A trial to see if the protein ERCC1 affects how non small cell lung cancer responds to different types of chemotherapy

Cancer type:

Lung cancer
Non small cell lung cancer

Status:

Results

Phase:

Phase 3

This trial looked at whether chemotherapy without platinum drugs worked better than platinum based chemotherapy for people with lung cancer. It was for people with a non small cell lung cancer (NSCLC) that had spread (advanced cancer).

Cancer Research UK supported this trial.

More about this trial

Surgery or radiotherapy are both treatments for NSCLC. But if your cancer is advanced when it is diagnosed you will probably have chemotherapy.

Chemotherapy for NSCLC usually includes a platinum drug such as cisplatin. But this type of chemotherapy helps some people more than others.

Platinum drugs damage the genetic material inside cells (the DNA). ERCC1 is a protein that helps to repair any damage to DNA.

Cancer cells may use ERCC1 to repair the damage caused by platinum drugs, which then allows the cancer to carry on growing. So it is possible that people with high levels of ERCC1 would do better having a different type of chemotherapy.

In this trial, some people had chemotherapy that included a platinum drug. Some had another type of chemotherapy. The researchers looked at everybody’s levels of ERCC1. They compared all the results from the 2 groups at the end of the trial.

The aims of the trial were to see:

  • if chemotherapy without a platinum drug was better for people with advanced non small cell lung cancer and high levels of ERCC1
  • if chemotherapy including a platinum drug worked as well, or better, for people who had low levels of ERCC1 

Summary of results

The team found that for squamous cell Open a glossary item non small cell lung cancer chemotherapy including a platinum drug worked better than chemotherapy that didn’t. But there was little difference for people who have a non squamous cell lung cancer.  

The level of ERCC1 made no difference to how well people did with any type of treatment.

This was a phase 3 trial. 648 people took part.

Researchers put people into 2 groups depending on whether their cancer was squamous cell or non squamous cell.

They also tested a sample of the cancer from everyone for the ERCC1 protein.

People who had squamous cell NSCLC
177 people who had squamous cell NSCLC were put into 1 of 2 groups by a computer (randomised). 

Results Diagram

The researchers looked at how well treatment worked (a response).  They found the following numbers of people, whose cancer had the ERCC1 protein, responded to treatment:

  • 50 out of every 100 people (50%) who had cisplatin and gemcitabine
  • 27 out of every 100 people (27.4%) who had paclitaxel and gemcitabine

For those whose cancer didn’t have the protein this was:

  • 57 out of every 100 people (57.1%) who had cisplatin and gemcitabine
  • 23 out of every 100 people (23.5%) who had paclitaxel and gemcitabine

The team also looked at the average length of time that people lived after treatment. It was:

  • just over 10½ months for those who had cisplatin and gemcitabine
  • just over 7½ months for those who had paclitaxel and gemcitabine

results diagram

These results showed that cisplatin was much better than paclitaxel for people who had squamous cell NSCLC. So the data monitoring committee Open a glossary item that supervised the trial:

  • advised the researchers to stop recruitment to this part of the trial
  • suggested those who were having paclitaxel should change to cisplatin.

People who had non squamous cell NSCLC
471 people who had non squamous cell NSCLC were randomly put into 1 of 2 treatment groups:

results diagram

The researchers looked at how many people responded to treatment. For those whose cancer had the ERCC1 protein this was:

  • 48 out of every 100 people (48.4%) who had cisplatin and pemetrexed
  • 33 out of every 100 people (33%) who had paclitaxel and pemetrexed

For those whose cancer didn’t have the protein this was:

  • 32 out of every 100 people (32.9%) who had cisplatin and pemetrexed
  • 39 out of every 100 people (39%) who had paclitaxel and pemetrexed

The average length of time people lived was:

  • just over 9½ months for those who had cisplatin and pemetrexed
  • 8 months for those who had paclitaxel and pemetrexed

results diagram

Using ERCC1 protein results as a biomarker
The trial team also looked at the ERCC1 protein as a biomarker Open a glossary item to try and predict how well the cancer responded and how long people lived after treatment. No difference was found between people whose cancer had the protein and those who didn’t.

The trial team concluded platinum based chemotherapy was best for advanced squamous cell NSCLC. The ERCC1 protein couldn’t be used to predict how well the cancer would respond to treatment or how long people might live after treatment.

We have based this summary on information from the research team. 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 who did the research. 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

Prof Siow Ming Lee

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Eli Lilly and Company Limited
NIHR Clinical Research Network: Cancer
UCL Cancer Trials Centre

Other information

This is Cancer Research UK trial number CRUKE/08/021.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

2414

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

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

Last reviewed:

Rate this page:

No votes yet
Thank you!
We've recently made some changes to the site, tell us what you think