A trial looking at atezolizumab and cabozantinib for non small cell lung cancer that has spread (CONTACT 01)

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

Secondary cancers

Status:

Closed

Phase:

Phase 3

This trial is comparing atezolizumab and cabozantinib with docetaxel for people with non small cell lung cancer.

It is for people whose cancer has spread elsewhere in the body. This is advanced lung cancer.

More about this trial

Doctors are looking for ways to improve treatment for people with advanced non small cell lung cancer (NSCLC).

In this trial they are looking at a new combination of drugs. This includes 2 drugs called atezolizumab and cabozantinib.

Atezolizumab is a drug you may have to treat advanced NSCLC that has got worse. It is an immunotherapy. It helps the immune system Open a glossary item to find and kill cancer cells.

Cabozantinib is a type of cancer growth blocker. It stops signals that cancer cells use to divide and grow. It is a new drug for lung cancer. Researchers want to find out if adding it to atezolizumab slows cancer growth.

Docetaxel is a chemotherapy drug. It is a usual treatment for NSCLC that has spread.

In this trial some people have atezolizumab and cabozantinib. And some people have docetaxel.

The main aims of the trial are to:

find out how safe it is to have atezolizumab and cabozantinib together
find how well this combination of treatment works compared to docetaxel
learn more about the side effects

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.

Who can take part

You may be able to join this trial if all of the following apply. You:

have NSCLC that has spread elsewhere in the body
have cancer that got worse during or after having an immunotherapy and chemotherapy that included a platinum drug . The team check which treatments you had and when you had them to see if you are suitable for the trial
have an area of cancer the doctor can see and measure on a scan
have a sample of tissue available for the trial team to do some tests on or you are willing to give a new sample
are well enough to carry out all your normal activities but you might not be able to do heavy physical work (performance status of 0 or 1)
have satisfactory blood test results
are willing to use reliable contraception during the trial and for a period of time afterwards if there is a chance you or your partner could become pregnant
are at least 18 years old

Who can’t take part

Cancer related
You cannot join this trial if any of these apply. You:

have cancer that has spread to the brain and spinal cord unless it isn’t causing symptoms, has been treated and is stable
have any other cancer or had another cancer in the last 3 years that needs treatment apart from non melanoma skin cancer , prostate cancer or carcinoma (CIS) of the prostate, cervix or breast that has been successfully treated
have lung cancer with the EGFR or ALK gene change
have had cabozantinib, docetaxel or another similar drug in the past
have had an experimental drug in the last 28 days
have pain caused by cancer that isn’t well controlled with medication
have side effects from past treatments that aren’t getting better apart from hair loss or moderate numbness and tingling in your hands and feet

Medical conditions
You can’t join the trial if the following apply. You:

have areas of fluid on the lung, heart or tummy that need frequent draining
have severe liver damage
have had a serious heart problem including a heart attack or a stroke within the last 6 months, you have an abnormal heart rhythm or another heart condition that needs treatment. The trial team check if you have a heart condition before you join the trial
have had major surgery in the last 4 weeks or need to have major surgery soon
have an autoimmune disease unless it is type 1 diabetes, hair loss (alopecia), thyroid problems that are controlled by medications or certain skin conditions that don’t need treatment
have scarring on the lungs or active inflammation of the lungs (pneumonitis )
have had a stem cell transplant or an organ transplant
have had treatment to stimulate the immune system such as interferon in the last 2 weeks or this treatment hasn’t completely cleared your body
have had treatment that damps down the immune system such as steroids within 2 weeks of starting trial treatments unless it was a low dose
are taking drugs such as warfarin to thin your blood
have had a blood clot in your leg or lung within 6 months of starting trial treatment
have high blood pressure that isn’t well controlled with medication
have problems with your digestive system such as areas of cancer, inflammatory bowel disease or a blocked bowel
have areas of cancer that have grown into the blood vessels in the lungs
have an increased risk of having a bleed or you had a big bleed in the last 3 months
have a serious wound, ulcer or bone fracture that isn’t getting better
have a problem absorbing nutrients
have a lesion in the lung called a cavitating lesion or cancer in your airways causing breathing difficulties
have a problem with your kidneys and need to have dialysis
have HIV, an active hepatitis B or hepatitis C infection, tuberculosis (TB) or a recent severe infection that needed treatment
can’t swallow tablets

Other
You can’t take part if the following apply. You:

have had a severe allergic reaction to atezolizumab, cabozantinib or docetaxel or anything they contain
have had a live vaccine in the last 4 weeks or might need one during the trial
are pregnant or breastfeeding

Trial design

This is a phase 3 trial. It is taking place worldwide. The researchers need 350 people to take part including at least 15 from the UK.

It is randomised trial. You are put into a group by a computer. Neither you nor your doctor will be able to decide which group you are in. There are 2 treatment groups. You have 1 of the following:

atezolizumab and cabozantinib
docetaxel

CONTACT 01 randomisation diagram

You have treatment for as long as it is working and the side effects aren’t too bad.

Atezolizumab and cabozantinib
You have atezolizumab as a drip into a vein. You have it once every 3 weeks.

Cabozantinib is a tablet. You take them once a day, every day.

Docetaxel
You have docetaxel as a drip into a vein. You have it once every 3 weeks.

Blood and tissue samples
The researchers ask you to give an extra tissue sample. They also ask to take some extra blood samples. Where possible, you have these at the same time as your routine blood tests.

The researchers use the samples to look for differences in substances called biomarkers Open a glossary item . This can help researchers to work out why treatment might work for some people and not for others.

You need to agree to give most of the samples in the trial. There are a few you don’t need to agree to if you don’t want to. The team can let you know more about this.

Hospital visits

You see a doctor and have some tests before you can take part in the trial. These include:

physical examination
heart trace
blood tests
urine tests
CT scan or MRI scan
bone scan

You may also need to give a tissue sample (biopsy Open a glossary item ).

During treatment you see the doctor every 3 weeks for a check up and blood tests.

You have a CT or MRI scan:

every 6 weeks in the first year and then
every 9 weeks until your cancer gets worse

When you finish treatment you see the doctor 1 month later. If your cancer hasn’t got worse you continue to have scans every 6 to 9 weeks. You have a final scan after about 6 weeks if your cancer gets worse.

Follow up
The team follow you up every 3 months when you finish treatment. You might see them at a routine hospital appointment or they may call you to see how you are getting on.

Side effects

The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.

Atezolizumab can affect the immune system. It may cause inflammation in different parts of the body which can cause serious side effects. They could happen during treatment, or some months after treatment has finished. Rarely, these side effects could be life threatening.

If you have any of these side effects, you should tell the doctor or nurse as soon as possible. You should tell them you are on or have been on an immunotherapy.

The most common side effects of atezolizumab are: