A trial of nivolumab for advanced non small cell lung cancer (CA209026)

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 drug called nivolumab as the first treatment for non small cell lung cancer that has spread to another part of the body.

If non small cell lung cancer has spread to another part of the body, doctors often treat it with chemotherapy. But researchers are looking for new treatments to help people in this situation. In this trial, they are looking at a drug called nivolumab.

Nivolumab works by blocking a body substance called PD-1. Blocking PD-1 helps the body’s immune system to attack cancer cells.

Some cancers produce large amounts of a protein called PD-L1. This is described as PD-L1 positive cancer. Researchers think that these cancers are more likely to respond to nivolumab. So, only people with PD-L1 positive cancer can take part in this trial.

In earlier clinical trials, nivolumab has helped people who’d already had other treatment for non small cell lung cancer. The aim of this trial is to see if nivolumab can help people who haven’t had any other treatment yet.

The researchers are comparing nivolumab with chemotherapy as the first treatment for non small cell lung cancer that has spread to another part of the body.

Who can enter

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

  • Have non small cell lung cancer that has come back or spread to another part of your body
  • Haven’t had any other treatment that reaches your whole body (systemic treatment) for cancer that has spread. You may take part if you had chemotherapy before or after surgery to remove your cancer, or radiotherapy after surgery as long as you finished this treatment at least 6 months ago. And if you’ve had radiotherapy for symptoms, this must have finished at least 2 weeks ago
  • Have cancer that can be measured on a scan
  • Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • Have satisfactory blood test results
  • Are at least 18 years old
  • Are willing to use reliable contraception during the trial and for up to 7 months afterwards if there is any chance you or your partner could become pregnant

To join this trial, you must have cancer that produces large amounts of a protein called PD-L1 (PD-L1 positive cancer). The trial team will send a sample of your cancer to a laboratory to test for this. They may be able to get a sample of tissue removed when you had surgery or a biopsy in the past. But if there isn’t a sample available, you will need to have a new biopsy.

You cannot join this trial if any of these apply. You

  • Have cancer that has changes to genes affecting proteins called EGFR or ALK and for which there may be another treatment available
  • Have cancer that has spread to your brain or spinal cord (the central nervous system) unless this has been successfully treated and you no longer take steroids, or only need to take a low dose
  • Have cancer that has spread to the tissues surrounding your brain (carcinomatous meningitis)
  • Have had major surgery or a serious injury in the last 2 weeks
  • Have had another type of cancer in the last 2 years unless it was a very early stage and has been successfully treated (the trial team can advise you about this)
  • Have an autoimmune disease
  • Have taken steroids or other drugs that damp down your immune system in the last 2 weeks (steroid creams and inhalers are allowed)
  • Have a condition affecting the lungs called interstitial lung disease if it is causing symptoms or the trial team think this could affect you taking part
  • Are known to be HIV, hepatitis B or hepatitis C positive
  • Have nerve damage from other treatment (peripheral neuropathy) unless it is only mild
  • Are known to be allergic or very sensitive to platinum drugs or other drugs used in the trial
  • Have any other medical condition or mental health problem that the trial team think could affect your taking part
  • Are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. The researchers need about 500 people with PD-L1 positive non small cell lung cancer to take part.

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.  Half the people in the trial have nivolumab. The other half have chemotherapy.

11749 Trial Diagram

If you are in the group having nivolumab, you have it through a drip into a vein once every 2 weeks. It takes about an hour each time. Each 2 week period is called a cycle of treatment. As long as you don’t have bad side effects, you can carry on having treatment for as long as it helps you.

If you are in the group having chemotherapy, you have 2 chemotherapy drugs through a drip into a vein. You have treatment in 3 week cycles of treatment. You can have up to 6 cycles.

Your doctor will decide which 2 chemotherapy drugs you have depending on the type of cancer you have.

If you have a type of non small cell lung cancer called squamous cell cancer, you have one of the following

If you have other types of non small cell lung cancer (non squamous), you have one of the following

  • Pemetrexed with cisplatin
  • Pemetrexed with carboplatin

After the first 6 cycles of treatment, people with non squamous cancer may continue to have pemetrexed on its own. This is called maintenance treatment. To help control the side effects of pemetrexed you will also have 2 vitamins called folic acid and vitamin B12.

If your cancer gets worse, the trial team may ask you to have another biopsy. They will use this sample to look for changes in certain proteins that may be in your cancer cells. If you don’t want to have this extra biopsy, you don’t have to. You can still take part in the trial.

If you are in the group having chemotherapy, you may be able to start having nivolumab if your cancer gets worse during the trial. Your doctor will talk to you about the possible risks and benefits of switching from chemotherapy to nivolumab. And they will ask you to sign another consent form.

Hospital visits

You see the trial team and have some tests before you start treatment. The tests include

You see the trial team and have regular blood tests throughout the trial. You have a CT or MRI scan every 6 weeks for nearly a year and then every 3 months after that.

When you finish treatment, you see the trial team about a month later and again 2 months after that. From then on, the trial team will check how you are about every 3 months. This may be at a hospital appointment or they may contact you by phone. They may want you to have more CT or MRI scans

Side effects

As nivolumab is a new drug, there may be side effects we don’t know about. In trials so far, the most common side effects have been

The most common side effects of the chemotherapy drugs in this trial include

We have more 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 Clive Mulatero

Supported by

Bristol-Myers Squibb

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 11749

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

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

Last reviewed:

Rate this page:

Currently rated: 4 out of 5 based on 10 votes
Thank you!
We've recently made some changes to the site, tell us what you think

Share this page