A trial looking at pembrolizumab with or without V940 for non small cell lung cancer (INTerpath-009)
Cancer type:
Status:
Phase:
This trial is looking at pembrolizumab with or without an 
drug called V940 for non small cell lung cancer.
It is open to people whose cancer can be removed with surgery.
More about this trial
After your surgery to remove the non small cell lung cancer, your doctor might treat you with pembrolizumab. The aim of this treatment is to reduce the risk of the cancer coming back. Research has shown that it is a useful treatment for people in this situation. Doctors are looking for ways to further improve treatment.
Pembrolizumab is an immunotherapy. It works by helping the to find and kill cancer cells.
V940 is an immunotherapy. It is a therapy that is made in the laboratory from found in the cells of your cancer. V940 works by helping the immune system to find and kill cancer cells.
Researchers think that combining V940 with pembrolizumab might work better than pembrolizumab on its own. In this trial half the people will have pembrolizumab and V940. And the other half will have pembrolizumab and a dummy drug ().
The aims of the trial are to find out:
- how well the combination of pembrolizumab and V940 works and if it is better than pembrolizumab by itself
- how safe the combination is
- more about the side effects of this combination
- how the combination 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.
| The entry conditions below apply to everyone who might be able to take part. There may be other entry conditions that need to apply for you to continue in the trial. Your doctor or a member of the trial team will be able to tell you about these. |
You may be able to join this trial if all of the following apply. You:
- have non small cell lung cancer (NSCLC) that is stage 2, stage 3A or stage 3B and can be removed by surgery
- have not had treatment for your NSCLC. This is apart from having pembrolizumab with chemotherapy before you had surgery to remove the cancer. Your doctor can tell you more about this.
- have satisfactory blood test results
- are willing to use reliable contraception during the treatment and for a period of time after if there is any chance you or your partner could become pregnant. You must also agree not to store eggs or sperm while in the trial.
- are able to look after yourself but might not be able to do heavy physical work (performance status 0 or 1)
- are at least 18 years old
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
- have a type of lung cancer that is a small cell lung cancer, NSCLC mixed with small cell lung cancer, a neuroendocrine cancer with large cells, sarcomatoid carcinoma or a Pancoast tumour
- have NSCLC that has a change (
mutation ) in the EGF receptor (EGFR positive ), and you can have treatment with a targeted drug - have cancer that has changes in the ALK
gene . Your doctor will know this. - have already had treatment with an
immunotherapy drug. Your doctor will know this. - have had
systemic treatment for cancer apart from certain ones that your doctor will know about - have had treatment with a cancer vaccine
- have had radiotherapy within the 2 weeks before starting the trial treatment or you have ongoing side effects from radiotherapy, and you need to take
steroids - have had an experimental drug or used a device as part of another clinical trial within the 4 weeks before starting the trial treatment
- have ongoing side effects from previous treatment. This is apart from certain ones which your doctor will know about.
- have another cancer that has got worse or needed treatment in the past 5 years. This is apart from successfully treated
non melanoma skin cancer , any carcinoma in situ (CIS) except bladder CIS, or early prostate cancer.
Medical conditions
You cannot join this trial if any of these apply. You:
- have an immune system that isn’t working well or you are taking medication that affects how well the immune system works within the week before starting trial treatment. This is apart from a small dose of steroids. Your doctor will know the dose.
- have an
autoimmune disease apart from certain ones that your doctor will know - have inflammation or scarring of the lungs, or you needed steroids in the past to treat this
- have HIV that is not stable and controlled by medication. Or if you have had Kaposi’s sarcoma, Multicentric Castleman’s disease or both.
- have hepatitis B or hepatitis C. You can join if you have had medication for them and there is no sign of them.
- have any other active infection that needs systemic treatment such as antibiotics
- have not recovered from surgery or you have ongoing complications from surgery
- have had a stem cell or bone marrow transplant from a donor (
allogeneic transplant ) - have had an
organ transplant - have any other medical condition, a mental health condition or any other circumstances that could affect you taking part in the trial
Other
You cannot join this trial if any of these apply. You:
- are allergic or sensitive to any of the treatments used in the trial
- have a
live vaccine within the 30 days before starting the trial treatment. The COVID-19 and seasonal flu vaccines, apart from the nasal spray FluMist, are not live vaccines. - are pregnant of breastfeeding
Trial design
This is an international phase 3 trial. The team need 680 people worldwide to take part including about 46 people from the UK.
