A trial looking at denosumab and chemotherapy for non small cell lung cancer that has spread to another part of the body (SPLENDOUR)

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 denosumab and chemotherapy for non small cell cancer that has spread to another part of the body.

More about this trial

Doctors usually treat non small lung cancer that has spread with chemotherapy. This can help but doctors are always looking for ways to improve treatment.

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 platinum drug Open a glossary item may help people with non small cell lung cancer. But they want to find out more.

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 biopsy Open a glossary item.
  • 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 Open a glossary item (EGFR positive cancer) or a change (mutation Open a glossary item) 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 drug Open a glossary item called 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 bisphosphonate Open a glossary item in 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 osteonecrosis Open a glossary item of 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 early cancers Open a glossary item
  • Have any other serious medical condition or mental health problem that the trial team think could affect you taking part
  • Are pregnant or breastfeeding

Trial design

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

Diagram for SPLENDOUR

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 biopsy Open a glossary item. They might also ask to take a sample if your cancer gets worse.

The researchers will also take some extra blood samples to look for substances called biomarkers Open a glossary item to find out why treatment might work for some people and not for others. They might also ask if they can use any leftover samples for future research. But you don't have to agree to this if you don’t have to. You can still take part in the trial.

Hospital visits

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

  • Physical examination
  • Heart trace (ECG Open a glossary item)
  • Urine test
  • Blood tests
  • CT scan

You may also have a bone scan Open a glossary item.

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 PET-CT scan Open a glossary item before your 4th cycle of treatment and every 3 months until your cancer starts to grow again.

Side effects

The most common side effects of denosumab are

  • Low levels of phosphate and calcium in the blood
  • Shortness of breath
  • Muscle and joint pain 

We have more information on denosumab. We also have information on the side effects of

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 Sarah Danson

Supported by

NIHR Clinical Research Network: Cancer
Experimental Cancer Medicine Centre (ECMC)
European Organisation for Research and Treatment of Cancer (EORTC)
European Thoracic Oncology Platform (ETOP)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12601

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

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

Last reviewed:

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