A trial looking at immunotherapy for non small cell lung cancer (Galaxies Lung 201)
Cancer type:
Status:
Phase:
This trial is looking at dostarlimab by itself and with other immunotherapies. The other immunotherapies are belrestotug and GSK6097608.
It is open to people with non small cell lung cancer that has spread.
You pronounce belrestotug as bell-rest-oh-tug.
More about this trial
Some cancers including non small cell lung cancer (NSCLC) have proteins on their cells that stop the 
recognising and killing the cancer cells. Blocking these proteins can help the immune system recognise and kill cancer cells.
Dostarlimab is a monoclonal antibody, it works by blocking a protein called PD-L1 on cancer cells.
Belrestotug (GSK4428859A) is another monoclonal antibody that blocks a protein called TIGIT on cancer cells.
GSK6097608 is another monoclonal antibody that blocks a protein called CD96 on the cancer cells.
Research shows that a drug that blocks PD-L1 combined with a drug that blocks TIGIT might work better than one that blocks PD-L1 only. Or both these drugs combined with a drug that blocks CD96 might work better than either a PD-L1 by itself or in combination with one that blocks TIGIT.
In this trial the team are looking at:
- dostarlimab by itself
- dostarlimab with belrestotug
- dostarlimab, belrestotug and GSK60967608
To take part in the trial your NSCLC must have a high level of the PD-L1 protein. The team will test for this when you agree to take part. If your cancer doesn’t have enough of the PD-L1 protein, or none, your doctor will discuss other treatment options.
The aims of the trial are to find out:
- how well the combination of dostarlimab and belrestotug works
- what is the best dose of belrestotug to have with dostarlimab
- how well the combination of dostarlimab, belrestotug and GSK6097608 works
- what are the side effects of this combination
- how does it affect
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 non small cell lung cancer (NSCLC) that has spread into the nearby tissue (locally advanced) or has spread to another part of the body (metastatic). Your doctor can explain this.
- have a tissue sample (
biopsy ) from when you were diagnosed with NSCLC that has spread that the team can obtain. If this not available you must be willing to have a fresh biopsy taken. - have a high level of PD-L1 in the cancer cells. The team use the tissue biopsy to find this out.
- have an area of the cancer spread that the doctor can measure
- need to be up and about, can look after yourself but might not be able to do heavy physical work (performance status 0 or 1)
- have satisfactory blood test results
- are willing to use contraception during treatment and for a certain time after if there is any chance you or your partner could become pregnant
- 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 already had
systemic treatment such as chemotherapy for your cancer spread - have cancer with a change (
mutation ) in the EFGR, ALK genes or any other gene change that can be treated by a targeted drug . Your doctor will know this. - have already had treatment with a type of immunotherapy called a
checkpoint inhibitor . Your doctor will know this. - have cancer spread to the brain, spinal cord or the tissue surrounding the brain. This is unless it has been treated, it is stable for at least 2 weeks before
randomisation and you are not taking steroids for at least 3 days before randomisation. - have another cancer or had another cancer within the past 5 years unless it has been successfully treated and there has been no sign of it for at least 2 years. You can also join if you had a
non melanoma skin cancer or an in situ carcinoma that has been successfully treated. - have never smoked tobacco or you have smoked less than 100 tobacco cigarettes in a lifetime. Your doctor will know how to work this out.
Medical conditions
You cannot join this trial if any of these apply. You:
- have major surgery within 4 weeks of starting treatment
- have more than a certain dose of radiotherapy within 6 months of starting treatment. Your doctor will know what the dose is.
- have an
autoimmune disease or had one that needed systemic treatment in the past 2 years. This is apart from treatment that the body would have made such as insulin for diabetes and thyroxine for thyroid problems. Your doctor will know about this. - have steroid treatment that reaches your whole body within 3 days of starting treatment. This is apart from creams, inhalers, eye drops and other steroids treatments that your doctor will know about.
- are having medication that damps down the
immune system . Your doctor will know about this. - have certain
lung problems . Your doctor will know which these are. - have certain
problems with the digestive system . Your doctor will know which these are. - have fluid on the abdomen (ascites) or fluid on the lung (pleural effusion) that is causing symptoms unless you have had treatment and it is stable
- have had certain
heart problems within the past 3 months. Your doctor will know which these are. - have certain
liver problems . Your doctor will know which these are. - have HIV, hepatitis B or hepatitis C. You have any other severe infection that needs treating within 4 weeks of starting treatment.
