A trial of afatinib for people with non small cell lung cancer who cannot have chemotherapy (TIMELY)
Cancer type:
Status:
Phase:
This trial looked at afatinib for non small lung cancer (NSCLC) for people who cannot have chemotherapy.
It was open to people with NSCLC that had, or was suspected to have, a change (
) in the EFGR .
The trial was open for people to join between 2013 and 2015. The team published the results in 2024.
Cancer Research UK supported this trial.
More about this trial
Doctors can treat non small cell lung cancer with chemotherapy. But some people are not well enough to have chemotherapy. Or they choose not to have this type of treatment. In this trial, researchers looked at a drug called afatinib to see if it helped people in this situation. And who had a confirmed, or suspected, change in a protein called epidermal growth factor receptor (EGFR).
Afatinib is a type of called a growth blocker. It works by targeting the EGFR protein.
Drugs that target EGFR are more likely to work if the cancer cells have a change () to a gene called EGFR.
Lung cancer is often linked to smoking. People with lung cancer who have never smoked or were light smokers in the past, are more likely to have cancer with an EGFR gene change.
The aim of the trial was to see if afatinib helps to stop the growth of non small cell lung cancer in people who have, or are suspected to have, an EGFR gene change.
Summary of results
This trial showed that afatinib can be a treatment option for non small cell lung cancer (NSCLC) with a change in the EFGR gene.
. All of the 39 people who took part had afatinib. When the trial began, 21 people had a tissue sample () that confirmed their cancer had a change in the EGFR gene.
Of the 18 people suspected to have the EGFR gene change:
- 7 were former smokers
- 10 never smoked
- for 1 person it was not known whether they smoked or not
How well treatment worked
When the researchers published their results the follow up was just over 8 years (98 months).
The team looked at how long it took for the cancer to get worse. They found that 11 of the 39 people’s cancers had not got worse by 18 months.
For 5 people, their cancer had not got worse after 3 years. All 5 of these people had a change in the EGFR gene. Since then, for 3 of them their cancer had got worse, or they had died when the paper was written.
Of the 39 people in the trial, 9 were alive after 3 years, 8 had an EGFR gene change and for 1 person it was suspected they did. At the time of writing these results 4 were still alive.
The team looked at which point after treatment that half of the 39 people’s cancer had got worse. They found it was just under 8 months (7.9 months).
They also looked at which point after treatment that half of the 39 people were living. They found it was 15.5 months.
The team found that afatinib worked best for cancers with particular EFGR gene changes.
Circulating tumour DNA
Tiny pieces of the DNA of tumours can break off and circulate in the bloodstream. This is called .
The team looked at using ctDNA from the people’s blood samples to help confirm an EFGR gene change. They wanted to see if this helped when a tissue sample (biopsy) is unable to detect a change. Or when there is no tissue available to test. They found that ctDNA can be used to confirm an EGFR change which can add to the routine tissue testing for EGFR changes. They also found that ctDNA could help doctors:
- find out when treatment is working
- find another treatment that might work when the initial treatment has stopped working
- predict how well treatment might work
Side effects
Just under a third of the people (31%) stopped treatment due to side effects. 12 people (54%) had to have a reduced dose of afatinib due to side effects. Two people also took a break from treatment due to side effects. They restarted treatment after a month’s break.
Nearly 9 out of every 10 people (87%) had a severe side effect. The most common of these were:
- diarrhoea
- being sick
- high blood pressure
Other common side effects included:
- feeling sick
- tiredness
- infections
- not having enough water in the body
- eye problems
- sore mouth
- hair loss
- dry skin
- skin rash
We have more information about afatinib.
Conclusion
The team concluded that:
- afatinib is a treatment option to be considered for people with NSCLC who have a change in the EFGR gene detected through tissue or blood and who are not able to have chemotherapy
- for some of these people, a long term benefit was shown
- testing for ctDNA in the blood improved detection of changes in the EGFR which may help doctors work out how well treatment will work
More detailed information
There is more information about this research in the reference below.
Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.
Long term efficacy of first-line afatinib and the clinical utility of ctDNA monitoring in patients with suspected or confirmed EGFR mutant non-small cell lung cancer who were unsuitable for chemotherapy
S Popat and others
British Journal of Cancer, 2024, Open access.
We have based this summary on the information in the article above. This has been reviewed by independent specialists () and published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.
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.
Chief Investigator
Professor Sanjay Popat
Supported by
Boehringer Ingelheim
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University College London (UCL)
Other information
This is Cancer Research UK trial number CRUKE/10/040.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
