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

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 . You need to have finished this 1 to 42 days before randomisation . 
• have had a certain dose of radiotherapy using either intensity modulated radiotherapy (IMRT ) or 3D conformal radiotherapy . You doctor can tell you about this.
• have had a whole body PET-CT scan  within 42 days before starting chemoradiotherapy
• have a cancer tissue sample (biopsy ) 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 ) EGFR  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 , early  prostate cancer, DCIS  or early womb cancer
• have had previous treatment with some types of immunotherapy . 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 . 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  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