A trial looking at denosumab and chemotherapy for non small cell lung cancer that has spread to another part of the body (SPLENDOUR)
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This trial looked at a drug called denosumab and chemotherapy for non small cell cancer that had spread to another part of the body.
It was for people having their first treatment for non small cell lung cancer that had spread. Cancer that has spread is called advanced cancer.
This trial was open for people to join between 2015 and 2018. The team published the results in 2020.
More about this trial
Doctors usually treat non small lung cancer (NSCLC) that has spread with chemotherapy. This can help but doctors are always looking for ways to improve treatment.
In this trial, they looked at adding a drug called denosumab to chemotherapy. Denosumab is a type of targeted drug called a monoclonal antibody. It helps to prevent fractures and other cancer related bone problems in adults with cancer that has spread to the bones.
Researchers thought that having denosumab alongside chemotherapy might improve treatment for this group of people. Results from earlier trials suggested that it might work. But the researchers weren’t sure so wanted to find out more.
The aims of the trial were to:
- find out if adding denosumab to chemotherapy improves treatment
- learn more about the side effects
Summary of results
The trial team found that adding denosumab to chemotherapy didn’t improve treatment. This trial closed earlier than planned as it was difficult to get enough people to take part.
About this trial
This was a phase 3 trial. 514 people took part. There were 2 treatment groups. Everyone was put into a treatment group at random:
- 252 people had standard chemotherapy (this was the
control group) 
- 257 people had standard chemotherapy and denosumab
Neither they nor their doctor could choose which group they were in.
The team say just over half (50%) of people already had cancer spread to the bones when they joined the trial.
People in the control group also had zoledronic acid if the cancer had spread to the bones.
Results
The trial team looked at how well treatment worked. To do this they looked at how long people lived. This is called overall survival.
They found on average this was:
- just under 9 months in the control group
- just over 8 months in people who had chemotherapy and denosumab
The difference between the 2 groups was not statistically significant. This means it could have happened by chance.
The team also found no difference in overall survival when they compared people who had cancer spread to the bone with those who didn’t.
Side effects
People who had denosumab and chemotherapy had more problems with:
- tiredness (fatigue)
- hypertension
The team say the side effects weren’t too bad and were easy to manage.
Conclusion
The research team concluded that adding denosumab to chemotherapy didn’t improve treatment for people with lung cancer that had spread.
Even when a trial shows a treatment isn’t useful for a particular cancer, it adds to our knowledge and understanding of cancer and how to treat it.
Where this information comes from
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists and published in a medical journal. The figures we quote above were provided by the research team. We have not analysed the data ourselves.
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 Sarah Danson
Supported by
European Organisation for Research and Treatment of Cancer (EORTC)
European Thoracic Oncology Platform (ETOP)
NIHR Clinical Research Network: Cancer
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
