A trial looking at erlotinib for advanced non small cell lung cancer (TOPICAL)

Cancer type:

Lung cancer
Non small cell lung cancer

Status:

Results

Phase:

Phase 3

This trial looked at erlotinib (Tarceva) for people with advanced non small cell lung cancer (NSCLC) who were not fit enough to have chemotherapy. This trial was supported by Cancer Research UK.

Erlotinib is a type of biological therapy called a tyrosine kinase inhibitor (TKI for short). Tyrosine kinase is a chemical messenger (an enzyme) that sends messages telling cells to divide and grow. Blocking the effect of tyrosine kinase may help stop cancer cells growing.

The people who took part in this trial either took erlotinib or a dummy tablet (placebo). The aims of this trial were to find out

  • How well erlotinib works for non small cell lung cancer
  • What effect it has on patients' quality of life
  • More about the side effects

Summary of results

The research team found that erlotinib did help stop the cancer growing in some people, but that it didn’t always help people live longer. They found that erlotinib worked better for those who developed a rash during treatment.

This trial recruited 670 people with stage 3b or 4 non small cell lung cancer (NSCLC) who had not had chemotherapy before. Of these 350 had erlotinib and 320 had dummy (placebo) tablets.

When the research team looked at the results in 2010, they found that a year after starting treatment the cancer had stopped growing in

  • 4 out of every 100 people (4%) who took the placebo
  • 9 out of every 100 people (9%) who took erlotinib

The people taking erlotinib had some side effects including a rash, tiredness and diarrhoea. When the research team looked at this in more detail in 2012, they found people who developed a rash in the first 4 weeks of treatment did better than those who didn’t get a rash. They looked at how many people were living a year after treatment, and found that it was

  • 24 out of every 100 people (24%) who had erlotinib and developed a rash
  • 10 out of every 100 people (10%) who had erlotinib but didn’t develop a rash
  • 18 out of every 100 people (18%) who had placebo

The people who developed a rash lived, on average, just over 2 months longer than those who had the placebo. And the people who didn’t develop a rash lived, on average, just over a month less than those who had the placebo.

The research team concluded that having a rash is a sign that the treatment is working, and that people who do not get a rash within in the first 4 weeks of taking erlotinib should stop treatment. But it is important to remember that people shouldn't stop any treatment without discussing it with their own doctor first.

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) but may not have been 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

Professor Siow-Ming Lee

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)
Roche

Other information

This is Cancer Research UK trial number CRUK/03/007.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 339

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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