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:

Lung cancer

Non small cell lung cancer

Status:

Closed

Phase:

Phase 2

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 platinum drug Open a glossary item , 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 (biomarkers Open a glossary item ) 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

Trial diagram

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 biopsy Open a glossary item . 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.