A trial of lurbinectedin and atezolizumab to improve treatment for small cell lung cancer (IMforte)

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 to have chemotherapy and atezolizumab (induction treatment) if all of the following apply. You:

• have small cell lung cancer that has spread beyond a single area that can be treated with radiotherapy. This is called extensive lung cancer .
• haven’t had treatment to the whole body (systemic treatment)  for extensive lung cancer 
• have cancer that the doctor can measure on a scan 
• have a sample of cancer tissue (a biopsy ) available for the team to do some tests on
• are fit and 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 treatment and for a period after if there is any chance you or your partner could become pregnant 
• won’t donate sperm during the trial and for a period after if you are male 
• are at least 18 years old

To have maintenance treatment the following must apply. You:

• have had 4 cycles  of carboplatin, etoposide and atezolizumab as your first treatment as part of this trial
• have cancer that shrunk or stayed the same after your first treatment 
• join a maintenance treatment group within 5 weeks of the last dose of atezolizumab, carboplatin and etoposide. Or you join a group within 9 weeks if you are having radiotherapy to prevent or reduce the chance of cancer cells spreading to the brain. 
• don’t have any side effects from past treatment or if you do they are mild. You can join if you have hair loss or other side effects that the trial team don’t think will affect you taking part. 
• have satisfactory blood test results 
• are fit and active but might not be able to do heavy physical work (performance status of 0 or 1)

Who can’t take part

Cancer related 
You can’t join the induction part of the trial if any of the following apply. You:

• have cancer that has spread to the brain or to the tissues surrounding your brain (leptomeningeal disease)
• have spinal cord compression  that hasn’t been treated or isn’t stable 
• are going to have radiotherapy to the chest to get rid of any remaining cancer cells 
• have had previous treatment with some types of immunotherapy. Your doctor will know which ones these are.
• have had lurbinectedin or trabectedin in the past 
• have had treatment to stimulate the immune system . This includes interferon in the last 4 weeks or if treatment hasn’t completely cleared your body.
• have pain that your cancer is causing and it isn’t controlled with medication 
• have had an experimental treatment in the month before joining this trial 
• have had another cancer that has got worse or needed treatment in the past 5 years unless it has a low chance of coming back. You can join if it was successfully treated non melanoma skin cancer , carcinoma in situ (CIS ) of the cervix, prostate cancer that hasn’t spread (localised prostate cancer), ductal carcinoma in situ (DCIS)  or early stage womb cancer

Medical conditions 
You can’t join the induction part of the trial if any of the following apply. You:

• have areas of fluid on the lung, in the tummy or around the heart that needs regular draining
• have high levels of calcium in the body that isn’t controlled with medication 
• have liver problems
• have scarring on the lungs or active inflammation of the lungs (pneumonitis ) 
• have had a heart attack in the last 3 months or a significant heart problem  that isn’t well controlled with medication. Your doctor checks your heart before you join the trial. 
• have HIV unless it is well controlled with medication, you are having treatment for a hepatitis B or hepatitis C infection or you have active tuberculosis (TB)
• have had treatment that damps down the immune system within a week of joining the trial. This is unless it was a low dose. 
• have had a stem cell transplant  with someone else’s cells or an organ transplant
• have any other medical condition that the trial team think will affect you taking part 

Other 
You can’t join the induction part of the trial if any of the following apply. You:

• are allergic to lurbinectedin, carboplatin, etoposide, atezolizumab or anything they contain
• have had a live vaccine  within 4 weeks of starting treatment or you might need one during the trial 
• are pregnant or breastfeeding