A study looking at dabrafenib and trametinib for non small cell lung cancer

Cancer type:

Lung cancer

Non small cell lung cancer

Secondary cancers

Status:

Results

Phase:

Phase 2

This study looked at 2 drugs called dabrafenib and trametinib for non small cell lung cancer. It was for people whose cancer had spread elsewhere in the body. This is advanced non small cell lung cancer.

The study was open for people to join between 2012 and 2015. The team published some results in 2017. They published the final results in 2022.

More about this trial

Chemotherapy is a usual treatment for non small cell lung cancer (NSCLC). This can work for a while but sometimes the cancer begins to grow again.

A small number of people with NSCLC have changes in the gene Open a glossary item called BRAF. This gene makes proteins that affect how cancer cells divide and grow.

Doctors are looking for treatments for people with the BRAF gene change in their lung cancer cells. In this trial, they looked at dabrafenib and trametinib. They are both types of targeted drugs called cancer growth blockers. They work in slightly different ways to stop signals that cancer cells use to divide and grow.

We know from research that trametinib and dabrafenib may work better than dabrafenib only. The researchers think that this may be the case for people with NSCLC.

The aims of this study were to find out:

how well dabrafenib works on its own
how well trametinib and dabrafenib work together
more about the side effects

Summary of results

The main findings of this study were:

dabrafenib worked for people who had a BRAF V600E gene mutation in their lung cancer cells
dabrafenib worked well alongside trametinib
the side effects were manageable

About this trial
This phase 2 trial took place worldwide.

There were 3 groups in this trial.

84 people had dabrafenib (group A)
57 people who’d already had treatment for advanced NSCLC had dabrafenib and trametinib (group B)
36 people who hadn’t had treatment for advanced NSCLC had dabrafenib and trametinib (group C)

9584-randomisation.png

Everyone had treatment for as long as it was working, and the side effects weren’t too bad.

Results for group A
84 people joined group A. Of those:

78 had already had treatment for advanced cancer
6 hadn’t had any treatment for advanced cancer

Researchers followed everyone for about 10 months. They looked at how well treatment worked. They found:

in 27 out of 78 people (34%) who’d had treatment, the cancer went away a little bit
in 4 out of 6 people (66%) who hadn’t had treatment, the cancer went away a little bit

The team looked at the length of time before the cancer started to grow again. This was about 5.4 months.

Results for group B
Group B was for people who’d already had treatment for advanced NSCLC. It included 57 people.

Researchers looked at how well treatment worked. They followed everyone up for about 17 months. They had the results for 53 people. They found in:

3 people (5%) the cancer went away completely
36 people (63%) the cancer got a bit better
7 people (12%) the cancer stayed the same
7 people (12%) the cancer got worse

They also looked at the length of time before the cancer started to grow again. This was about 10.2 months.

Results for group C
Group C was for people who hadn’t had treatment for advanced NSCLC. It included 36 people. The researchers followed everyone up for about 16 months. They looked at how well treatment worked. They had the results for 32 people. They found in:

2 people (6%) the cancer went away completely
21 people (58%) the cancer went away a little bit
4 people (11%) the cancer stayed the same
5 people (14%) the cancer got worse

They also looked at the length of time before the cancer started to grow again. This was about 10.8 months.

Side effects
For people who had dabrafenib only, the most common side effects were:

an increased risk of developing a non melanoma skin cancer
lack of energy

Some of the more serious side effects of dabrafenib and trametinib included:

high temperatures (fever)
liver changes
high blood pressure
an increased risk of infection (neutropenia )
a drop in the number of red blood cells (anaemia )
low levels of salt in the blood

Conclusion
The trial team concluded that:

dabrafenib worked for people with a BRAF gene change in their lung cancer cells
dabrafenib and trametinib worked for people with a BRAF gene change in their lung cancer cells
the side effects of the drugs were manageable

In this small trial, dabrafenib and trametinib worked for people with NSCLC who had the BRAF V600E gene change. And the side effects were manageable. The team say more research needs to be done to confirm these findings.

Where these results come 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.