A trial of chemotherapy and durvalumab for non small cell lung cancer (MERMAID-1)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at adding durvalumab to chemotherapy after surgery to remove non small cell lung cancer (NSCLC).
It is also looking at measuring small amounts of cancer cells that may be in the bloodstream after surgery.
It is for people who have stage 2 or stage 3 NSCLC. That is early stage cancer or cancer that has grown into nearby tissues or 
.
More about this trial
Surgery is a common treatment for non small cell lung cancer. Sometimes there are tiny amounts of cancer cells in the blood after surgery. This is called minimal residual disease or MRD.
The cancer might come back if these cancer cells start to grow again. So doctors want to improve treatment for people who have MRD after surgery. They think that giving additional treatment will work. They hope this will delay or stop the cancer starting to grow again. But they aren’t sure so want to find out more.
is a usual treatment option after surgery for NSCLC. In this trial researchers are looking at adding a drug called durvalumab.
Durvalumab is an . It stimulates the body's to fight cancer cells.
In this trial you have surgery as planned. The team test for MRD in the tissue removed and in blood tests. Depending on the results you might have treatment as a part of the trial. This is either chemotherapy and durvalumab or chemotherapy and a .
The main aims of the trial are to find out:
- if detecting MRD after surgery for NSCLC means there is a higher risk of the cancer coming back
- if durvalumab in combination with chemotherapy is safe
- if adding durvalumab to chemotherapy reduces the risk of the cancer coming back in people who have MRD
- more about the side effects of the combination of treatment
- how treatment affects
quality of life
Who can enter
The following bullet points are a summary of 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:
- have early stage non small cell lung cancer (stage 2 cancer) or it is possible to remove the cancer completely with surgery (stage 3 cancer)
- have had a
CT scan or MRI scan of the chest to help plan your surgery - give a blood sample before surgery for the team to look at your genetic make up (
DNA ) - are at least 18 years old
As well as the above, to have trial treatment, the following must also apply:
- you have a CT scan within 28 days of surgery and 7 days before going into a treatment group
- your surgeon can collect samples of cancer during surgery for the trial team to run some tests on. This includes looking at the genetic make up of the cancer.
- it is possible for the trial team to measure if you have MRD in the blood or not after surgery
- your wound heals completely after surgery. And if you have side effects from past treatment these are also better. This is apart from hair loss.
- you are suitable to have 4
cycles of chemotherapy that includes a platinum drug after surgery - you weigh more than 30kg
- you are willing to use reliable contraception during the trial and for a period after if there is any chance you or your partner could become pregnant
- you are fit and active but might not be able to do heavy physical work (performance status of 0 or 1)
Who can’t take part
You cannot join this trial if any of these apply.
Cancer related
You:
- are having a type of surgery called a
wedge resection and can’t have another type of surgery - have had scans results or the tissue biopsy result after surgery that shows your cancer has come back
- need to have more surgery to remove the lung cancer or it isn’t possible to remove your lung cancer with surgery in the first place
- have a mix of small cell and non small cell lung cancer. Your doctor will know this.
- have already had treatment after surgery for lung cancer or you have had durvalumab in the past
- have changes in
genes called EGFR and or ALK in your lung cancer cells - are having chemotherapy, an experimental treatment, a
targeted drug or hormone treatment for cancer - have had or are having radiotherapy for NSCLC after surgery to more than 30% of the
bone marrow or you had radiotherapy to a large area within 4 weeks of the first dose of treatment in this trial - have had another cancer that has got worse or needed treatment in the past 5 years unless it has a low chance of coming back. You can join if it was successfully treated
non melanoma skin cancer , carcinoma in situ (CIS) or very early melanoma skin cancer.
Medical conditions
You cannot join this trial if any of these apply. You:
- have an
autoimmune condition that needs treatment apart from certain ones. Your doctor will know about this. - have a
heart problem that isn’t well controlled with medication. The trial team check if you have a heart condition before you join the trial. - have had treatment that damps down the
immune system . This includes steroids within 2 weeks of starting trial treatments unless it was a low dose. - have a problem with how your immune system works
- have a lung condition called interstitial lung disease
- have a serious problem with your
digestive system such as Crohn's disease or ulcerative colitis - have had an
organ transplant or a bone marrow transplant with someone else’s cells - have had a whole
blood transfusion within 120 days of giving the tissue sample looking at the genetic changes - have HIV, an active hepatitis B or hepatitis C infection, active tuberculosis (TB) or any severe infection that needs treatment
- have another medical condition or mental health problem that your doctor or the trial team think could affect you taking part
Other
You cannot join this trial if any of these apply. You:
- have never smoked or you have smoked less than 100 cigarettes in your life
- are allergic to any of the treatments in the trial or anything they contain
- can’t have platinum chemotherapy for any reason
- have had a
live vaccine within 30 days of the start of treatment. Please note that the COVID-19 vaccine is allowed as it isn’t a live vaccine.
