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

Cancer type:

Lung cancer
Secondary cancers
Small cell lung cancer

Status:

Open

Phase:

Phase 3

This trial is looking at adding lurbinectedin to atezolizumab to help treat small cell lung cancer (SCLC). 

It is for people whose cancer has spread within the chest or to other parts of the body. This is called extensive disease.

More about this trial

You may have chemotherapy and atezolizumab as the first treatment for extensive small cell lung cancer. This is called induction treatment. The aim is to shrink the cancer as much as possible. 

You may then continue to have more atezolizumab on its own. This is called maintenance treatment. The aim is to control the cancer for as long as possible. 

The usual chemotherapy drugs you might have as your first treatment are carboplatin and etoposide. Atezolizumab is an immunotherapy. It helps your immune system Open a glossary item to find and kill cancer cells. 

Researchers are looking at ways to improve treatment. In this trial they are looking at a chemotherapy drug called lurbinectedin. It is a newer chemotherapy. Doctors think that adding it to maintenance atezolizumab could help to control the cancer for longer. 

The main aims of the trial are to find out:

  • if having lurbinectedin alongside maintenance atezolizumab works for people with SCLC
  • how safe the combination is
  • more about the side effects  
  • how treatment affects quality of life Open a glossary item

Who can enter

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 Open a glossary item.
  • haven’t had treatment to the whole body (systemic treatment) Open a glossary item for extensive lung cancer 
  • have cancer that the doctor can measure on a scan 
  • have a sample of cancer tissue (a biopsy Open a glossary item) 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 Open a glossary item 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 Open a glossary item 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 Open a glossary item. 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 Open a glossary item, carcinoma in situ (CIS Open a glossary item) of the cervix, prostate cancer that hasn’t spread (localised prostate cancer), ductal carcinoma in situ (DCIS) Open a glossary item 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 Open a glossary item
  • have scarring on the lungs or active inflammation of the lungs (pneumonitis Open a glossary item
  • have had a heart attack in the last 3 months or a significant heart problem Open a glossary item 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 Open a glossary item with someone else’s cells or an organ transplant Open a glossary item
  • 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 Open a glossary item within 4 weeks of starting treatment or you might need one during the trial 
  • are pregnant or breastfeeding
You can’t have atezolizumab and lurbinectedin (maintenance treatment) if certain exclusion conditions apply. Speak to your doctor or research nurse if you want to find out more about the specific entry conditions for the maintenance part of the trial.

 

 

Trial design

This phase 3 trial is taking place worldwide. There are 2 stages of treatment. The team need about:

  • 690 people to join the first stage of the trial (induction treatment)
  • 450 to then go on and have more treatment (maintenance treatment)

This includes about 41 people from the UK. 

First treatment (induction treatment)
You have treatment in cycles. Each 3 week period is a cycle of treatment.  Open a glossary item On the first day of each cycle you have:

You also have etoposide on days 2 and 3 of each treatment cycle. You have atezolizumab and carboplatin as a drip into a vein. Etoposide is a capsule that you swallow or you have it as a drip into a vein.

The first treatment stage takes 12 weeks in total. 

You then have some tests check if you are suitable for maintenance treatment.

Ongoing treatment (maintenance treatment)
You can join the maintenance part of the trial if your cancer doesn’t get worse after induction treatment. You can’t join this part if your cancer gets worse. Your doctor will talk to you about other treatment options. 

This part of the trial is randomised. There are 2 treatment groups. A computer puts you into a group. Neither you nor your doctor can decide which group you are in. 

You have one of the following:

  • atezolizumab and lurbinectedin
  • atezolizumab on its own (standard treatment)

You have treatment in cycles. Each 3 week period is a cycle of treatment.
You have treatment once every 3 weeks. You have all your treatment as a drip into a vein. You have it for as long as it is working and the side effects aren’t too bad.

Blood and tissue samples 
The researchers ask you to give some extra tissue samples. They also ask to take some extra blood samples. Where possible, you have these at the same time as your routine blood tests.

They plan to use the samples to:

  • see how well the treatment is working 
  • look at genes Open a glossary item to understand more about small cell lung cancer 
  • look for substances called biomarkers Open a glossary item to help work out why treatment might work for some people and not for others

You can say no to giving the tissue samples. It won’t affect you taking part in the rest of the trial.

Quality of life 
The trial team ask you to fill out a questionnaire:

  • before you start treatment
  • at set times during treatment

The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

You see the doctor and have tests before you can take part. These include:

Your doctor repeats these tests to check you are suitable to have maintenance treatment.  

You have all your treatment at the hospital on the day care ward. The visits to have induction treatment take about 3 to 6 hours each time. The visits to have maintenance treatment take about 3 to 6 hours each time. There is a chance you might be at the hospital for longer. 

During treatment you have a check up and blood tests once every 3 weeks. 

You have a CT scan every:

  • 6 weeks in the first year 
  • 9 weeks in the second year 
  • 3 months until the end of the trial

You stop having the trial scans if your cancer gets worse. 

Follow up 
You see the team 1 month after you finish treatment. After that you see or speak with a member of the team every 3 months. This may be at a hospital visit or they may call you.

Side effects

The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better. 

Atezolizumab can affect the immune system. It may cause inflammation in different parts of the body. This can cause serious side effects. They could happen during treatment, or some months after treatment has finished. Rarely, these side effects could be life threatening. 

Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for.
 
If you have any of these side effects tell your doctor or nurse as soon as possible. You should tell them that you are on or have been on an immunotherapy.

The most common side effects of atezolizumab include:

Lurbinectedin is a newer drug so there might be some side effects we don’t know about yet. The most common side effects we know about so far include:

  • a drop in the number of blood cells causing an increased risk of infection, bruising and bleeding, tiredness and breathlessness
  • tiredness (fatigue)
  • liver changes 
  • feeling or being sick
  • diarrhoea 
  • loss of appetite 
  • kidney changes 

We have more information about:

Location

Bangor
Blackpool
Edinburgh
Hull
Leeds
Leicester
London
Manchester

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Raffaele Califano

Supported by

Roche

Freephone 0808 800 4040

Last review date

CRUK internal database number:

18141

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Cara took part in a clinical trial

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"I am glad that taking part in a trial might help others on their own cancer journey.”

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