This is called localised lung cancer.
Cancer Research UK supports this trial.
A combination of radiotherapy and chemotherapy is a usual treatment for people with NSCLC. This is called chemoradiotherapy. This isn’t suitable for everyone so you may have only radiotherapy.
Radiotherapy works by damaging the inside cancer cells, which could cause them to die. Certain drugs work by stopping cells from repairing damage to their DNA. These drugs are called DNA damage response inhibitors (DDRi). They make it more likely that a damaged cell will die. So researchers think that having a DDRi drug with radiotherapy might improve treatment.
In this trial, researchers are looking at 5 different DDRi cancer drugs. They would like to find out about how well these work with radiotherapy. But first they need to find the best dose of each to give alongside radiotherapy.
Some people have only radiotherapy. And some have radiotherapy and a DDRi. The drug you have depends on when you join the trial. There are 2 groups that are open at the moment. These are:
We’ll update the summary as more groups open.
The main aims of the trial are to:
Doctors hope to run a larger trial when they find the best dose to give.
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if all of the following apply.
You:
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
Medical conditions
You cannot join this trial if any of these apply. You:
Other
You cannot join this trial if you are pregnant or breastfeeding.
This is a phase 1 trial. The researchers hope to find 210 people to take part.
It is a randomised trial. You are put into 1 of 2 groups at random by a computer. Neither you nor your doctor can decide which group you are in. You have 1 of the following:
The type of DDRi you have depends on when you join the trial. About 50 to 60 of the 210 people taking part have radiotherapy only. The rest have radiotherapy and a DDRi.
For those having a DDRi, the first few people to take part have a low dose of the drug. If they don’t have any bad side effects the next few have a higher dose. And so on until they find the highest safe dose. This is a dose escalation study.
CONCORDE A
In Concorde A you have 1 of the following:
Olaparib is a tablet. The dose you have depends on when you join the trial. Your doctor tells you how often to take it.
You start taking it when you start radiotherapy and for the 6 weeks that you have radiotherapy.
CONCORDE B
In Concorde B you have 1 of the following:
AZD1390 is a tablet. You have it either:
or
You start AZD1390 on the same day as you start radiotherapy. You take it for 6 weeks. The dose you have depends on when you join the trial. The trial doctor can tell you more.
Radiotherapy
Everyone has radiotherapy as part of the trial. This is a You have it every week day, Monday to Friday. It takes about 15 minutes each time. You have radiotherapy for 6 weeks.
Quality of life
The team ask everybody taking part to fill out a questionnaire before starting treatment, at set times during the trial and after finishing treatment. The questionnaire asks about any side effects you have had and about how you have been feeling. This is called a quality of life study.
Samples for research
The trial team ask you to give some extra blood samples for research. You give these at the same time as your routine samples if possible.
They’ll also ask for a sample of your cancer that was removed when you had a .
Researchers plan to use the samples to look for biomarkers to see who benefits most from having a DDRi added to radiotherapy.
You see the doctor and have some tests before taking part. These tests include:
You have a check up every week during radiotherapy. When you finish radiotherapy you see the team:
You have a CT scan at:
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
AZD1390 is a new drug so there might be side effects we don’t know about yet. The common side effects we do know about include:
Some people with cancer in the brain who had AZD1390 developed:
Some short term side effects of radiotherapy include:
Some long term side effects of radiotherapy include:
We have more information about:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Alastair Greystoke
Prof Corinne Faivre-Finn
Cancer Research UK
AstraZeneca
Leeds Teaching Hospitals NHS Trust
Newcastle University
University of Glasgow
University of Leeds
University of Manchester
This is Cancer Research UK trial number CRUK/19/006.
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.