- have any other medical condition, mental health problem or social situation that could affect you taking part in the trial.
Other
You cannot join this trial if any of these apply. You:
- are sensitive or allergic to monoclonal antibodies or what they are made of
- have a
live vaccine within 30 days of starting treatment. COVID-19 vaccines and the seasonal flu vaccine are not live vaccines. - are pregnant or breastfeeding
Trial design
This an international phase 2 trial. The team need about 300 people worldwide to take part.
This is a randomised trial. A computer puts you into a treatment group. Neither you nor your doctor can choose which group you are in.
There are 4 groups in this trial.
The groups are:
- dostarlimab
- dostarlimab and a low dose of belrestotug
- dostarlimab and a medium dose of belrestotug
- dostarlimab, belrestotug and GSK6097608
You have dostarlimab, belrestotug and GSK6097608 as a drip into a vein. You have your treatment every 3 weeks. Each 3 week period is called a .
You can continue to have treatment as long as it is helping and the side effects aren’t too bad.
Samples for research
The team will ask for blood samples and poo (stool) samples. You might have some or all of these samples taken. Your doctor will tell you which samples the team take and how often.
Blood samples
You give blood samples before starting treatment, during treatment and after treatment. Where possible the team take these samples when you have blood taken as part of your routine care.
Researchers will use these samples to:
- find out what happens to these drugs in the body and how they affect the body
- look for substances in the blood (
biomarkers ) that could tell doctors how well the treatment is working - look for small pieces of the cancer
DNA in the blood (ctDNA )
The team will ask for a blood sample to compare the genes in your normal DNA with the in the DNA of your cancer. By doing so they hope to understand how genes affect cancer. You don’t have to agree to have this done.
Your body might make antibodies because you are having these drugs. This is called an . The team will use the blood samples to see if your body is having an immune response.
Poo samples
For the poo samples the team give you a kit to take home to collect the sample. They will tell you when and how to take the samples. The kit will also have instructions on how to take the sample.
Researchers will use these samples to look at the bacteria and viruses that occur naturally in your gut (the ). This is to find out more about the microbiome and how it might affect how well treatments work.
Quality of life
You fill in questionnaires:
- before starting treatment
- regularly during treatment
- after finishing treatment
The questions ask about:
- your general health
- side effects and symptoms
- what you can do in your daily life
These are quality of life questionnaires
Hospital visits
You see the doctor for tests before taking part. These tests include:
- a
physical examination - blood tests
- urine test
- heart scan (ECHO or
MUGA ) - heart trace (ECG)
- scans such as a CT scan, an MRI scan, a PET-CT scan or a bone scan. Your doctor will tell you which scan or scans you will have.
You see the doctor during treatment for blood tests and to see how you are.
After finishing treatment you see the doctor at:
- 1 month
- 2 months
- 3 months
Your doctor will then tell you how often they want to see you.
You have regular scans to see if your cancer has started to grow again. Your doctor will tell you how often you have the scans.
If a scan shows that your cancer is getting worse you stop treatment. The team will ask for a sample of tissue (biopsy). This is to look for biomarkers. You do not have to agree to have the biopsy done.
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.
| Dostarlimab, belrestotug and GSK6097608 can affect the . This may cause and other reactions in different parts of the body. For many people the inflammation and reactions are not too bad. For some people they can cause serious side effects. 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. 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 dostarlimab are:
- a drop in the red blood cells causing breathlessness and tiredness
- too little thyroid hormone being made by the
thyroid gland causing weight gain, tiredness and lack of energy - feeling or being sick
- diarrhoea
- itchy skin, a rash or both
- high temperature (fever)
- changes to how well your liver works
Belrestotug is a new drug and there might be side effects we don’t know about yet. The side effects reported so far include:
- skin changes such as itching, a rash and colour change
- tiredness (fatigue)
- high temperature (fever)
- allergic or sensitivity reaction during or just after having belrestotug that can cause a rash, shortness of breath, redness or swelling of the face and dizziness
- loss of appetite
GSK6097608 is a new drug and there might be side effects we don’t know about yet. The side effects reported so far include:
- tiredness (fatigue)
- chills
Your doctor will talk to you about the possible side effects of the treatments and answer any questions you might have before you agree to take part.
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
Andreas Polychronis
Supported by
GlaxoSmithKline (GSK)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
