A trial of atezolizumab and tiragolumab for lung cancer (SKYSCAPER-03)

Cancer type:

Lung cancer
Non small cell lung cancer

Status:

Open

Phase:

Phase 3

This trial is comparing two treatments for non small cell lung cancer. The first treatment is atezolizumab and tiragolumab. The other treatment is durvalumab. 

It is for people with non small cell lung cancer that:

  • is locally advanced Open a glossary item
  • can’t be removed by surgery
  • and hasn’t got worse following chemoradiotherapy Open a glossary item

More about this trial

Chemoradiotherapy is a combination of chemotherapy and radiotherapy. After chemoradiotherapy you might have durvalumab to strengthen the effect of the chemoradiotherapy. 

Durvalumab is an immunotherapy Open a glossary item. It works by stimulating the immune system Open a glossary item to fight cancer. This can slow down or stop the growth of the cancer. 

Atezolizumab and tiragolumab are also immunotherapies.

In this trial researchers want to compare durvalumab with atezolizumab and tiragolumab. Half the people taking part will have durvalumab and the other half will have atezolizumab and tiragolumab. 

The aims are to find out:

  • how atezolizumab with tiragolumab compares with durvalumab on its own
  • how the combination of atezolizumab and tiragolumab affects quality of life Open a glossary item

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 stage 3 non small cell lung cancer (NSCLC) that is locally advanced and cannot be removed by surgery
  • are having or had chemotherapy and radiotherapy together (chemoradiotherapy)
  • have had at least 2 cycles of chemoradiotherapy which included a platinum drug Open a glossary item. You need to have finished this 1 to 42 days before randomisation Open a glossary item
  • have had a certain dose of radiotherapy using either intensity modulated radiotherapy (IMRT Open a glossary item) or 3D conformal radiotherapy Open a glossary item. You doctor can tell you about this.
  • have had a whole body PET-CT scan Open a glossary item within 42 days before starting chemoradiotherapy
  • have a cancer tissue sample (biopsy Open a glossary item) that the trial team can request
  • have satisfactory blood test results
  • are active but might not be able to do heavy physical work (performance status 0 or 1)
  • are willing to use contraception while having the trial treatment and for up to 5 months after if 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 had NSCLC before
  • have cancer that has the gene changes (mutations Open a glossary item) EGFR Open a glossary item or ALK
  • have areas of fluid on the lung (pleural effusions), you might be able to join the trial if the areas are too small to drain. Your doctor can tell about this
  • have cancer that has spread to another part of the body
  • have cancer that has got worse while having chemoradiotherapy or after finishing treatment
  • still have moderate to severe side effects from your chemoradiotherapy
  • are having another cancer treatment
  • have had another cancer in the past 5 years apart from certain types such as successfully treated non melanoma skin cancer Open a glossary item, early Open a glossary item prostate cancer, DCIS Open a glossary item or early womb cancer
  • have had previous treatment with some types of immunotherapy Open a glossary item. You doctor will know which ones these are.
  • have ongoing side effects from an immunotherapy that is caused by the immune system
  • are taking part in another clinical trial or still being followed up as part of a clinical trial

Medical conditions 
You cannot join this trial if any of these apply. You:

  • have an autoimmune disease Open a glossary item. You can still take part if you have certain autoimmune diseases. Your doctor can tell you about this.
  • have lung damage or inflammation of the lungs
  • have active tuberculosis (TB)
  • have HIV, hepatitis B or hepatitis C
  • have liver disease such as an active virus, cirrhosis or damage caused by alcohol
  • have a heart attack or stroke within 3 months of starting treatment
  • have other heart problems such as irregular heartbeat or chest pain (angina)
  • have major surgery within 4 weeks of starting treatment or might need surgery during the trial
  • have a severe infection within 4 weeks of starting treatment
  • have antibiotics within 2 weeks of starting treatment unless you take them to prevent an infection such as a urine infection
  • have a stem cell transplant using someone else’s stem cells (allogeneic transplant)
  • have had an organ transplant
  • have medication that affects the immune system within 2 weeks of starting treatment
  • are allergic to the treatment used in the trial, any of their ingredients or how they are made
  • have any other medical condition or mental health problem that your doctor or the trial team think could affect you taking part

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

  • have a live vaccine Open a glossary item within 4 weeks of starting treatment, or you might need to have a live vaccine during treatment or within 5 months after finishing treatment. This doesn’t include the COVID-19 vaccines as they are not a live vaccine.
  • are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. The team need 800 people worldwide to join with 32 people from the UK.

