A trial looking at MEDI4736 and tremelimumab or usual treatment for people with non small cell lung cancer that has spread (ARCTIC)

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 looking at a new drug called MEDI4736 and another drug called tremelimumab for people with non small cell lung cancer. It is for people whose cancer has grown into surrounding tissues or has spread to another part of the body. The trial is comparing MEDI4736 and tremelimumab with usual treatment for people with non small cell lung cancer.

More about this trial

If non small cell lung cancer has spread into lymph nodes Open a glossary item on the other side of your chest, surrounding tissues, or to another part of your body, it is called advanced non small cell lung cancer. Doctors can treat advanced non small lung cancer with treatments such as chemotherapy Open a glossary item, radiotherapy Open a glossary item or biological therapy Open a glossary item. These can help but researchers are always looking for new treatments.

MEDI4736 is a type of biological therapy called a monoclonal antibody. It seeks out cancer cells by looking for a particular protein and attaching to it. The researchers think that by doing this, MEDI4736 may help your immune system Open a glossary item to attack your cancer and stop it from growing.

Tremelimumab is also a type of monoclonal antibody. It also works by triggering the body’s immune system to attack cancer cells.

In this trial, people have one of the following

  • MEDI4736
  • Tremelimumab
  • MEDI4736 and tremelimumab
  • Usual treatment doctors use to treat this type of cancer

The type of treatment you have depends if you have a gene Open a glossary item change (mutation Open a glossary item) in your lung cancer cells. The doctors will test for this before you start treatment.

The main aims of this trial are to

  • Find out how well MEDI4736 and tremelimumab work together or on their own to treat non small cell lung cancer compared with usual treatment
  • Find out what happens to MEDI4736 in your body
  • Learn more about the side affects

Who can enter

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 surrounding tissue or lymph nodes (stage 3B) or has spread to another part of your body (stage 4) OR your cancer has come back or got worse after treatment for cancer that had spread into surrounding tissues
  • You have had a platinum Open a glossary item chemotherapy drug and at least 1 other treatment that reached your whole body (systemic treatment Open a glossary item)
  • Your cancer is either PD-L1 positive or PD-L1 negative (the trial team will test a sample of your cancer tissue for this)
  • You have at least one area of cancer that hasn’t been treated with radiotherapy, can be seen on a scan and measures at least 10mm across
  • You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • You have satisfactory blood test results
  • You are at least 18 years old
  • You are willing to use reliable contraception during treatment and for 3 months after the final dose of MEDI4736 or for 6 months after the final dose of MEDI4736 and tremelimumab. If you have usual treatment, the trial team can tell you more about how long you should use reliable contraception for.

You cannot join this trial if any of these apply.

  • You have cancer that has spread to your brain, the tissues surrounding your brain or is pressing on your spinal cord (spinal cord compression Open a glossary item), unless you have had treatment, you don’t have symptoms and you haven’t taken steroids or drugs to prevent fits (anticonvulsants) for at least a month
  • Your tissue sample (biopsy Open a glossary item) shows that you have small cell lung cancers cells combined with non small cell lung cancer cells
  • You have a certain type of EGFR TK gene change (an activating mutation)
  • You have had treatment in the last 3 weeks (2 weeks if you had drugs called erlotinib, gefitinib or crizotinib and 6 weeks if you had chemotherapy drugs called nitrosoureas Open a glossary item or mitomycin C)
  • You have already had a drug that targets PD-1 or PD-L1 (the trial team can tell your more about this)
  • You have had radiotherapy in the last 4 weeks unless you had it for symptoms and it wasn’t to the lung
  • You are having any other anti cancer treatment
  • You have problems with your immune system Open a glossary item or take drugs such as steroids that damp it down (there are some exceptions to this that the trial team can explain)
  • You have had a severe autoimmune disease Open a glossary item in the past 2 years
  • You have problems with your digestive system Open a glossary item such as Crohn’s disease or ulcerative colitis
  • You have had major surgery in the last 4 weeks
  • You have (or had) tuberculosis
  • You have hepatitis B or C
  • You are known to be HIV positive
  • You have high blood pressure that isn’t controlled with medication
  • You have certain heart problems (the trial team can advise you about this)
  • You have had an organ transplant
  • You have had experimental treatment as part of a clinical trial in the last month
  • You still have any moderate to severe side effects from earlier treatment (unless the study drug is unlikely to make them worse) or mild side effects from immunotherapy Open a glossary item
  • You are known to be sensitive to MEDI4736 or anything it contains (the trial team can advise you about this)
  • You have had a live vaccination Open a glossary item in the past month
  • You have had another cancer in the last 5 years apart from successfully treated early cancers Open a glossary item or any other cancer that has been treated with the aim to cure and there hasn’t been any sign of it for at least 5 years
  • You have any other medical condition or mental health condition that could affect your taking part (the trial doctors can advise you about this)
  • You are pregnant or breast feeding

As well as the above, if you are joining part B of the study, none of the following can apply.

