A study looking at ADI PEG 20 to treat small cell lung cancer

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




Phase 2

This study is looking at ADI PEG 20 to treat small cell lung cancer.

Doctors can treat small cell lung cancer with chemotherapy. Unfortunately sometimes the cancer can continue to grow during treatment or come back afterwards. When this happens it is more difficult to treat.

Researchers have found a new way of destroying small cell lung cancer cells in the laboratory, by removing an amino acid Open a glossary item called arginine. Arginine helps with many different jobs in the body, including cell growth Open a glossary item.

Our bodies can make arginine using a protein (a particular enzyme Open a glossary item). This enzyme is often missing in small cell lung cancer cells. So if you remove arginine, they will not be able to replace it. This may stop the cancer cells growing.

The aims of this study are to find out

  • How well ADI PEG 20 works for small cell lung cancer
  • How safe it is

Who can enter

You may be able to enter this trial if

  • You have small cell lung cancer
  • You have had no more than 2 different courses of chemotherapy treatment for small cell lung cancer
  • Your cancer continued to grow during your chemotherapy or came back afterwards
  • Your cancer can be measured on a scan
  • You have cancer cells that don’t have the enzyme needed for the treatment, or only a very tiny amount – the researchers will test for this
  • You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • You have satisfactory blood tests
  • You are willing to use reliable contraception during the study
  • You are at least 18 years old

You cannot enter this trial if

  • You have already had ADI PEG 20
  • You are allergic to any drugs that have been treated in the same way as this study drug (they have been pegylated Open a glossary item) - you can check this with your doctor
  • Your cancer has spread to your brain or spinal cord – if you have had treatment for this and you have no symptoms you may be able to take part
  • You have had radiotherapy or chemotherapy in the past 3 weeks (6 weeks for chemotherapy drugs called nitrosoureas Open a glossary item)
  • You have had an experimental drug as part of a clinical trial in the past 3 weeks
  • You have fits (seizures) that aren’t controlled by medication
  • You are known to be HIV positive
  • You have a serious illness, infection or medical condition that could affect you taking part in this trial
  • You are pregnant or breastfeeding

Trial design

This is a phase 2 study. It will recruit up to 45 people. Everyone will have ADI PEG 20.

You have ADI PEG 20 as an injection into a muscle in your arm or leg every week. You continue having ADI PEG 20 as long as it is helping you.

If you agree to take part in this study, the researchers will ask for some samples of tissue of your cancer (biopsy Open a glossary item). They will do this to learn more about small cell lung cancer and to look for the enzyme the cancer needs to have. If you don’t want to give tissue samples for this study, you don’t have to. You can still take part in the trial.

Hospital visits

You see the doctor and have some tests before taking part in this study. These test include

  • A physical examination
  • Blood tests
  • CT scan

During treatment you see the doctor every 2 weeks for a physical examination and blood tests. You have a CT scan every 4 to 8 weeks.

After treatment your doctor will talk to you about how often they want to see you.

Side effects

Side effects of ADI PEG 20 include

  • Redness and tenderness where you had the injection
  • Risk of pain and inflammation in the big toe and foot (gout) – you will have blood tests, and treatment to prevent this if needed
  • A drop in blood pressure
  • Small fits where you lose awareness for a few moments (petit mal seizures) – these do not cause long term effects, and the team will be able to offer you suitable treatment

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

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 Peter Szlosarek

Supported by

Barts Health NHS Trust
Ludwig Institute for Cancer Research
Polaris Pharma

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 10706

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

A picture of Cara

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

Last reviewed:

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