A trial comparing docetaxel and ramucirumab to docetaxel alone for non small cell lung cancer that has come back after treatment

Cancer type:

Lung cancer

Non small cell lung cancer

Status:

Results

Phase:

Phase 3

This trial compared a drug called ramucirumab (pronounced ram-oo-seer-oo-mab) and docetaxel chemotherapy to docetaxel alone to treat non small cell lung cancer. It was for people whose cancer had spread to another part the body and had come back after treatment.

Doctors can treat non small cell lung cancer that has spread with chemotherapy such as docetaxel. But sometimes the cancer starts to grow again. When this happens it is often more difficult to treat.

Ramucirumab is a type of biological therapy called a monoclonal antibody. Monoclonal antibodies can seek out cancer cells by looking for particular proteins on the cell surface. Blocking them may stop the cancer growing.

Doctors want to find out if ramucirumab and docetaxel is better than docetaxel alone to treat non small cell lung cancer that had spread and had come back after treatment.

The aims of this trial were to find out

If ramucirumab and docetaxel are better at treating non small cell lung cancer that had spread than docetaxel alone
About the side effects

Summary of results

The trial team found that ramucirumab with docetaxel helped people to live longer when they had non small cell lung cancer that had spread.

This was an international phase 3 trial. This randomised trial recruited 1,253 people. They were put into 1 of 2 treatment groups. Neither they nor their doctor chose which group they were in

628 people had ramucirumab and docetaxel
625 people had docetaxel and a dummy drug (placebo )

When the researchers looked at the average time people were free of their cancer they found that it was

4½ months for those who had ramucirumab and docetaxel
3 months for those who had docetaxel and the dummy drug

Trial diagram

The average overall time people lived was

10½ months for those who had ramucirumab and docetaxel
9 months for those who had docetaxel and the dummy drug

Trial diagram

The most common side effects in both groups were

A drop in blood cells causing an increased risk of infection, bruising and bleeding
Tiredness (fatigue)
Loss of appetite
Feeling or being sick
Hair loss
Sore mouth
Shortness of breath
Cough

The trial team concluded that people with non small cell lung cancer that had spread lived longer when treated with ramucirumab and docetaxel than with docetaxel alone.

We have based this summary on information from the team who ran the trial. 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. We have not analysed the data ourselves.