
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
This trial is comparing the combination of Dato-DXd, durvalumab and carboplatin with the combination of pembrolizumab and chemotherapy.
It is open to people with advanced non small cell lung cancer (NSCLC) who have not had treatment for their .
Doctors can treat advanced NSCLC that has spread with:
They can also teat advanced NSCLC with durvalumab after having had .
Paclitaxel, carboplatin, pemetrexed and cisplatin are drugs. They kill cancer cells by stopping them from dividing and growing.
Pembrolizumab is an immunotherapy drug. It works by helping the immune system to find, recognise and kill cancer cells.
Durvalumab is another type of immunotherapy drug. It also works by helping the immune system to find, recognise and kill cancer cells.
Datopotamab deruxtecan (Dato-DXd) is a type of drug called an antibody drug conjugate. It has two parts, they are:
Datopotamab finds a protein called TROP2 on the cancer cell. It attaches itself to the protein. It then releases the deruxtecan into the cancer cell damaging or killing the cell. This stops the cancer from growing.
Researchers think that the combination of Dato-DXd, durvalumab and carboplatin could be better than the pembrolizumab and chemotherapy.
The aims of this trial are to find out:
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.
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 any of these apply. You:
This is an international phase 3 trial. The team need about 1,000 people to take part worldwide with 50 people from the UK.
It is a randomised trial. A computer puts you into 1 of 2 treatment groups. Neither you nor your doctor chooses which group you are in. The 2 groups are:
Dato-DXd, durvalumab and carboplatin
You have Dato-DXd, durvalumab and carboplatin as a drip into a vein. You have all 3 drugs on the same day once every 3 weeks. Each 3 week period is a .
You have all 3 drugs for 4 cycles of treatment. You then continue to have Dato-DXd and durvalumab as above. This is as long as it is helping and the side effects aren’t too bad.
Dato-DXd can cause side effects to your mouth. To prevent this your doctor will give you instructions and a kit for you to look after your mouth. You must follow the instructions and use the kit before starting and during treatment.
Pembrolizumab and chemotherapy
You have pembrolizumab and chemotherapy as a drip into a vein.
Which chemotherapy you have depends on whether you have non squamous NSCLC or squamous NSCLC.
For non squamous NSCLC you have pemetrexed and carboplatin or cisplatin.
For squamous NSCLC you have paclitaxel and carboplatin.
You have pembrolizumab and chemotherapy once a week every 3 weeks for 4 cycles of treatment.
After this you can continue to have pembrolizumab for up to 35 cycles (about 2 years) as long as it is helping and the side effects aren’t too bad.
People with non squamous NSCLC who have pemetrexed can continue to have it for up to 35 cycles (about 2 years) as long as it is helping and the side effects aren’t too bad.
Samples for research
You give blood samples and tissue samples () as part of the trial. Wherever possible the team take these samples when you have bloods and tissue samples taken as part of your routine care.
Researchers will use these samples to:
You must agree to have some of these samples taken. Some you don’t have to agree to. Your doctor will tell you which these are. They will also tell you how often they take the samples.
Quality of life
You fill in questionnaires before starting treatment then:
The questions ask about:
These are quality of life questionnaires.
Symptoms diary
You have a diary to record any side effects of the mouth and throat you might have. A member of the team will go through the diary and explain it to you.
You see the doctor to have tests before taking part. These include:
You see the doctor regularly during treatment. This is to:
You have scans during your treatment and after treatment. Your doctor will tell you about the scans and when you have them.
You see the doctor when you finish treatment then:
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 and 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. |
The most common side effects of Dato-DXd are:
The most common side effects durvalumab are:
We have information about the side effects of:
Your doctor will tell you about the possible side effects of the treatments and answer any of your questions before you agree to take part.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Alastair Greystoke
AstraZeneca
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”