A trial looking at MK-2870 for non small cell lung cancer that has spread
Cancer type:
Status:
Phase:
This trial is comparing chemotherapy with MK-2870 for non small cell lung cancer (NSCLC).
It is for people whose cancer has certain gene changes (
- the cancer has spread into nearby tissues and it isn't possible to treat it with surgery or radiotherapy or
- the cancer has spread to another part of the body
More about this trial
Non small cell lung cancer that has spread is
Doctors are looking at ways to improve treatment for NSCLC that has spread. In this trial they are looking at a new drug called MK-2870.
MK-2870 is a type of drug called an
- a
monoclonal antibody drug - a chemotherapy drug called KL610023
MK-2870 finds a protein called TROP2 on the cancer cells. It attaches itself to the protein. It then releases the KL610023 chemotherapy into the cancer cell. This kills or damages the cancer cell.
In this trial some people have docetaxel or pemetrexed chemotherapy. And some have MK-2870.
The main aims of the trial are to find out:
- how safe it is to have MK-2870
- which treatment works better
- what the side effects are
- 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
locally advanced NSCLC that can’t be removed with surgery or you can’t have radiotherapy with the aim to cure or you have cancer that has spread to another part of the body - have certain gene changes in the EGFR gene in your lung cancer cells or changes in certain other genes. These include ROS1, BRAF V600E, NTRK or MET. Your doctor will check this.
- have had certain treatment if you have a change in the EGFR gene called 19del or exon 21 in your lung cancer cells. This includes having at least 2
courses of treatment with a targeted cancer drug called atyrosine kinase inhibitor and treatment that included aplatinum drug . Your doctor checks if you have these gene changes and which treatments you’ve had in the past. - have had certain treatment if you have other gene changes in the lung cancer cells. This treatment includes having at least 2 courses of a tyrosine kinase inhibitor and treatment that included a platinum drug. Your doctor checks if you have these gene changes and which treatments you’ve had in the past.
- have lung cancer that got worse during or after your last treatment
- have cancer that your doctor can measure on a scan
- have a sample of tissue (
biopsy ) available that the trial team can use to do some tests on or you are willing to have a new sample taken - have satisfactory blood test results
- are willing to use reliable contraception during the trial and for a time after if there is any chance you or your partner could become pregnant
- are willing not to donate sperm during the trial and for a period after
- are willing not to donate eggs to others or to freeze or store eggs if you join this trial
- are fit and active 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 cancer that has spread to the brain or spinal cord or the thin tissue layers that cover them. You can take part if you had treatment, the cancer is stable and you stopped taking steroids.
- have non small cell lung cancer that is mainly made up of
squamous cells - have a mixture of small cell and non small cell cancer cells
- have had treatment with a drug that works in the same way as MK-2870
- have an EGFR gene change called T790M and you haven’t had a drug called osimertinib or a similar drug
- have had radiotherapy to help with symptoms within a week of starting trial treatment. Any side effects from radiotherapy must be better and you can’t be taking steroids.
- have had radiotherapy to the lung that was more than 30Gy within 6 months of the first dose of trial treatment. Your doctor will know this.
- have had another cancer treatment within 4 weeks of being put into a trial treatment group. Or it hasn’t cleared from your body yet .
- have another cancer that is getting worse or needed treatment in the last 3 years. You can take part if you had successfully treated
basal cell skin cancer ,squamous cell skin cancer orearly cancer of the bladder - are taking an experimental drug or using a device as part of another clinical trial. This is if it is within 28 days of being put in a treatment group for this trial.
- have moderate to severe side effects from past cancer treatments. This doesn’t apply if you have hair loss or white patches on your skin.
Medical conditions
You cannot join this trial if any of these apply. You:
- have or had inflammation of the bowel and you are taking medication to damp down the
immune system - have moderate to severe numbness or tingling in your hands or feet (peripheral neuropathy)
- have severe dry eyes, inflammation of the eyelids or a problem with the covering of your eye (cornea)
- have had a heart attack in the last 6 months or a significant
heart problem that needs treatment. The trial team check if you have a heart condition before you join the trial. - have had a
stroke in the last 6 months - take medication that affects substances in the body called CYP enzymes within 2 weeks of starting trial treatment. Your doctor can tell you more about this.