Trial design
This phase 3 trial is taking place worldwide. The trial team invite 2,225 people to take part.
The trial involves:
- testing for minimal residual disease (MRD) and then
- some people having trial treatment
Please note, you can only have the treatment in this trial if the team know your MRD status. And if all of the other entry conditions apply.
Collecting blood and cancer samples
The team ask for blood samples when you join the trial before surgery. They also ask your permission to get a sample of your cancer when you have surgery to remove it. They analyse these samples. They look at your genetic make up () and at the make up of the cancer. This information helps them to check for minimal residual disease after surgery.
Surgery
Everyone has surgery as planned. This is part of your routine care. Your doctor can tell you more about the type of surgery you will have. They can also tell you how long you’ll be in hospital for and how long it will take to get better.
Minimal residual disease (MRD) blood test
After surgery you have a blood test. The team do this test about 3 to 5 weeks after surgery. The test they are using is new. It aims to detect any cancer cells in the blood. This is called circulating tumour DNA or .
To have trial treatment the team need to know if you:
- have cancer cells present after surgery. This means you are MRD positive.
- have no cancer cells after surgery. This means you are MRD negative.
Trial treatment
The team need about 332 people to have the treatment in this trial. This includes:
- 232 people who are MRD positive
- 100 people who are MRD negative
The treatment part is randomised. There are 2 treatment groups. You are put into a group by a computer. Neither you nor your doctor will be able to decide which group you are in. Nor will they know which group you are in. Your doctor can find this out if necessary.
You are put into a treatment group between 9 and 12 weeks of having surgery.
You have 1 of the following:
- chemotherapy and durvalumab
- chemotherapy and a dummy drug
You have 1 of the following combinations of chemotherapy.
You have chemotherapy as a drip into a vein. The combination of chemotherapy you have depends on the hospital where you are having your treatment. You have up to of chemotherapy. You have this once every 3 weeks. This takes about 12 weeks.
You have durvalumab or the dummy drug as a drip into a vein. You start it when you begin chemotherapy. You have it
- once every 3 weeks for 4 cycles of treatment and then
- once a month for 10 months
It takes about 60 minutes each time. You have this for up to 14 months in total.
Samples for research
The trial team will ask you to give some extra blood samples. Where possible you have these at the same time as your routine samples.
They will ask to look at samples of cancer from your surgery. They might ask you to give a new sample if your cancer gets worse.
The researchers plan to look at:
- substances called
biomarkers to help work out why treatment might work for some people and not for others tumour markers genes to learn more about lung cancer
Quality of life
The trial team ask you to fill out a questionnaire:
- before you start treatment and
- at set times during treatment
You do this on a smart phone or device. The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.
Hospital visits
You see the doctor and have tests before you can take part in this trial. These include:
You have treatment at the hospital on the day care ward. You see the doctor regularly during treatment for a check up and blood tests.
You have a CT or MRI scan every 3 months for up to 5 years. You stop the scans if your cancer gets worse. You doctor will talk to you about other treatment options.
Follow up
You see the trial doctor within:
- a month of your last dose of treatment and
- 12 weeks of your last dose of treatment
After that you see them every 3 months for a check up for up to 5 years. These visits stop if your cancer comes back.
Side effects
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.
| Durvalumab can affect the immune system. It may cause inflammation in different parts of the body. This can cause serious side effects. They could happen during treatment, or some months after treatment has finished. Rarely, these side effects could be life threatening. If you have any of these side effects tell your doctor or nurse as soon as possible. You should tell them that you are on or have been on an immunotherapy. |
The most common side effects of durvalumab are:
- diarrhoea
- skin rash or dry, itchy skin
- tummy (abdominal) pain
- a sore throat, runny or stuffy nose – due to an upper respiratory tract infection
- a cough
- high temperatures (fever)
- your
thyroid not making enough hormones. Symptoms may include tiredness, weight gain, feeling the cold more, constipation, muscle weakness, slow heart rate, puffy face, dry skin, thinning hair and memory problems.
The trial doctor will talk to you about all the possible side effects of treatment. You’ll have a chance to ask any questions you may have.
We have more information about:
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 Gary Middleton
Supported by
AstraZeneca
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
