A trial of tiragolumab, atezolizumab and chemotherapy for small cell lung cancer (Skyscraper 02)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Lung cancer

Secondary cancers

Small cell lung cancer

Status:

Closed

Phase:

Phase 3

This trial is looking at adding tiragolumab to atezolizumab and chemotherapy for small cell lung cancer.

It is for people:

whose cancer has spread within the chest or elsewhere in the body. This is called extensive disease.
who haven’t had chemotherapy

More about this trial

You may have chemotherapy and atezolizumab as the first treatment for extensive small cell lung cancer. Researchers are trying to improve treatment. In this trial they are adding a drug called tiragolumab.

Tiragolumab is a new drug. It is type of immunotherapy. It blocks a protein in the body that stops the immune system Open a glossary item from working properly. Blocking this protein helps the immune system to find and fight cancer cells.

Atezolizumab is another type of immunotherapy drug. It works in a similar way to tiragolumab to stimulate the immune system. But it blocks a different protein.

The chemotherapy drugs you have in this trial are called carboplatin and etoposide. These are standard chemotherapy drugs used to treat small cell lung cancer.

In this trial some people have atezolizumab, chemotherapy and tiragolumab. And some people have atezolizumab, chemotherapy and a dummy drug (placebo Open a glossary item ).

The main aims of the trial are to find out:

if adding tiragolumab to atezolizumab and chemotherapy improves treatment
more about the side effects
how treatment affects quality of life

Who can enter

The following bullet points list the main 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 extensive stage small cell lung cancer and you haven’t had chemotherapy but you may have had chemoradiotherapy with the aim to cure your cancer. The team check when you had chemoradiotherapy to see if you are suitable to join the trial.
have cancer that your doctor can see and measure on a scan
are taking a stable dose of medication to thin the blood such as warfarin if you are on this treatment
are well enough to carry out all your normal activities, but might not be able to do heavy physical work (performance status of 0 or 1)
have a sample of tissue (biopsy ) available for the team to do some tests on
have satisfactory blood test results
are willing to use reliable contraception during treatment and for a period of time after if there is any chance you or your partner could become pregnant
are at least 18 years old

Who can’t take part

You cannot join this trial if any of these apply.

Cancer related
You:

have cancer that has spread to the brain or spinal cord that is causing symptoms or is getting worse
have a condition called spinal cord compression that hasn’t been treated or isn’t stable
have had any other cancer within 5 years of joining the trial apart from carcinoma in situ (CIS ) of the cervix, non melanoma skin cancer , prostate cancer that hasn’t spread or DCIS that has been successfully treated with surgery
have already had tiragolumab, atezolizumab or similar drugs in the past
are having treatment with an experimental drug as part of another clinical trial

Medical conditions
You can’t take part if any of the following apply.

You:

have or have had an autoimmune disease or a problem with your immune system. For example you have rheumatoid arthritis, multiple sclerosis or lupus. You may be able to take part if you have type 1 diabetes, thyroid problems that are controlled by medication or certain skin conditions.
take drugs to stimulate the immune system that may include the drugs interferon or interleukin . You had these within 4 weeks of being put into a treatment group.
have taken drugs that damp down your immune system (immunosuppressants) such as steroids in the week before being put into a treatment group. You might still be able to take part if it was a very small dose, a cream, or an inhaler.
have fluid on the lung or a collection of fluid in the tummy (abdomen) that needs regular draining
have liver disease or damage to your liver
have an infection including HIV, hepatitis B, hepatitis C, active tuberculosis (TB), Epstein Barr virus (EBV) or you might have it or a severe infection that needs treatment when you are put into a treatment group
have scarring of the lungs that shows up on a scan unless you had radiotherapy to that area
have had a heart attack or stroke in the last 3 months or another heart problem that needs treatment
have had major surgery for another condition in the month before joining a treatment group in this trial or you are to have major surgery
have had a bone marrow transplant or an organ transplant
have any other medical condition or mental health problem that the trial team think might affect you taking part in the trial

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

have had a live vaccine within 4 weeks of joining a treatment group or you need one during the trial or for a period of time after
are allergic to any of the treatments in the trial or anything they contain
are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. The researchers hope to find 470 people to take part including 13 people from the UK.

It is a randomised trial. There are 2 treatment groups. Neither you nor your doctor can decide which group you are in.

You have 1 of the following:

atezolizumab, chemotherapy and tiragolumab
atezolizumab, chemotherapy and a dummy drug

skyscraper_02.png

You have treatment in cycles. Each 3 week period is a cycle of treatment Open a glossary item .

Initial treatment (induction treatment)
For the first 4 cycles of treatment you have treatment as follows. On the first day of each cycle you have:

atezolizumab
tiragolumab or the dummy drug
carboplatin and etoposide

You have treatment once every 3 weeks. You also have etoposide on days 2 and 3 of each treatment cycle.

Cycle 1 to 4

Day 1

You have atezolizumab

You have tiragolumab or the dummy drug

You have carboplatin and etoposide

Day 2

You have etoposide

Day 3

You have etoposide

Ongoing treatment (maintenance treatment)
From cycle 5 onwards you don’t have any more chemotherapy. You have treatment as follows. On the first day of each cycle you have:

atezolizumab
tiragolumab or the dummy drug

You have treatment once every 3 weeks.

Cycle 5 onwards

Day 1

You have atezolizumab

You have tiragolumab or the dummy drug

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

Quality of life
The trial team ask you to fill out a questionnaire before you start treatment and at set times during treatment. The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.

Blood and tissue samples
The researchers ask you to give 2 extra tissue samples. 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 researches work out why treatment might work for some people and not for others.

You don’t have to give these samples if you don’t want to. You can still take part in the trial.

Hospital visits

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

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

You have treatment at the hospital in the outpatient department. Each treatment visit takes between 4 and 6 hours. This might be slightly longer for the first cycle of treatment. You may also have some overnight stays. The team tell you when these happen.

You see the trial doctor once every 3 weeks for a check up and blood tests.

You have a CT scan, MRI scan or bone scan:

every 6 weeks for a year and then
every 9 weeks until your cancer gets worse

You see the team 1 month after you finish treatment. After that you see or speak with a member of the team every 3 months. This may be at a hospital visit or they may call 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.

Tiragolumab and atezolizumab can affect the immune system. They 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 that you are on or have been on an immunotherapy.

Tiragolumab is a new drug so there may be side effects we don’t know about. The side effects we know about so far include: