A trial of chemotherapy and immunotherapy for non small cell lung cancer (Skyscraper 06)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is comparing two combinations of treatment for non small cell lung cancer. The first treatment is chemotherapy, tiragolumab and atezolizumab. And the other is chemotherapy, pembrolizumab and a dummy drug.
It is for people:
- whose cancer has grown into surrounding tissues or elsewhere in the body
- who haven’t had chemotherapy or an
immunotherapy
More about this trial
You may have chemotherapy and a drug called pembrolizumab to treat non small cell lung cancer (NSCLC) that has spread. Cancer that has spread is called locally advanced or advanced (metastatic) cancer.
Pembrolizumab is an immunotherapy. It stimulates the to fight cancer. This can slow down or stop the growth of the cancer.
Doctors are always looking for ways to improve treatment for advanced lung cancer. In this trial they are looking at a new combination of treatment. It includes chemotherapy and 2 types of immunotherapies called tiragolumab and atezolizumab.
Atezolizumab and pembrolizumab work in a similar way. They block a protein to help the immune system to find and kill cancer cells. Tiragolumab is a new drug that blocks a different protein.
The chemotherapy drugs you have in this trial are pemetrexed with carboplatin or cisplatin. These are standard chemotherapy drugs used to treat non small cell lung cancer.
Some people in the trial have atezolizumab, chemotherapy and tiragolumab. And some have pembrolizumab, chemotherapy and a dummy drug ().
The main aims of the trial are to find out:
- which combination of treatment works best to slow cancer growth
- more about the side effects
- how treatment affects
quality of life
Who can enter
The following bullet points are a summary of 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 non small cell cancer that has spread into surrounding tissues and you can’t have surgery to remove it or the cancer has spread to another part of the body
- haven’t had treatment that reaches the whole body (
systemic treatment) , for example chemotherapy or immunotherapy. You may be able to take part if you had certain treatments before surgery with the aim to cure your cancer. Your doctor checks when you had this to see if you can take part.
- have a tumour sample available for the trial team to do some tests on or you are willing to give a new sample if this is possible
- may or may not have certain proteins (receptors) called PD-L1 on the surface of the cancer cells. Your doctor needs to know this and will check.
- have cancer that the doctor can see and measure on a scan
- are on a stable dose of medication to thin the blood if you take this
- have satisfactory blood test results
- 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)
- 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 a type of non small cell lung cancer called pulmonary lymphoepithelioma-like carcinoma. Your doctor will know this.
- have cancer that has both non small cell lung cancer cells and small cell cancer cells
- have a change (
mutation ) in the EGFR or ALK genes on the lung cancer cells
- have cancer that has spread to the brain or spinal cord that is causing symptoms, getting worse or hasn’t been treated
- have cancer that has spread to the thin layers of tissue that cover the brain and spinal cord (leptomeningeal metastases)
- have had treatment within 3 weeks for your cancer including
hormone treatment before starting trial treatment
- have had tiragolumab, atezolizumab or similar drugs in the past
- have a condition called
spinal cord compression that hasn’t been treated or isn’t stable
- have pain from your cancer that isn’t controlled with medication
- have had another cancer that has got worse or needed treatment in the past 5 years. This is apart from successfully treated
non melanoma skin cancer , carcinoma in situ (
CIS) of the cervix, early prostate cancer,
DCIS of the breast or early
womb cancer
- have had an experimental drug in the last month
Medical conditions
You cannot join this trial if any of these apply. You:
- have areas of fluid on the lung, heart or tummy that need frequent draining
- have high levels of
calcium in the blood and treatment for this isn’t working
- have or have had an
autoimmune disease or a problem with your
immune system . This is apart from certain ones. Your doctor checks this.
- have scarring of the lungs (
pneumonitis ) that shows up on a scan unless you had radiotherapy to that area
- have a severe liver problem and it doesn't work well. Your doctor checks this.
- have had a heart attack or stroke in the last 3 months or a significant
heart problem 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 month. This is apart from surgery to diagnose your cancer.
- have had a
stem cell transplant with someone else’s cells or an
organ transplant in the past
- have had treatment to stimulate the
immune system . This includes interferon in the last 2 weeks or if treatment hasn’t completely cleared your body.
- have had treatment that damps down the immune system or you might need to start this treatment. This includes
steroids within 2 weeks of starting trial treatment unless it was a low dose.
- have a problem with your hearing if you are due to have cisplatin
- have moderate numbness and tingling in your hands or feet from past side effects if you are having cisplatin
- have HIV, an active hepatitis B or hepatitis C infection, active tuberculosis (TB), Epstein Barr virus (EBV) or any severe infection that needs treatment
- have another medical condition or mental health problem that your doctor or the trial team think could affect you taking part
Other
You can’t join this trial if any of these apply. You:
- have had a
live vaccine in the last 4 weeks or you might need one during the trial. The current approved COVID-19 vaccines are not live.
- are allergic to tiragolumab, atezolizumab, pembrolizumab or anything they contain
- are pregnant or breastfeeding
Trial design
This phase 2 trial is taking place worldwide. The team need to find 200 people to take part including 15 from the UK.
It is a 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.
It is a double blind trial. This means neither you nor your doctor will know which treatment group you are in. But they can find this out if necessary.
You have 1 of the following:
- tiragolumab, atezolizumab and chemotherapy
- pembrolizumab, a dummy drug and chemotherapy
Everyone has treatment as long as it is working and the side effects aren’t too bad.
Tiragolumab, atezolizumab and chemotherapy
You have treatment in cycles. Each 3 week period is a . You have all your treatment as a drip into a vein.
On day 1 of each cycle you have:
- tiragolumab
- atezolizumab
- pemetrexed chemotherapy
- carboplatin or cisplatin chemotherapy
Carboplatin or cisplatin will stop after the first 4 cycles.
Pembrolizumab, a dummy drug and chemotherapy
You have treatment in cycles. Each 3 week period is a cycle of treatment. You have all your treatment as a drip into a vein.
On day 1 of each cycle you have:
- pembrolizumab
- a dummy drug (
placebo )
- pemetrexed chemotherapy
- carboplatin or cisplatin chemotherapy
Carboplatin or cisplatin will stop after the first 4 cycles.
Follow up
When you finish treatment you see the doctor 1 month later for a check up.
The team then follow you up every 3 months.
You might see them at a routine hospital appointment or they may call you to see how you are getting on.
Samples for research
The team ask you to give some extra blood samples. Where possible, you have these at the same time as your routine blood tests.
They also ask you to give an extra tissue sample ( if your cancer gets worse. You don’t have to agree to this if you don’t want to. You can still take part in the trial.
They plan to use the samples to:
- see how well treatment is working
- look for substances called
biomarkers to help work out why treatment might work for some people and not for others
Quality of life
The trial team ask you to fill out a questionnaire:
- before you start treatment
- 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
Hospital visits
You see the doctor and have tests before you can take part. These include:
• a physical examination
• blood tests
• urine tests
• heart trace ()
• CT scan or MRI scan
You may also need to have a bone scan.
You have your treatment in the hospital outpatient department. At each visit you have a check up and blood tests. The hospital visits can take between 1 hour and 8 hours.
You have a CT scan or an MRI scan:
- every 6 weeks for about a year and then
- every 9 weeks until your cancer gets worse
Mobile (home) visits
There is the option of using mobile nursing in this study. Instead of coming to the hospital for all visits, a nurse can visit you at your home or at another suitable location to make it easier for you to take part in this study.
The nurse can:
- check your blood pressure, temperature and heart rate
- take blood samples
- assess any side effects or changes in your health
- check any changes in your medications
The average mobile nursing visit is 30 to 90 minutes. You don’t have to agree to the nursing visits if you don’t want to.
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, atezolizumab and pembrolizumab can affect the immune system. They may cause inflammation in different parts of the body. This 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 tell your doctor or nurse as soon as possible. And 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:
- an allergic reaction while having tiragolumab or the day after. This can include fever, chills, shortness of breath, sickness, and changes in blood pressure.
- inflammation where the cancer is
- inflammation in other parts of the body
- an increased risk of infection
You may have some medication before tiragolumab to reduce the risk of having a reaction to the infusion.
Your doctor or a member of the trial team talk to you about the treatment you are having and possible side effects before you agree to take part.
The most common side effects of atezolizumab are:
- tiredness (fatigue)
- joint, muscle or bone pain
- lack of energy
- loss of appetite
- diarrhoea
- shortness of breath
- urine infections
- cough
- skin rash or itchy skin
- feeling or being sick
- fever
- headache
We have information about the following drugs and their side effects:
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 Colin Lindsay
Supported by
Roche
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040