  • You have had monoclonal antibody treatment that targets CTLA-4 on immune cells (the trial team can tell you more about this)
  • You have a long term inflammatory condition or type of autoimmune disease such as Grave’s disease or rheumatoid arthritis unless you have been free from symptoms in the last 3 years
  • You have a condition called diverticulitis
  • You have a condition called sarcoidosis syndrome
  • You are known to be sensitive to tremelimumab or anything it contains

Trial design

The trial team need 1,560 people to take part. This is a phase 3 trial. It is randomised. The people taking part are put into treatment groups by computer. Neither you nor your doctor will be able to decide which group you are in.

This trial has 2 parts. You join either part A or part B . The trial team will test a sample of your tumour for PD-L1 receptors. If a cancer has large amounts of PD-L1, it is described as being PD-L1 positive. If a cancer has small amounts of PD-L1 it is described as being PD-L1 negative. Depending on the results of this you will be put into part A or part B.

Please note. The trial team don't need any more people to join Part A. Part A is now closed. People are now being put into Part B if they are eligable to take part.

If your cancer is PD-L1 positive you join part A. You have one of the following treatments

  • MEDI4736
  • Usual treatment recommended by your doctor

If your cancer is PD-L1 negative you join part B. You have one of the following treatments

  • MED14736
  • MED14736 and tremelimumab
  • Tremelimumab
  • Usual treatment recommended by your doctor

If you have usual treatment recommended by your doctor, you have 3 treatment options. You and your doctor can decide which treatment is best for you. The 3 treatments are already used to treat non small cell lung cancer and include one of the following

Diagram for MED15736

If you have MEDI473, you have it as a drip into a vein every 2 weeks. This takes about an hour each time.

If you have tremelimumab, you have it as a drip into a vein. You have tremelimumab once a month for 6 months. And then every 3 months for 6 months. This takes about an hour each time.

If you are in the usual treatment group, you have gemcitabine or vinorelbine as a drip into a vein. The trial team can tell you more about how often you have these drugs. Erlotinib is a tablet you take every day.

For both parts of the trial, and for everybody taking part, as long as treatment is helping you and the side effects aren’t too bad, you have treatment for a year.

If you have MEDI476, tremelimumab or both, and you complete 12 months of treatment, you may have further treatment with these drugs if your cancer gets worse. The trial team can tell you more if this applies to you.

You have extra blood tests as part of this trial. Where possible you have these at the same time as your routine blood tests. The researchers want to find out what happens to MEDI4736 and tremelimumab in the body (pharmacokinetics Open a glossary item) and to look for substances called biomarkers Open a glossary item to find out why treatment might work for some people and not for others.

The researchers may also ask to take tissue samples (biopsies) Open a glossary item of your cancer at the beginning and during treatment. They will look for biomarkers and they may use it for other tests in the future. If you don’t want to give these samples for research, you don’t have to. You can still take part in the trial.

Everybody taking part will be asked to fill out a questionnaire before starting treatment, at set times during the trial and after finishing treatment. The questionnaire will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study Open a glossary item.

Hospital visits

You see the doctor to have some tests before taking part in this trial. These tests include

  • Physical examination
  • Heart trace (ECG Open a glossary item)
  • Urine test
  • Blood tests
  • CT scan or MRI scan

You have a CT or MRI scan every 2 months while you are having treatment. When you finish treatment you see the trial team within a month. They will repeat some of the tests you had when you joined the trial.

If you had MEDI4736, tremelimumab, or both and the treatment worked, you see the trial team every month for 4 months and then every 2 months after that. If you had these drugs and the cancer got worse during the trial, the doctors may recommend other treatment but you see the trial team for check up every month for 3 months.

If you have usual treatment, you see the trial team for a check up every 2 months after you finish treatment to see how you are getting on.

The trial team continue to follow everyone up every 2 months for about 1 year. This may be at the hospital or they may phone you at home. After a year, you go to hospital every 6 months for a check up.

When you finish treatment, everyone has a CT scan or MRI scan every 2 to 3 months. How often you have the scans depends on the hospital you were treated at and if your cancer got worse during treatment. The trial team can tell you more about this.

Side effects

One of the aims of this trial is to learn more about the side effects of treatment. You will be given a telephone number so you can contact the trial team if you are worried about anything.

 MEDI14736 is a new drug and so there may be side effects we don’t know about yet.  The most common side effect of MEDI4736 is tiredness (fatigue)

The most common side effects of tremelimumab are

The most common side effects of having MEDI14736 and tremelimumab together are

  • Tiredness
  • Diarrhoea
  • A high level of an enzyme Open a glossary item in your blood called amylase

There is a small chance that you may have an allergic reaction to MEDI4736 or tremelimumab. While having these drugs, you will be closely monitored. You may also have a reaction hours or days after having treatment. The trial team will tell you what to look for and what to do if this happens.

We have information about

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

Dr Tony Talbot

Supported by

AstraZeneca
Experimental Cancer Medicine Centre (ECMC)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13281

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

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