A study of nivolumab for small cell lung cancer that has come back after treatment (CA209331)

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 study is for people with small cell lung cancer (SCLC) that has come back after chemotherapy treatment. It is for people who had chemotherapy or chemoradiotherapy including a platinum based drug. Open a glossary item

More about this trial

Chemotherapy is the usual treatment for SCLC. But the cancer can come back. Doctors are looking for new treatments for people when this has happened. 

Nivolumab is type of monoclonal antibody called an immunotherapy. It works by encouraging the body’s own immune system to attack the cancer cells. 

In this study researchers want to compare nivolumab with a chemotherapy drug called topotecan. 

The main aims of this trial are to 

  • find how well nivolumab works for SCLC compared to topotecan
  • learn more about the side effects of both drugs for people with SCLC

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you. 

You may be able to join this study if all of the following apply. You

  • Have small cell lung cancer that has come back or continued to grow after having chemotherapy or chemoradiotherapy that included a platinum based drug
  • Have an area of cancer that they can measure on a CT scan Open a glossary item or an MRI scan Open a glossary item 
  • Must be willing to have a sample of your cancer taken (a biopsy) if there is a not a suitable sample already available
  • Have satisfactory blood test results
  • Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1
  • Are willing to use reliable contraception during treatment and for up to 31 weeks afterwards if there is any possibility you or your partner could become pregnant
  • Are at least 18 years old

You cannot join this study if any of these apply

  • Your cancer has spread to your brain or spine. Unless you have had treatment for it and you haven’t had any symptoms for at least 2 weeks before being randomised in this study. And you can’t be taking steroids or if you are you need to be on a stable dose or a reducing dose of 10 mg or less a day for at least 2 weeks joining the study
  • You have inflammation of the membranes surrounding the brain and spine caused by the cancer (carcinomatous meningitis)
  • You have another type of cancer that needs treatment  
  • You have had another cancer apart from non melanoma skin cancer Open a glossary item and some early cancers Open a glossary item that has been successfully treated at least 2 years ago and you don’t need any treatment for it during the time of this study
  • You have an autoimmune disease Open a glossary item. You may be able to join if you don’t need any systemic treatment or your condition isn’t expected to come back
  • You are taking more than 10mg of steroids a day or any other medication that affects the immune system Open a glossary item within 2 weeks of randomisation apart from inhalers, creams and steroids as replacement for adrenal glands that aren’t working 
  • You have a disease of the tissue around the air sacs of your lung that is causing symptoms or may affect how doctors can treat any possible side effects from the drugs that could affect your lungs
  • You have already had treatment with ipilimumab or another drug that works in a similar way to nivolumab
  • You have already had treatment with topotecan
  • You have had chemotherapy, biological therapy or treatment in a trial in the last 4 weeks
  • You have had major surgery or have not recovered from a traumatic injury within 2 weeks of starting the study treatment
  • You have had radiotherapy in the past 2 weeks
  • You are still having side effects from any anti cancer treatment, apart from hair loss and tiredness (fatigue)
  • You are allergic or sensitive to any of the drugs or their ingredients used in the study
  • You  have HIV, hepatitis B or hepatitis C
  • You have any other medical or mental health condition that the trial team think can affect you taking part 
  • You are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. The researchers need 36 people from the UK and 480 worldwide to take part.

It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.  

  • One group have nivolumab
  • The other group have topotecan

Diagram showing trial design

Nivolumab
You have nivolumab through a drip into a vein once every 2 weeks. It takes about 30 minutes to have. Each 2 week period is called a cycle of treatment

You have nivolumab for as long as it is helping you and the side effects are not too severe. 

Topotecan
You can have topotecan as 

  • a drip into a vein over 30 minutes, every day for 5 days, every 3 weeks 

OR

  • as capsules taken every day for 5 days, every 3 weeks. 

Each 3 week period is a cycle of treatment. 

You have topotecan for as long as it is helping you and the side effects are not too severe. 

Tissue samples
The researchers need a sample of your cancer that was removed when you had surgery or from a biopsy Open a glossary item. You will need to have a biopsy if a sample of your cancer tissue isn’t available. 

They will also ask for another biopsy if your cancer gets worse. You don’t have to agree to this one. You can still take part in the study.

Doctors use these samples to help them learn more about SCLC and how the drugs work. They could help to improve treatment for people with lung cancer in the future.  

Quality of life
The study team will ask you to fill in a questionnaire

  • before you start treatment
  • before the start of each treatment for 6 months
  • every 6 weeks during the rest of treatment
  • a month after treatment
  • 3 months after treatment
  • every 3 months for a year
  • then every 6 months

The questions will ask about how you feel and any symptoms or side effects you might have. This a quality of life study

Hospital visits

You see the doctor to have some tests before taking part. These tests include 

  •  A physical examination
  • Blood tests
  • Heart trace (ECG Open a glossary item)
  • Heart scan (echocardiogram Open a glossary item) or MUGA Open a glossary item scan
  • CT scan
  • MRI scan

You see the doctor at the beginning of each treatment cycle for a physical examination and blood tests. 

You have a CT scan or MRI scan 

  • 6 weeks after your first treatment
  • Every 6 weeks for a year
  • Every 3 months till your cancer starts to grow again

When you finish having treatment in the study you see the doctors at the hospital after

  • 1 month
  • 3 months

After your second visit the doctors will continue to follow you up by telephone or by seeing you in clinic every 3 months. You might have a CT or MRI scan during this time. The doctors will tell you if this is necessary.

Side effects

The most common side effects of nivolumab are 

The most common side effects of topotecan are

  • a drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness 
  • breathlessness
  • tiredness
  • low levels of sodium (salt) in your blood
  • infections

We have more information on 

Your doctor will talk to you about the side effects of the drugs used in this study before you agree to take part. 

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 Timothy Yap

Supported by

Bristol-Myers Squibb

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14084

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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