“I think it’s really important that people keep signing up to these type of trials to push research forward.”
A trial looking at denosumab and chemotherapy for non small cell lung cancer that has spread to another part of the body (SPLENDOUR)
Coronavirus and cancer
We know it’s a worrying time for people with cancer, we have information to help. If you have symptoms of cancer contact your doctor.
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 denosumab and chemotherapy for non small cell cancer that has spread to another part of the body.
More about this trial
In this trial, they are looking at a drug called denosumab alongside chemotherapy. Denosumab is a type of targeted cancer drug called a monoclonal antibody. Doctors use it to treat cancer that has spread to the bones or to delay it spreading to the bones.
Researchers think that having denosumab alongside chemotherapy that includes a
The aims of the trial are to
- Find out how well denosumab and chemotherapy work together to treat non small cell lung cancer compared with chemotherapy alone
- Learn more about the side effects
Who can enter
The following bullet points list the entry conditions for this trial. If you are unsure about any of these speak with your doctor or the trial team. They will be able to advise you.
You may be able to join this trial if all of the following apply.
- You have non small cell lung cancer that has spread to another part of the body
- Your cancer can be seen on a scan that was done within 28 days of joining the trial
- The trial team can have a look at a tissue sample taken when you had surgery or a
- You are well enough to be up and about for at least half the day (performance status 0,1 or 2)
- You have satisfactory blood test results
- You are at least 18 years old
- You are willing to use reliable contraception during treatment and for 6 months afterwards if there is any chance that you or your partner could become pregnant
You cannot join this trial if any of these apply. You
- Have cancer that has a certain type of
EGFR gene change(EGFR positive cancer) or a change ( mutation) to a gene called ALK
- Have cancer that has spread to your brain
- Have already had treatment for non small cell lung cancer that has spread to another part of the body. You may still be able to take part if you had chemotherapy or radiotherapy just before or after surgery or a combination of both, as long as you finished treatment at least 6 months ago. You also might be able to take part if you had radiotherapy without chemotherapy or have had 1 treatment with an
immunotherapy drugcalled a checkpoint inhibitors such as nivolumab
- Are currently having treatment with an immunotherapy drug called a checkpoint inhibitor such as nivolumab
- Have had denosumab in the past unless you only had 2 doses and it was more than 6 months ago to treat a bone condition called osteoporosis
- Have had a drug called a
bisphosphonatein tablet form for more than a year
- Have had more than 1 treatment of a bisphosphonate drug as an injection into a vein
- Have ever had an infection in the bone (osteomyelitis) or a rare condition called
osteonecrosisof the jaw
- May need dental work, such as a surgery or a tooth taken out during the trial or you have had dental surgery that hasn’t healed well
- Have certain heart problems
- Have high blood pressure that isn’t well controlled with medication
- Have diabetes that isn’t well controlled with medication
- Have an infection that isn’t getting better
- Have an active hepatitis B or hepatitis C infection
- Are known to be HIV positive
- Have had experimental treatment as part of a clinical trial in the last month
- Have had another cancer in the last 2 years apart from successfully treated
- Have any other serious medical condition or mental health problem that the trial team think could affect you taking part
- Are pregnant or breastfeeding
This is a phase 3 trial. It is randomised. The trial team need 1,000 people worldwide to take part. 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.
- One group have chemotherapy and denosumab
- The other group have chemotherapy
You have 1 of 4 chemotherapy combinations. They are usual treatment for non small cell lung cancer that has spread. The type you have depends on what your doctor think is best for you. They will discuss these options with you in more detail. You have one of the following
- Cisplatin and gemcitabine
- Carboplatin and gemcitabine
- Cisplatin and pemextred
- Carboplatin and pemextred
You have denosumab as injections under your skin. You have treatment every 3 or 4 weeks. You continue to have it even if your cancer gets worse, as long as the side effects aren't too bad.
You have the chemotherapy drugs as injections into a vein. Each 3 week period is called a cycle of treatment. You have between 4 and 6 cycles of treatment.
The researchers will ask for a sample of your cancer that was removed when you had surgery or a
The researchers will also take some extra blood samples to look for substances called
You see the doctor to have some tests before taking part in this trial. These tests include
- Physical examination
- Heart trace (
- Urine test
- Blood tests
- CT scan
You may also have a
You have treatment at the hospital. You see the trial doctor every 3 weeks for a check up.
When you finish treatment you see the trial doctor a month later for a check up and some blood tests. You see them about every 2 months after that.
You have a CT or
How to join a clinical trial
Dr Sarah Danson
NIHR Clinical Research Network: Cancer
Experimental Cancer Medicine Centre (ECMC)
European Organisation for Research and Treatment of Cancer (EORTC)
European Thoracic Oncology Platform (ETOP)