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

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Lung cancer
Small cell lung cancer

Status:

Closed

Phase:

Phase 3

This trial is for people with small cell lung cancer that has come back or spread to other parts of the body after treatment with either:

  • a platinum chemotherapy
  • a combination of chemotherapy drugs that contain a platinum drug

Platinum chemotherapy includes the drugs cisplatin and carboplatin.

More about this trial

Chemotherapy with a platinum drug Open a glossary item is a treatment for small cell lung cancer (SCLC). But sometimes the cancer comes back, or spreads to other parts of the body. This is called progressive disease. 

You usually have more chemotherapy for progressive SCLC. You can have 1 of the following (but these are not the only treatments you can have): 

  • a chemotherapy drug called topotecan
  • a combination of chemotherapy drugs called CAV (cyclophosphamide, doxorubicin and vincristine)

This is the standard treatment Open a glossary item.

But doctors are looking for new ways to help people in this situation. In this trial, they are looking at a new type of chemotherapy drug called lurbinectedin (PM01183). Doctors want to find out if having lurbinectedin alongside another chemotherapy called doxorubicin, is better than the standard treatment. 

Everyone taking part in this trial has 1 of the following: 

  • doxorubicin and lurbinectedin 
  • standard treatment (either topotecan or CAV) 

The main aims of this trial are to: 

  • find out how well lurbinectedin and doxorubicin work as a treatment 
  • learn more about the side effects
  • learn more about people’s quality of life Open a glossary item
  • find out what happens to lurbinectedin in your body (pharmacokinetics Open a glossary item

Who can enter

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 Open a glossary item)
  • 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  Open a glossary item
  • 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 Open a glossary item within 4 weeks prior to randomisation Open a glossary item
  • 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

Trial design

This is an international phase 3 trial. Researchers hope that around 600 people will take part. 

This trial is randomised. The people taking part are put into 1 of the following groups by a computer:

  • doxorubicin and lurbinectedin 
  • standard treatment (either topotecan or CAV)

Neither you nor your doctor will be able to decide which group you are in. 

study diagram

Doxorubicin and lurbinectedin 
You have doxorubicin and lurbinectedin as a drip into a vein, every 3 weeks. It takes about an hour each time you have it. You can have up to 10 cycles of treatment (about 7 months). 

After 7 months, you may be able to continue to have lurbinectedin alone, for as long as your cancer stays the same, doesn’t get worse or gets better (doctors call this partial response Open a glossary item or complete response Open a glossary item). Your doctor will tell you more about this. 

Standard treatment
You have either:

  • topotecan
  • cyclophosphamide, doxorubicin, vincristine (CAV)

Your doctor can tell you which treatment is better for you. 

You have all drugs as a drip into a vein. How often you have them depends on the treatment you have. Your doctor can tell you more about this.   

Quality of life 
Everybody taking part completes quality of life questionnaires before starting treatment and then:

  • every 6 weeks during treatment
  • at the end of treatment 

The questionnaires ask about how you have been feeling and what side affects you have had.

Blood tests 
You have some extra blood tests if you are in the doxorubicin and lurbinectedin group. The researchers want to find out what happens to lurbinectedin in the body. 

You have the extra blood tests at set times during the trial. You might also have a pharmacogenetics test Open a glossary item. Your doctor can tell you more about this.

Hospital visits

You see a doctor and have some tests before taking part. These tests might include: 

  • a physical examination
  • blood tests
  • urine test
  • heart trace (ECG Open a glossary item) and heart ultrasound (ECHO) Open a glossary item
  • a CT scan or MRI scan

During treatment, you see a doctor every 3 weeks. You have a physical examination, blood tests and a heart trace at set times during the trial.

You have a CT scan or MRI scan every 6 weeks. This continues for as long as your cancer stays the same, does not get worse or gets better. You stop having treatment if your cancer gets worse.

When you stop treatment, you see the trial team after a month. Then the trial team will tell you how often you see them. It depends on the reason why you stopped having treatment.

Side effects

The trial team monitor you during the time you have treatment and you have a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start the trial. 

The most common side effects of lurbinectedin are: 

We have information about the side effects of:

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 Martin Forster

Supported by

Pharma Mar

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14997

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

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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