A trial looking at durvalumab and tremelimumab for non small cell lung cancer (POSEIDON)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Lung cancer
Non small cell lung cancer

Status:

Closed

Phase:

Phase 3

This trial is for people with non small cell lung cancer that has spread from where it started in the lung (advanced). It is for people who are going to have treatment for the first time. 

More about this trial

Advanced non small cell lung cancer (NSCLC) means that the cancer has spread to another part of the body (metastatic) or into the surrounding tissues (locally advanced). It is also called stage 4 lung cancer.

Chemotherapy is the usual treatment (standard treatment Open a glossary item) for advanced NSCLC. You usually have a platinum drug Open a glossary item such as carboplatin or cisplatin. But doctors are looking for new ways to help people with advanced NSCLC. 

Durvalumab (MEDI4736) and tremelimumab are 2 types of targeted cancer drugs called monoclonal antibodies. They seek out cancer cells by looking for a particular protein and attaching to it. Durvalumab and tremelimumab seek out 2 different proteins. 

Researchers think that durvalumab and tremelimumab may help your immune system attack the cancer and stop it from growing.

Everyone taking part in this trial has 1 of the following: 

  • durvalumab, tremelimumab and standard treatment
  • durvalumab and standard treatment
  • standard treatment

The main aims of this trial are to: 

  • find out how well durvalumab and tremelimumab work as a treatment
  • learn more about the side effects
  • find out what happens to durvalumab and tremelimumab in your body
  • look at gene changes (mutations) in the cancer
  • learn more about people’s quality of life Open a glossary item

Who can enter

The following bullet points list 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 stage 4 NSCLC and you can’t have treatment, such as surgery or radiotherapy, to try to cure your cancer
  • don’t have a change (mutation) in receptors called epidermal growth factor receptors (EGFR) or a type of the ALK gene Open a glossary item called ALK fusion
  • are going to have treatment for NSCLC that reaches your whole body (systemic) for the 1st time. You might be able to take part if you had a platinum drug that was part of a treatment to try to cure your cancer more than a year ago   
  • have a suitable sample of cancer available that is less than 3 months old (or be willing to have a sample taken) that the team can test for a biomarker Open a glossary item called PD-L1
  • have at least 1 area of cancer that can be seen and measured on a scan 
  • you have satisfactory blood tests results and you haven't had a blood transfusion Open a glossary item in the past 4 weeks
  • are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1) 
  • are at least 18 years old  
  • are willing to use reliable contraception during treatment and for 3 months after the final dose of durvalumab, or 6 months after the final dose of durvalumab and tremelimumab, if there is any possibility you or your partner could become pregnant

Who can’t take part
You cannot join this trial if any of these apply.

Cancer related
You:

  • have a type of NSCLC called sarcomatoid or mixed small-cell lung cancer
  • have NSCLC that has spread to the tissues surrounding the spinal cord Open a glossary item 
  • have NSCLC that has spread to your brain or the tissues surrounding your brain, unless it’s stable and you haven’t taken steroids in the past 2 weeks
  • have had durvalumab, tremelimumab or any other similar drugs 
  • are having treatment for your cancer with chemotherapy, a targeted cancer drug (biological therapy), an experimental treatment or hormone therapy
  • have had a major surgery in the last 28 days (you may be able to take part if it was a small operation to remove some of the cancer and help with symptoms)
  • have had radiotherapy in the past, unless you have finished it more than a year ago, or it was given to help with symptoms (palliative radiotherapy)
  • have had a donor transplant (allogeneic transplant Open a glossary item)
  • have had another cancer in the last 5 years apart from cancers that haven’t spread (carcinoma in situ Open a glossary item) or basal or squamous cell skin cancer that have been successfully treated

Medical conditions
You:

