A trial looking at lurbinectedin and doxorubicin for small cell lung cancer (ATLANTIS)

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:

• are happy to take part in this trial (have given voluntary informed consent)
• have limited or extensive stage SCLC that has come back or spread to other parts of the body at least 30 days after the last treatment with a platinum chemotherapy  
• have satisfactory blood test results 
• are well enough to be up and about for at least half the day (performance status 0, 1 or 2) 
• are at least 18 years old  
• are willing to use reliable contraception during treatment and for 6 weeks afterwards if you are a woman and there is any possibility you could become pregnant
• are willing to use reliable contraception during treatment and for 4 months afterwards if you are a man and there is any possibility your partner could become pregnant

Who can’t take part
You cannot join this trial if any of these apply. 

Cancer related
You:

• have had more than 1 line of chemotherapy (chemotherapy regimen )
• have never had chemotherapy for SCLC with a platinum drug
• have cancer spread in your brain, unless it is stable, not causing symptoms and you are gradually reducing (tapering) the dose of steroids
• have limited stage SCLC, doctors think you can have local therapies such as prophylactic cranial radiotherapy and radiotherapy to the thorax, and you have declined them or completed before taking part in this trial
• have had lurbinectedin, topotecan or an anthracycline chemotherapy 
• have had anti cancer treatment in the last 3 weeks and you still have moderate side effects from it, apart from hair loss, a drop in the number of red blood cells (anaemia), tiredness and damage to the nerves that carry messages of temperature and pain to the brain (sensory neuropathy) 
• have had whole brain radiotherapy in the last 4 weeks (2 weeks if it was prophylactic cranial radiotherapy)
• are going to have radiotherapy to help with symptoms (palliative radiotherapy) within 4 weeks of starting treatment in this trial
• need to have surgery to treat a fracture caused by the cancer, or an operation to treat spinal cord compression  within 4 weeks prior to randomisation
• have had chemotherapy or radiotherapy for another cancer or have had no treatment at all (you will be able to take part it you have had surgery to remove the cancer more than 3 years ago, and there are no signs of the cancer coming back) 

Medical conditions

You:

• have an active infection or doctors think you have a higher risk of getting an infection 
• have had an infection caused by a fungus that needed treatment that reached your whole body (systemic treatment) in the past 12 weeks 
• have ongoing problems with your liver such as hepatitis B or hepatitis C
• have HIV
• have an irregular heartbeat (arrhythmia) that is causing you problems or cannot be controlled
• have heart problems such as angina that is not controlled, problems with the valves of your heart, congestive heart failure or you have had a heart attack in the last year
• needed oxygen therapy in the last 2 weeks
• have a build up of scar tissue in your lungs (fibrosis) or a condition called interstitial lung disease (ILD)

Other

• You are pregnant or breastfeeding