A trial looking at pemetrexed for advanced non small cell lung cancer (PARAMOUNT)

Cancer type:

Lung cancer
Non small cell lung cancer

Status:

Results

Phase:

Phase 3

This trial looked at having the chemotherapy drug pemetrexed after combination chemotherapy Open a glossary item for advanced non small cell lung cancer (NSCLC). The people taking part had types of NSCLC that are described as non squamous such as adenocarcinoma.

NSCLC is often diagnosed when it is quite advanced. Doctors may treat advanced NSCLC with chemotherapy, as well as giving treatment to control cancer symptoms (best supportive care Open a glossary item).

Cisplatin is one of the chemotherapy drugs that doctors often use for NSCLC. You usually have it with another chemotherapy drug. This is called combination chemotherapy.

Researchers are trying to improve treatment for advanced NSCLC. In this trial, they looked at a drug called pemetrexed. The people who took part had a combination of pemetrexed and cisplatin. Some people then continued to have pemetrexed alone. Doctors call this maintenance therapy.

The aim of the trial was to see if maintenance pemetrexed and best supportive care were better than a dummy drug (placebo Open a glossary item) and best supportive care after combination chemotherapy for advanced NSCLC.

Summary of results

The trial team found that maintenance treatment with pemetrexed chemotherapy lowered the risk of non small cell lung cancer coming back.

The trial recruited 1,022 people, but for various reasons only 939 people had treatment. The trial was a randomised trial. The people taking part were put into 1 of 2 groups by computer. Neither they nor their doctors could decide which group they were in. And neither of them knew which group they were in either. This is called a double blind trial.

To begin with, everybody had pemetrexed and cisplatin combination chemotherapy. This is called induction treatment. After the induction treatment, they had a scan. If this showed the cancer had not grown, they then had maintenance treatment. A total of 539 people had maintenance treatment.

  • 2 out of 3 (359) had pemetrexed and best supportive care
  • 1 out of 3 (180) had a dummy drug (placebo Open a glossary item) and best supportive care

People continued on the maintenance part of the trial for as long as it was helping them.

The trial team published some results 19 months after the trial started. At that time, the number of people still having treatment was

  • 136 in the group who had pemetrexed and best supportive care
  • 43 in the group who had placebo and best supportive care

The treatment side effects were slightly worse for those people having pemetrexed. They included low red blood cells (anaemia), low white cells (neutropenia) and tiredness (fatigue). But all other side effects were about the same for both groups.

The trial team looked at the average length of time that people were living without any signs of their cancer growing. Researchers call this progression free survival. They found it was

  • Just over 4 months for people who had pemetrexed
  • Just under 3 months for people who had placebo

This showed that maintenance treatment with pemetrexed helped to reduce the risk of the cancer coming back. These results were unlikely to have happened by chance (they were statistically significant Open a glossary item).

In 2013, the trial team published some long term results. By then, only 9 people in the pemetrexed group and 2 people in the placebo group were still having treatment. The researchers looked at the average length of time that people lived after starting treatment (overall survival). They found this was

  • Nearly 14 months for people who had pemetrexed
  • 11 months for people who had the placebo

People having pemetrexed did have more side effects, but the researchers concluded maintenance pemetrexed helps people with non small cell lung cancer that hadn’t got worse during induction treatment.



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.

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 Mayukh Das

Supported by

Eli Lilly and Company Limited

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 1398

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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