A trial of ceritinib for people with advanced non small cell lung cancer who have already had chemotherapy and crizotinib (ASCEND-5)

Cancer type:

Lung cancer
Non small cell lung cancer

Status:

Results

Phase:

Phase 3

This trial compared ceritinib with chemotherapy for people with non small cell lung cancer who had already had chemotherapy and crizotinib. It was for people with ALK gene changes (ALK positive cancer).

This trial was open for people to join between 2013 and 2015, and the team published the results in 2017.

More about this trial

Doctors often treat non small cell lung cancer (NSCLC) that has spread with chemotherapy or a targeted cancer treatment. When this trial was done, they often used a platinum chemotherapy drug  Open a glossary itemand crizotinib.

Researchers wanted to know if ceritinib (LDK378) would be useful for people who’ve already had these treatments, but whose cancer has continued to grow.

Ceritinib is a type of targeted treatment called a cancer growth blocker. It helps stop the signals that cancer cells use to divide and grow. It works better for people whose cancer cells have changes in the anaplastic lymphoma kinase (ALK) gene. This is called ALK positive cancer.

The main aim of the trial was to see if ceritinib works better than standard chemotherapy for ALK positive non small cell lung cancer. It was for people whose cancer had continued to grow after platinum chemotherapy and crizotinib.

Summary of results

The research team found that ceritinib worked better than chemotherapy for people whose lung cancer had continued to grow after chemotherapy and crizotinib.

Trial design
The people taking part in this trial had already had platinum chemotherapy and crizotinib treatment, but their non small cell lung cancer had continued to grow.

A total of 231 people joined the trial. They were put into 1 of 2 treatment groups at random:

  • 115 in the ceritinib group
  • 116 in the standard chemotherapy group

 

The people in the standard chemotherapy group had either pemetrexed or docetaxel. Their doctors decided which treatment was best for them.

Results
The research team looked at how long it was before the cancer started to grow again. They found it was:

  • 5.4 months for those who had ceritinib
  • 1.6 months for those who had standard chemotherapy

 Within the standard chemotherapy group it was:

  • 2.9 months for those who had pemetrexed
  • 1.5 months for those who had docetaxel

When they looked at how long people lived for, they found it was similar in the two groups. But it was too early to analyse the information properly as only a small number of people had died. So they couldn’t draw any firm conclusions. 

Quality of life
The research team asked people taking part to fill out quality of life questionnaires before, during and after treatment. They were asked about how they were feeling and about any side effects they’d had.

The results showed that people’s quality of life was similar in both groups for many things. But that it was slightly better in some areas for people who had ceritinib.

Side effects
More than 9 out of 10 people (96%) who had ceritinib and nearly 8 out of 10 people (79%) who had chemotherapy had at least one side effect. But many were mild or didn’t last long.

About 1 out of 10 people (11%) in both groups had a side effect that was more serious. 

The most common more serious side effects for people who had ceritinib were changes in liver proteins (enzymes). But this didn’t cause long term liver problems or liver damage.

The most common serious side effect for those who had chemotherapy was a drop in white blood cells.

Conclusion
The trial team concluded that ceritinib was better than chemotherapy for ALK positive non small cell lung cancer that had come back after chemotherapy and crizotinib. 

Where this information comes from    
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

Dr Samreen Ahmed

Supported by

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

Freephone 0808 800 4040

Last review date

CRUK internal database number:

11151

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

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