"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
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.
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
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
- Have taken
steroidsor 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 drugsor 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
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.
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
If your cancer gets worse, the trial team may ask you to have another
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
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
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
- Tiredness (fatigue)
- Skin reactions such as rash, itching, hives, redness and dry skin
- Tummy (abdominal) pain
- Feeling sick
- Loss of appetite
- A drop in the number of red blood cells causing tiredness and breathlessness
- High temperature (fever)
- Stiff or painful joints
The most common side effects of the chemotherapy drugs in this trial include
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Feeling or being sick
- Changes to the way your kidneys work
- Change to the levels of certain substances and proteins in your blood
- Blood or protein in your urine
- High temperature
- Shortness of breath
- Tiredness (fatigue)
- Loss of appetite
- Numbness and tingling in your hands and feet (peripheral neuropathy)
- Muscle and joint pain
- Sore mouth
- Hair loss
We have more information about
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.
Dr Clive Mulatero