A trial looking at volrustomig and chemotherapy for non small cell lung cancer (eVOLVE-Lung 02)

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 lung cancer (NSCLC) that has spread to another part of the body and you can’t have surgery or radiotherapy with the aim to cure it
• had a sample of tissue (biopsy ) taken that the team can access or if this is not available you are willing to have a fresh sample taken. The team use the sample to assess whether your cancer cells have the PD-L1 protein. To take part less than half (less than 50%) of the cancer cells must have the PD-L1 protein.
• must have a suitable area of cancer seen on a scan that the doctor can measure. Your doctor will know about this. 
• can look after yourself but might not be able to do heavy physical work (performance status 0 or 1) in the 2 weeks before joining the trial. And your performance status must not get worse before you are put into a treatment group (randomised). Your doctor will assess you for this at these times. 
• have satisfactory blood test results
• weigh more than 35 kg (5st 7lb) when you join the trial and when you are randomised
• must be willing to use reliable contraception during treatment and for a 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

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

• have cancer cells with certain gene changes (mutations ) such as EGFR, ROSI or BRAF. Your doctor will know about this. 
• have NSCLC mixed with small cell lung cancer, a type of NSCLC called sarcomatoid carcinoma or a rare type of NSCLC
• have spinal cord compression
• have cancer spread to the brain. This is unless it has been treated, is stable with no symptoms. And you haven’t needed steroids for at least 2 weeks before the start of the trial treatment. If you had whole brain radiotherapy it must have been completed at least 2 weeks before joining the trial.
• have another cancer. This is apart from successfully treated non melanoma skin cancer , carcinoma in situ . Or you had cancer that was treated with the aim to cure and there hasn't been any sign of it for more than 2 years and there is a low risk of it coming back.
• have already had an immunotherapy including cancer vaccines . Your doctor will know this. 
• have already had treatment that reaches your whole body (systemic treatment) such as chemotherapy to treat the cancer spread. You could join if you had a platinum drug such as carboplatin or you had chemoradiotherapy as long as your cancer came back more than a year ago after your last treatment. 
• are not able to have platinum drugs
• have ongoing moderate to severe side effects apart from hair loss
• are currently having cancer treatment
• have had an experimental drug or used a device as part of another clinical trial within the past year
• have radiotherapy to relieve symptoms (palliative radiotherapy) within 2 weeks of starting trial treatment for a small area of cancer. For a large area or if it includes more than 30% of the bone marrow it is within 4 weeks. 
• are taking herbal preparations or other natural substances as treatment for, or to prevent, cancer that might affect you taking part in the trial. Your doctor will know about this.

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

• have an infection that is active or not well controlled by medication such as tuberculosis (TB), HIV, hepatitis A, hepatitis B, hepatitis C. You can ask your doctor about this.
• have heart problems such as a heart attack in the past year, uncontrolled chest pain (angina) or any other heart problem that could affect you taking part. You are taking medication for a type of heart problem called Torsades de pointes.
• have, or have had, an autoimmune disease apart from certain ones such as vitiligo and hair loss. Your doctor will know about any other ones. 
• have, or have had, an immune system that isn’t working very well
• have, or have had, an inflammation disorder such as Crohn’s disease, rheumatoid arthritis or pneumonia 
• are taking medication such as steroids that damp down your immune system or you have taken such medication within 2 weeks of starting treatment. This is apart from inhalers, creams, nasal sprays and steroid injections to one place on the body.
• have major surgery or a major injury (trauma) within 4 weeks of starting trial treatment. Or you are still recovering from surgery. 
• have previously been randomised or treated in a clinical trial using volrustomig. This is regardless of whether you had volrustomig or not.
• have any other medical condition, mental health problem or social situation that could affect you taking part  

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

• are allergic or sensitive to any of the treatment used in the trial or any of their ingredients
• have a live vaccine within 30 days of starting treatment. You shouldn’t have a live vaccine while having treatment or for up to 30 days after the last treatment. The COVID-19 and seasonal flu vaccines aren’t live vaccines.
• are pregnant or breastfeeding