A trial of a vaccine called Lucanix for advanced non small cell lung cancer

Cancer type:

Lung cancer

Non small cell lung cancer

Status:

Results

Phase:

Phase 3

This trial looked at Lucanix for people who had recently had chemotherapy for non small cell lung cancer that was stage 3 or 4 (advanced cancer).

Advanced non small cell lung cancer (NSCLC) are cancers that might have spread to:

more than 1 lobe of the lung
the lymph nodes
nearby areas in the chest
another part of the body such as the liver or bones

More about this trial

Advanced NSCLC is usually treated with:

After treatment the cancer might get smaller, which doctors call a response. Or it may stay the same size, which doctors call stable disease Open a glossary item .

Researchers are looking at ways to improve treatment and stop the cancer from starting to grow again. In this trial they looked at a cancer vaccine called Lucanix (belagenpumatucel-L). They thought it might help the immune system to recognise and flight lung cancer cells.

The main aims of the trial were to:

see if Lucanix after chemotherapy helped people with NSCLC to live longer
learn more about the side effects

Summary of results

The trial team concluded that overall Lucanix did not help people with NSCLC to live longer. But they did find that if people started Lucanix within 3 months of finishing chemotherapy they lived longer than people who started Lucanix more than 3 months after finishing chemotherapy.

532 people with NSCLC took part in this international phase 3 trial. Everyone had chemotherapy with a platinum drug Open a glossary item before joining the trial.

This was a randomised trial. Everyone was put into 1 of the following treatment groups by computer:

270 people had Lucanix
262 people had a dummy drug (placebo )

Neither they nor their doctor could choose which group they were in. And neither they nor their doctor knew which treatment they were having. This was a double blind trial.

Trial Results Diagram

The trial team looked at how well Lucanix worked. To do this they looked at the amount of time people lived (overall survival). They found that people who had:

Lucanix lived around 20 months
the dummy drug lived around 18 months

The team also looked at the average length of time it took before people’s cancer got worse (progression free survival). They found that this was about 4 months for both groups.

During the study researchers noticed that people who started Lucanix within 3 months of finishing chemotherapy lived longer than people who started Lucanix after 3 months. They found that people who had:

Lucanix within 3 months lived around 21 months
the dummy drug after 3 months lived just over 13 months

Doctors also looked at the possible side effects of treatment. These were:

an infection of the deeper layers of the skin (cellulitis)
cancer spread to the membranes that surround the brain (leptomeningeal carcinomatosis)
skin rash

The trial team concluded that Lucanix does not help people with advanced NSCLC to live longer. But there might be a benefit for people who start Lucanix within 3 months of finishing chemotherapy, and for people who have radiotherapy before Lucanix.

The team also concluded that there weren’t many side effects, so they think this is a safe treatment. They suggest that more clinical trials should be done using Lucanix for people who have finished chemotherapy less than 3 months ago. They also suggest that more studies should be done to look at radiotherapy before treatment with drugs that stimulate the body’s immune system to fight cancer (immunotherapy).

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.