It is a randomised trial. There are 2 groups. Neither you nor your doctor can choose which group you are in. The groups are:

  • durvalumab
  • atezolizumab and tiragolumab

You have durvalumab as a drip into a vein. You have it every 2 or 4 weeks.

You have atezolizumab and tiragolumab as a drip into a vein. You have them every 4 weeks. 

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

Questionnaires
You fill in questionnaires:

  • before starting treatment then
  • every 8 weeks while having treatment
  • then at 3 months and 6 months after

If you stop treatment early and your cancer hasn’t got worse you fill in the questionnaires at every clinic visit. You do this until your cancer gets worse. 

The questions ask about:

  • any symptoms you have
  • any side effects you might have
  • your general health
  • your daily activities

These are quality of life questionnaires

Research samples
You give blood samples before you start treatment and several times during the trial. 

The trial team will ask for a sample of tissue (biopsy Open a glossary item) when your cancer gets or when it improves as along as it is safe to do so. You don’t have to agree to have this biopsy taken. You can still take part in the trial.

They will use these samples to:

  • look for substances that might tell them how well the treatment is working. These substances are called biomarkers. Open a glossary item
  • find out more about NSCLC

Hospital visits

You see the doctor to have tests before taking part. These tests include:

  • a physical examination
  • blood tests
  • heart trace (ECG Open a glossary item)
  • CT scan or an MRI scan

You see the doctor before each treatment to see how you are and for bloods. 

You have a scan every:

  • 8 weeks for 48 weeks then
  • every 3 months till your cancer gets worse

You see the doctor within a month of finishing treatment. Your doctor will then tell you how often they want to see you.

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.

Durvalumab, atezolizumab and tiragolumab can affect the immune system. They may cause inflammation in different parts of the body. This can cause serious side effects. These side effects could happen during treatment, or some months after treatment has finished. Rarely, they can be life threatening.

Tell your doctor or nurse as soon as possible if you have any of these side effects. And tell them that you are having or have had an immunotherapy. 

 

Tiragolumab has not been used much in people. So there may be side effects we don’t know about. The side effects of tiragolumab we do know about are:

  • a reaction that can happen while you are having tiragolumab or in the day after. This is called an infusion reaction. Signs include a high temperature (fever), chills, shortness of breath, feeling sick (nausea) and changes in blood pressure.
  • inflammation where the cancer is
  • inflammation in other parts of the body such as the lungs, liver, eyes, skin, gut, kidneys, muscles and blood vessels
  • a drop in the number of a type of white blood cells Open a glossary item called lymphocytes Open a glossary item

The most common side effects of atezolizumab are:

  • tiredness and lacking energy (fatigue)
  • loss of appetite
  • diarrhoea
  • shortness of breath due to low levels of oxygen in the blood
  • cough
  • urine infection
  • feeling or being sick
  • itchiness, rash, dry skin
  • headache
  • high temperature (fever)
  • muscle, bone and stomach (abdominal) pain
  • chills and flu-like symptoms
  • difficulty swallowing
  • increased liver enzymes in the blood
  • decreased amount of potassium and sodium in the blood
  • low blood pressure (hypotension)
  • an underactive thyroid (hypothyroidism Open a glossary item)
  • stuffy nose
  • inflammation of the lungs and liver
  • a drop of platelets Open a glossary item in the blood causing increased risk of bruising and bleeding
  • a reaction while having atezolizumab (infusion reaction)
  • an allergic reaction 
  • a change to the way the kidneys work
  • pain at the back of the throat
  • an increased level of sugar in the blood

We have more information about atezolizumab and information about durvalumab and its side effects

Your doctor or a member of the trial team will talk to you about the treatment you are having and possible side effects before you agree to take part.

Location

Birmingham
Cambridge
Glasgow
Huddersfield
Leicester
London
Maidstone
Nottingham
Sheffield

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 Jonathan Hicks

Supported by

Roche

Freephone 0808 800 4040

Last review date

CRUK internal database number:

17227

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.”

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