A trial of talactoferrin for advanced non small cell lung cancer (FORTIS-M)

Cancer type:

Lung cancer
Non small cell lung cancer

Status:

Results

Phase:

Phase 3

This trial looked at a drug called talactoferrin for non small cell lung cancer that has got worse despite treatment.

Doctors can treat non small cell lung cancer with surgery, radiotherapy, chemotherapy or biological therapy. But this type of cancer often comes back after treatment and researchers are looking for new treatments to help people in this situation.

In this trial, they looked at a drug called talactoferrin. Talactoferrin is made in the laboratory, but is similar to a body substance called lactoferrin. Lactoferrin is normally found in white blood cells Open a glossary item and in body liquids such as breast milk, saliva and tears. Lactoferrin can help the body fight infections and reduce swelling (inflammation Open a glossary item). It may also help the immune system Open a glossary item to kill lung cancer cells.

The aim of this trial was to see if having talactoferrin helped people with non small cell lung cancer that had got worse despite already having had 2 other types of treatment.

Summary of results

The researchers found that talactoferrin was not a useful treatment for people with advanced non small cell lung cancer that had got worse despite treatment.

This trial recruited 742 people with non small cell lung cancer. They had all had 2 or more different types of treatment for their lung cancer in the past.

The people taking part were put into 1 of 2 groups at random. For every 3 people taking part, 2 had talactoferrin liquid to swallow and 1 had dummy liquid (a placebo Open a glossary item) to swallow. So

  • 497 had talactoferrin
  • 245 had the placebo

The research team looked at

  • How well the treatment worked
  • How many people had signs that their cancer had continued to grow
  • The number of people alive a year after treatment

They found that there was no difference between the 2 groups in any of these.

They also found that talactoferrin didn’t cause very many side effects, and they were often mild.

The research team concluded that talactoferrin was not a useful treatment for people with advanced non small cell lung cancer that had got worse.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.

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 Yvonne Summers

Supported by

Agennix Incorporated
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer

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Last review date

CRUK internal database number:

Oracle 5648

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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