A trial of nivolumab, ipilimumab and chemotherapy for advanced lung cancer (CA209227)

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 (NSCLC) that has spread to another part of the body.

More about this trial

Chemotherapy is the usual treatment for advanced NSCLC. But for some people this might not work well. This is because of certain proteins on the cancer cells. These proteins can stop the body’s immune system attacking cancer cells. 

One protein is PD-L1. Nivolumab is a targeted cancer drug (a biological therapy). It works by blocking PD-L1. We know from research that nivolumab can help people with NSCLC.
 
There are 2 parts to this trial. In part 1 researchers looked at nivolumab, ipilimumab and chemotherapy. This part is now closed.

In part 2 the team are looking at nivolumab and chemotherapy.

The main aims are to find:

  • how well nivolumab works for NSCLC
  • how well nivolumab in combination with chemotherapy works for NSCLC
  • how safe these treatments are for people with NSCLC
  • how acceptable people find these treatments

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. 

You may be able to join this trial if all of the following apply. You

  • Have a non small cell lung cancer that has either come back after previous treatment (recurrent) or that is stage 4
  • Have an area of cancer that can be measured on a CT scan Open a glossary item or an MRI scan Open a glossary item
  • Have satisfactory blood test results
  • Have a sample of your cancer (a biopsy) available or be willing to have another biopsy
  • Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • Are willing to use reliable contraception during treatment and, depending on what treatment you have and whether you are male or female, up to 7 months afterwards (your doctor or nurse will give you more information about this)
  • Are at least 18 years old

You cannot join this trial if any of these apply

Cancer related

  • Your cancer has changes (mutations) to EGFR Open a glossary item and your cancer might respond to the treatments available for this
  • Your cancer has changes in the ALK protein and your cancer might respond to the treatments available for this
  • You have already had systemic treatment Open a glossary item, such as chemotherapy, since your cancer spread. You might be able to join if you had chemotherapy before or after surgery to remove your cancer or you had chemoradiation Open a glossary item for locally advanced cancer as long as any treatment was finished more than 6 months ago
  • You have cancer spread to your brain or spine. Unless it has been treated, you have no symptoms for at least 2 weeks before being randomised in this trial and you aren’t taking steroids or you are on a stable dose or reducing dose of 10 mg or less a day for at least 2 weeks before being randomised
  • You have inflammation of the lining of your brain (carcinomatous meningitis) caused by your cancer 
  • You have had radiotherapy to your cancer spread, apart from the brain and spine, to control symptoms in the past 2 weeks
  • You have another type of cancer that needs treatment
  • You have had another cancer apart from non melanoma skin cancers Open a glossary item and some early cancers Open a glossary item that were successfully treated at least 2 years ago and there hasn’t been any sign of since

Medical conditions

  • You must have recovered from the effects of any major surgery or injury at least 2 weeks before being put into a treatment group (randomised)
  • You have an active or are known to have an autoimmune disease Open a glossary item. You may be able to join if you don’t need any systemic treatment or your condition isn’t expected to come back
  • You are taking more than 10mg of steroids a day or any other medication that affects the immune system Open a glossary item within 2 weeks of randomisation apart from inhalers, creams and steroids as replacement for adrenal glands that aren’t working
  • You have a disease of the tissue around the air sacs of your lung that is causing symptoms or it may affect how the doctors look after you in this trial
  • You have HIV, hepatitis B or hepatitis C
  • You have moderate to severe nerve damage (peripheral neuropathy Open a glossary item)
  • You have a hearing problem
  • You have any other medical or mental health condition that the trial team think can affect you taking part 

Other 

  • You had a live vaccine Open a glossary item in the past 4 weeks or might need a live vaccine during treatment or in the 4 weeks after treatment
  • You are allergic or sensitive to any of the drugs or their ingredients used in the trial
  • You are pregnant or breastfeeding

Trial design

There are 2 parts to this trial. The 1st part is completed and now closed. Part 2 is now open. 

This is an international phase 3 trial. The researchers need 20 people from the UK to join part 2.

It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.  
 
The researchers will test a sample of your cancer tissue for the PD-L1 protein to find out how much is in your cancer. They'll do this before you are randomised into 1 of 2 treatment groups.

Half the people have nivolumab.

The other half have nivolumab and chemotherapy.

CA209227 trial diagram

You have nivolumab as an injection into a vein. You have it every 3 weeks. You continue treatment for 2 years as long as it is helping you and the side effects aren’t too bad. 

Your doctor will talk to you about what chemotherapy you’ll have as this depends on your type of lung cancer.

 If you have a squamous cell lung cancer Open a glossary item you have:

  • paclitaxel and carboplatin

If you have a non squamous cell lung cancer you have one of the following:

  • pemetrexed and cisplatin
  • pemetrexed and carboplatin

You have all of these as an injection into a vein every 3 weeks. Each 3 week period is called a cycle of treatment. You have 4 cycles of treatment. 

If you have non squamous cell lung cancer and are randomised to have nivolumab and chemotherapy you might continue to have pemetrexed with nivolumab after 4 cycles. Your doctor will talk to you about this. 

Tissue samples
The researchers will ask for a sample of your cancer that was removed when you had surgery or a biopsy Open a glossary item. You need to agree to have a biopsy done if a sample of your cancer isn’t available. 

They will also ask for another biopsy either before starting, or during, treatment. You don’t have to agree to this one. You can still take part in the trial.

These samples will be used to improve treatment in the future for people with NSCLC.  

The team will also take extra blood samples when you have your routine blood tests. They will use these to find more about what happens to these drugs in your body and how your body reacts to them. 

Quality of life
The trial team will ask you to fill in a questionnaire

  • before you start treatment
  • before the start of each treatment for 6 months
  • every 6 weeks during the rest of treatment
  • every 3 months for a year
  • then every 6 months

The questions will ask about how you feel and any symptoms or side effects you might have. This a quality of life study.

Hospital visits

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

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

During treatment you see the doctor regularly for a physical examination and blood tests. 

You have a CT scan or MRI scan every:

  • 6 weeks for the first year
  • 3 months till your cancer starts to grow again

After treatment you see the doctor you every 3 months. Or a member of the trial team will phone you to see how you are.

Side effects

The common side effects of nivolumab include:

  • tiredness
  • skin reactions such as a rash, redness, itching and dry skin
  • diarrhoea or constipation
  • feeling or being sick
  • tummy (abdominal) pain
  • loss of appetite
  • high temperature (fever)
  • joint pain
  • abnormal blood test results
  • chills
  • cough
  • dry mouth
  • inflammation of the mouth
  • headache
  • inflammation of the large bowel (colon)
  • inflammation of the lungs
  • loss of colour (pigmentation) from areas of the skin
  • muscle and bone pain
  • shortness of breath
  • swelling including face, arms and legs
  • change to the way yourr thyroid Open a glossary item works
  • tingling, burning, numbness or weakness of the arms, legs, hands and feet

We have more information on nivolumab

We have information on the side effects of:

Your doctor will talk to you about the side effects of all the drugs used in this trial before you agree to take part.

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 James Spicer

Supported by

Bristol-Myers Squibb
Experimental Cancer Medicine Centre (ECMC)
Ono Pharmaceutical Co. Ltd

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14094

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.”

Last reviewed:

Rate this page:

No votes yet
Thank you!
We've recently made some changes to the site, tell us what you think