You can join the trial either before you have surgery or after you have had surgery to remove the NSCLC.
Joining before having surgery
You have before surgery. This is pembrolizumab and chemotherapy. Your doctor will decide which chemotherapy is best for your NSCLC. You have one of the following combinations:
- cisplatin and pemetrexed
- carboplatin and pemetrexed
- cisplatin and paclitaxel
- carboplatin and paclitaxel
- cisplatin and gemcitabine
- carboplatin and gemcitabine
You have pembrolizumab and the chemotherapy as a drip into a vein. You have treatment in cycles. Each is 3 weeks. Your doctor will explain how often you have each drug and how many cycles of treatment you have.
You then have surgery as planned. You might have radiotherapy after surgery. Your doctor will tell you if you need radiotherapy and give you more information about it.
There might be a reason why you cannot continue in the trial. Your doctor will tell you if this is so and discuss with you what comes next.
If you are able to continue in the trial, you go into a trial treatment group.
Joining after surgery
You go into a trial treatment group.
Trial treatment groups
This is a randomised trial. A computer puts you into 1 of 2 groups. Neither you nor your doctor can choose which group you go into. Neither will you nor your doctor know which group you are in. This is a double blind trial.
Your doctor will be able to find out which treatment group you are in if this is necessary.
The 2 treatment groups are:
- V940 and pembrolizumab
- a dummy drug (placebo) and pembrolizumab
V940
You have V940 as an injection into a muscle, such as the upper arm, thigh or buttocks. You have V940 every 3 weeks. Each 3 week period is a cycle of treatment. You have up to 9 cycles of V940 as long as it is helping and the side effects are not too bad.
V940 is made in the laboratory using genes taken from your cancer cells. Your V940 is made just for you. In the laboratory certain genes with changes () are selected to make V940. To get the genes from the cancer cells, the researchers use a piece of the cancer tissue that was removed when you had surgery. They will also use a sample of your blood. They will make it as fast as possible. But it might take between 6 and 8 weeks from when you join the trial.
It may not be possible to make V940 for some people. In this situation, you will not be randomised to the trial. You will have pembrolizumab on its own.
Dummy drug (placebo)
You have the dummy drug as an injection in the same way you have V940.
Pembrolizumab
You have pembrolizumab as a drip into a vein. You have it every 6 weeks. Each 6 weeks is a cycle of treatment.
You can have 7 cycles of treatment as long as it is helping and the side effects aren’t too bad.
Quality of life
People in both groups fill in questionnaires:
- before starting treatment
- during treatment
- after treatment
The questions ask about:
- your general health and wellbeing
- what daily activities you can do
- side effects
These are called quality of life questionnaires.
Samples for research
The team ask everyone for a piece of tissue from the cancer that was removed when you had your operation. You also have a blood test. They use these samples to look for substances () that might tell them:
- more about the cancer
- how well treatments work
- why some treatments work better than others
- why some treatments work better for some people
The team will ask for a fresh sample of tissue () if your cancer comes back during the trial. You do not have to agree to have this biopsy taken. You can still take part in the trial.
Hospital visits
You see the doctor for a and tests before you take part in the trial. The tests might include:
- blood tests
- a scan such as a PET scan, a CT scan or an MRI scan
- heart trace (ECG)
You see the doctor regularly during treatment. This is to see how you are and for tests.
Follow up
Everyone sees the doctor a month after finishing treatment. This is to see how you are.
If you completed treatment, you see the doctor every:
- 12 weeks for a year
- then every 24 weeks up to year 3
- then every 48 weeks
If you stop treatment because a scan shows your cancer has come back, the team will contact you every 12 weeks to check on your health.
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.
Your doctor will talk to you about the possible side effects of the treatments used in the trial and will answer any questions you may have.
V940 is a new drug and there may be side effects we don’t know about yet.
The side effects of V940 we know about are:
- pain, redness, itching, warmth and swelling at the site of the injection
- high temperature (fever)
- tiredness (fatigue)
- shivering
- flu-like symptoms
- headache
- muscle and joint pain
- feeling sick
You might have an allergic reaction to V940. Symptoms include:
- changes in blood pressure
- difficulty breathing
- hives
The healthcare team will watch you closely when you have V940 and for a while after, to make sure you are okay. If you have an allergic reaction, they will give you medication to help.
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Pembrolizumab can affect the These side effects could happen during treatment or months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for. |
We have information about the side effects of:
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 Sanjaykumar Popat
Supported by
Merck Sharp & Dohme LLC
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
