A trial of nivolumab for advanced non small cell lung cancer (CheckMate 026)

Cancer type:

Lung cancer

Non small cell lung cancer

Status:

Results

Phase:

Phase 3

This trial looked at nivolumab as the first treatment for non small cell lung cancer that has spread to another part of the body.

It was open for people to join between 2014 and 2015, and the research team reported the results in 2017.

More about this trial

Doctors often treat non small cell lung cancer (NCSLC) that has spread to another part of the body with chemotherapy.

Researchers wondered if nivolumab (Opdivo) would work better than chemotherapy for people in this situation.

Nivolumab is a type of immunotherapy. Some cancer cells can hide from the immune system and continue to grow. Nivolumab can help the immune system cells to find the cancer cells, and kill them.

Earlier clinical trials had shown that nivolumab was useful for people who’d already had other treatment for advanced non small cell lung cancer.

This trial was for people who hadn’t had treatment for lung cancer that had spread. Some people taking part had chemotherapy, and some had nivolumab.

The main aim of the trial was to see if nivolumab worked better than chemotherapy as the first treatment for non small cell lung cancer that had spread.

Summary of results

The research team found that nivolumab didn’t work better than chemotherapy as the first treatment for non small cell lung cancer that had spread.

About this trial
This trial was for people who had advanced non small cell lung cancer. They all had cancer that produced a protein called PD-L1. This is called PD-L1 positive cancer.

The 541 people taking part were put into 1 of 2 treatment groups at random. There were:

271 in the nivolumab group
270 in the chemotherapy group

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The people in the chemotherapy group had either carboplatin or cisplatin with either gemcitabine, paclitaxel or pemetrexed. Their doctor decided which combination of drugs was best for them.

Results
The research team looked at how long it was before the cancer started to grow. This is called progression free survival.

They looked at this in 423 people with the PD-L1 protein on at least 5% of their cancer cells. They found it was:

4.2 months for those who had nivolumab
5.9 months for those who had chemotherapy

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They also looked at how long people lived and found it was similar in the two groups:

14.4 months for those who had nivolumab
13.2 months for those who had chemotherapy

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When they looked at how many people were living a year after joining the trial, they found it was just over half in each group:

56% for the nivolumab group
54% for the chemotherapy group

Side effects
About 7 out of 10 people (71%) who had nivolumab, and just over 9 out of 10 people (92%) who had chemotherapy, had some side effects.

Many of the side effects were mild or short lived. But some people had more severe side effects:

nearly 2 out of 10 people (18%) who had nivolumab
about 5 out of 10 people (51%) who had chemotherapy

The most common side effects in the nivolumab group were:

extreme tiredness (fatigue)
diarrhoea
reduced appetite
feeling sick
rash

The most common side effects in the chemotherapy group were fatigue, a drop in blood cells and feeling or being sick.

Conclusion
The research team concluded that nivolumab wasn’t better than chemotherapy as a first treatment for non small cell lung cancer that had spread. But that it did cause fewer side effects.

Sometimes trials show that a treatment isn’t useful for people in a particular situation. But they add to our knowledge and understanding of cancer and how to treat it.

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.