- have or had scarring on the lungs or active inflammation of the lungs (
pneumonitis ) and you needed to havesteroid treatment - have HIV unless you are having treatment and it is under control. You can’t take part if you have HIV and you developed an illness that occurs more often and is more severe in people with HIV.
- have active hepatitis B or hepatitis C unless you have had or are having treatment and it is under control or you have another active infection that needs treatment to the whole body
- have had major surgery and you aren’t better yet
- have any other medical condition or mental health problem that could affect you taking part
Other
You cannot join this trial if any of these apply. You:
- are allergic to MK-2870, anything it contains or any of the other treatments in the trial
- have had a
live vaccine within 30 days of the start of treatment. Please note that the approved COVID-19 vaccines are allowed as they aren’t a live vaccine. - have a problem with drugs or alcohol
- are pregnant or breastfeeding
Trial design
This phase 3 trial is taking place worldwide. The team need 566 people to take part including 9 people from the UK.
It is a randomised trial. A computer puts you into a treatment group. Neither you nor your doctor will be able to decide which group you are in.
- MK-2870 (group 1)
- docetaxel or pemetrexed (group 2)
You have treatment as long as it is working and the side effects aren’t too bad. You stop treatment if your cancer gets worse. The trial doctor will talk to you about other treatment options.
MK-2870 (group 1)
You have MK-2870 as a drip into a vein. You have it once every 2 weeks. The treatment takes about an hour and a half each time. You need to stay at the hospital for an hour after this. This is so the team can monitor how you are. Each hospital visit takes about half a day.
Docetaxel or pemetrexed (group 2)
You have docetaxel or pemetrexed chemotherapy as a drip into a vein. You have this once every 3 weeks. It takes about an hour each time. You will be at the hpistal for about half a day.
Samples for research
The researchers might ask to take a tissue sample (
They plan to use the samples to:
- see how well the treatment is working
- look at
genes to understand more about NSCLC - look for substances called
biomarkers to help work out why treatment might work for some people and not for others
If there is any remaining blood from the samples taken the team will ask to store this away for future research. You do not have to agree to your blood samples being stored. You can still take part in the trial.
Quality of life
The trial team ask you to fill out a questionnaire:
- before you start treatment
- at set times during treatment
- at set times after treatment
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 some tests before you can take part. These include:
- blood tests
- urine tests
- a
physical examination - heart trace (ECG)
- heart scan (echocardiogram) or
MUGA scan - CT scan or MRI scan
- bone scan
The doctor asks about any other medical conditions you have, your general health and what medications you take. They also ask if you have or have had any side effects of treatment.
You have all your treatment at the hospital in the outpatient department. During treatment you see the doctor regularly. This is for blood tests and to see how you are.
Trial scans
You have a CT or MRI scan:
- every 6 weeks for the first year
- every 3 months after that
You stop having scans as part of the trial if your cancer gets worse.
Follow up visits
When you stop treatment, you see the trial team one month later for a check up.
The team then check how you are getting on every 6 weeks to 3 months. You might see them at a routine hospital appointment. Or they may call you or check your medical notes.
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.
MK-2870 is a new drug so we don’t know what all the side effects are. The most common side effects we know about so far include:
- a drop in the number of blood cells causing an increased risk of infection, tiredness, breathlessness, bruising or bleeding
- liver changes
- high levels of an enzyme which may show tissue injury or that there is an infection
- sore mouth or throat
- inflammation of the
digestive system - feeling or being sick
- skin rash
- hair loss
- high levels of sugar in the blood
- loss of appetite or weight loss
There is a risk that MK-2870 could cause an allergic reaction needing treatment. Symptoms of an allergic reaction include difficulty breathing, a fast pulse, fainting, sweating, tiredness, swelling of the face, lips, mouth, tongue or throat.
You have medication before each MK-2870 treatment. This is to help stop an allergic reaction. Your nurse keeps a close eye on you during treatment. They will treat any symptoms straight away.
Your doctor will talk to you about all the side effects of treatment. You will have a chance to ask them any questions you may have.
We have more information about:
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
Dr Adam Januszewski
Supported by
Merck Sharp & Dohme LLC
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040