A trial looking at denosumab with chemotherapy for non small cell lung cancer
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at a drug called denosumab with chemotherapy for non small cell lung cancer. It is for people with non small cell lung cancer (NSCLC) that has spread to another part of their body.
Doctors can treat NSCLC with chemotherapy. They usually use a 
, such as cisplatin or carboplatin alongside another chemotherapy drug. In this trial, they are looking at adding a drug called denosumab.
Denosumab is a type of biological therapy called a monoclonal antibody. Doctors use it to treat cancer that has spread to the bones or to delay it spreading to the bones.
The researchers want to find out more about how denosumab works in people with NSCLC. They also want to find out about how denosumab works alongside platinum chemotherapy drugs.
The researchers will look at certain substances () in your cancer tissue and blood.
The main aim of this trial is to find out if there is a link between the biomarkers and how well the combination of denosumab and platinum chemotherapy works for NSCLC.
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 to another part of your body (stage 4)
- Are going to have either pemetrexed or gemcitabine with either cisplatin or carboplatin
- Have an area of cancer that can be seen 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 willing to use reliable contraception during treatment and for 7 months afterwards if there is any chance you or your partner could become pregnant
- Are at least 18 years old
You cannot join this trial if any of these apply
- You have cancer with receptors for a protein called epidermal growth factor receptor (
EGFR positive cancer ) or cancer that has a change (mutation ) to a gene called EML4-ALK (your doctor can tell you this) - Your cancer has spread to your brain
- You have already had treatment for NSCLC that has spread. You can join if you had treatment when your cancer hadn’t spread to another part of your body, as long as you finished treatment at least 6 months ago
- You are going to have bevacizumab (Avastin)
- You have had radiotherapy in the past 2 weeks, or 4 weeks if you had radiotherapy to your chest
- You have already had denosumab
- You have had a drug called a
bisphosphonate in tablet form for more than a year - You have had more than 1 treatment of a bisphosphonate drug as an injection into a vein
- You have or have had serious problems with your teeth or mouth
- You may need to have dental work, such as a surgery or a tooth taken out during the trial
- You have had another cancer in the past 5 years apart from some
early cancers that have been successfully treated - You are HIV, hepatitis B or hepatitis C positive
- You are sensitive to any of the drugs used in this trial, or anything they contain
- You are taking medication as part of another clinical trial
- You are pregnant or breastfeeding
Trial design
This is an international phase 2 trial. The researchers need 216 people to join.
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. And neither of you will know which group you are in. This is called a double blind trial.
- 2 out of every 3 people have denosumab with chemotherapy
- 1 out of every 3 people have a dummy drug (placebo) with chemotherapy
You have denosumab (or the dummy drug) as injections under your skin. You have the chemotherapy drugs as injections into a vein. You have treatment every 3 or 4 weeks, between 4 and 6 times.
When you finish chemotherapy, you can continue to have denosumab (or dummy drug) alone as long as your doctor thinks it is helping you and the side effects aren’t too bad. You have it every 3 or 4 weeks.
The researchers will ask for a sample of your cancer that was removed when you had surgery or a . They will also take some extra blood samples. They will use these to find out what happens to denosumab in the body. They may also use these samples in future research.
Hospital visits
You see the doctor and have some tests before you take part in this trial. The tests include
- A physical examination
- Blood tests
- Urine test
- Examination of your mouth
- Bone scan
- CT scan or MRI scan
During treatment you see the doctor every 3 to 4 weeks depending on how often you have treatment. You have a bone scan and CT scan or MRI scan every 6 weeks for 11 months and then about every 3 months until your cancer starts to grow again.
If your cancer starts to grow during treatment you see the doctor every 3 to 4 weeks for treatment but you will have no further scans.
When you finish treatment you see the doctor every 3 months.
Side effects
The most common side effects of denosumab are
- Low levels of phosphorous and calcium in the blood
- Shortness of breath
We have more information on denosumab. We also have information on the side effects of chemotherapy for lung cancer.
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.
Chief Investigator
Dr Conrad Lewanski
Supported by
Amgen
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