  • weigh less than 30 kg (4 stone 10lb)
  • are taking part in another clinical trial or you have had an experimental treatment in the past year
  • can’t have treatment with a platinum drug for any reason
  • have taken drugs that damp down your immune system (immunosuppressants) such as steroids in the past 2 weeks, unless it was a very small dose, an inhaler or a cream  
  • have HIV
  • have hepatitis B or hepatitis C
  • have had or have active tuberculosis 
  • have an infection that needs treatment
  • have heart problems such as congestive heart failure, high blood pressure that isn’t controlled by medication or angina that is not controlled 
  • have problems with your digestive system Open a glossary item such as colitis or Crohn’s disease 
  • have an autoimmune disease Open a glossary item
  • have had a live vaccine Open a glossary item in the past 30 days 
  • have any other serious medical condition or mental health problem that the trial team thinks could affect you taking part 

Other
You:

  • are pregnant or breastfeeding
  • are sensitive to tremelimumab, durvalumab or anything they contain

Trial design

This is an international phase 3 trial. The researchers hope that around 1000 people worldwide will take part. 

This trial is randomised. The people taking part are put into 1 of the following treatment groups by computer:

  • durvalumab, tremelimumab and standard treatment
  • durvalumab and standard treatment
  • standard treatment

Neither you nor your doctor will be able to decide which group you are.

study diagram

Durvalumab 
You have durvalumab as a drip into a vein every 3 weeks, for 12 weeks (around 3 months). Then you have it every 4 weeks. It takes about an hour each time you have it. 

You continue to have durvalumab for as long as your doctor feels it is helping you.  

Tremelimumab 
You have tremelimumab as a drip into a vein. You have it every 3 weeks, for 9 weeks. After this, you have no treatment with tremelimumab for 7 weeks. You then have a final dose of tremelimumab. 

It takes about an hour each time you have it. 

Standard treatment
You have 1 of the following treatments:

Your doctor will explain which treatment is best for you.

Quality of life
Everyone taking part in this trial completes a quality of life questionnaire before starting treatment and at set times during the trial.

The questionnaires ask about how you have been feeling and what side effects you have had. 

Blood tests 
You have extra blood tests as part of this trial. Researchers want to:

  • find out what happens to durvalumab and tremelimumab in your body
  • look for substances called biomarkers Open a glossary item to see why treatments work better for some people than others

The research team might also ask to keep your blood samples and use them in future research studies. You don’t have to agree to this if you don’t want to. You can still take part in this trial. 

Tissue sample
The researchers will ask to use a sample of your cancer that was taken less than 3 months ago. You need to have a biopsy Open a glossary item if there isn’t a suitable sample available.  Doctors want to:

  • check whether there is a marker on your cancer called PD-L1
  • look at the number of gene changes in the cancer (the tumour mutation burden)

Doctors will also ask you to have another biopsy if your cancer gets worse after treatment with durvalumab and tremelimumab. You don’t have to agree to this if you have treatment with:

  • durvalumab and standard treatment
  • standard treatment

Hospital visits

You see a doctor and have some tests before taking part. These tests include:

  • physical examination
  • heart trace (ECG Open a glossary item)
  • blood tests
  • urine test
  • CT scan or MRI scan

During treatment, you see your doctor for blood tests and a physical examination every 3 weeks, for 3 months. You then see them every 4 weeks. 

Your doctor will tell how often you see them if you have the standard treatment. 

You have a CT scan or MRI scan every 6 weeks while you are having treatment. After 3 months, you have a CT scan or MRI scan every 8 weeks. 

Your treatment continues for as long as your cancer gets better or stays the same, and the side effects aren’t too bad. You stop treatment if your cancer gets worse, unless your doctor feels it is still helping you. 

You may be able to continue to have treatment after the trial finishes if your doctor feels that the treatment is still helping you.

When you finish treatment, you see the trial team: 

  • every month for 4 months
  • then every 2 months

The trial team can also call you every 2 months to see how you are. 

Side effects

The trial team monitor you while you are having treatment. They will give you a phone number to call them if you are worried about anything. 

The team will tell you about the possible side effects before the start of treatment. 

The common side effects of durvalumab and tremelimumab are:

We have information about the side effects of:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Siow-Ming Lee

Supported by

AstraZeneca

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15097

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

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