A trial of MK-7684A and chemotherapy for small cell lung cancer (KeyVibe-008)

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 extensive stage small cell lung cancer that is newly diagnosed
• have a large area of cancer, and or more than one area of cancer in the lung and these cannot be treated with radiotherapy. Or it has spread to other parts of the body.
• have cancer that the doctor can measure on a scan 
• have a sample of tissue (biopsy)  available for the trial team to test or you are willing to give a new sample
• are fully active but might not be able to do heavy physical work (performance status of 0 or 1)
• have satisfactory blood test results
• are willing to use reliable contraception during the trial and for a period 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 that has spread to the brain, tissues around the brain or to the spinal cord unless it has been treated and is stable. In some cases you might be able to take part if you haven’t had treatment for cancer spread to the brain. Your doctor can tell you more about this.
• have already had treatment for small cell lung cancer. This doesn’t include having palliative  radiotherapy.
• need to have another cancer treatment for small cell lung cancer while you are in this trial. This might not apply if you are going to have radiotherapy to a single area of cancer or to the brain.
• are taking an experimental treatment or using a device as part of a clinical trial in the 4 weeks before joining this trial 

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

• have a problem with how your immune system  works or you are having long term steroids unless it is a low dose
• have another cancer that is getting worse or needed treatment in the last 3 years. You can take part if you had non melanoma skin cancer  or carcinoma in situ (CIS ) that has been successfully treated.
• have an autoimmune condition  that needed treatment in the last 2 years apart from certain ones. Your doctor will know this.
• had or have scarring of the lung tissue or inflammation of the lung that needs treatment
• have a problem with your nerves caused by cancer. This can cause problems with coordination, changes to your senses, memory or thinking skills, or sleep problems. Your doctor will know about this.
• have HIV, you have had hepatitis B or an active hepatitis C infection or you have any other infection that needs treatment 
• have had a stem cell transplant with someone else’s cells (an allogeneic transplant ) or an organ transplant
• have had major surgery in the 3 weeks before you start trial treatment or you have side effects from past treatments that aren’t getting better
• have areas of fluid in the body that are causing symptoms or you have fluid on the lung. You might be able to join if you have had treatment for this and it isn’t getting worse.
• have any other medical condition or mental health problem that isn’t well controlled with medication that the trial team think could affect you taking part

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

• are allergic to the trial treatments or anything they contain
• have had a live vaccination  in the 30 days before the first dose of trial treatment
• have a problem with drugs or alcohol 
• are pregnant or breastfeeding