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A trial looking at nivolumab for non small cell lung cancer

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

This trial is looking at a new drug called nivolumab to treat non small cell lung cancer (NSCLC) that has spread to surrounding tissues or to another part of the body (advanced cancer).

Doctors usually treat advanced NSCLC with cisplatin or carboplatin and another chemotherapy drug. Unfortunately sometimes the cancer continues to grow or comes back after treatment. If this happens they may then use the chemotherapy drug docetaxel or a biological therapy drug such as erlotinib.

Nivolumab is a type of biological therapy called a monoclonal antibody. It seeks out cancer cells by looking for particular proteins.

We know from research that nivolumab may help people with NSCLC. The researchers want to compare nivolumab with docetaxel.

The aims of this trial are to find out

  • How well nivolumab works for people with NSCLC
  • What the side effects of nivolumab are
  • How safe it is

Recruitment

Start 06/02/2013
End 08/11/2013

Phase

Phase 3

Who can enter

You may be able to enter this trial if

  • You have non small cell lung cancer (NSCLC) that has spread into surrounding tissues or to another part of the body (stage 3B) or has come back after having radiotherapy or surgery to remove your cancer (stage 4)
  • You have squamous type NSCLC
  • Your cancer continued to grow or came back after having a platinum chemotherapy drug, such as carboplatin or cisplatin, with another anti cancer drug  
  • Your cancer can be measured on a scan
  • You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • You have had a small sample of cancer tissue (a biopsy) removed from your lung or where your cancer has spread to, or if needed you would be willing to have a biopsy
  • You have satisfactory blood test results
  • You are willing to use reliable contraception during treatment and for a period of time afterwards if there is any chance you or your partner could become pregnant – your doctor will talk to you about this
  • You are at least 18 years old

You cannot enter this trial if you

  • Have cancer that has spread to your spine or brain – if the cancer spread has been successfully treated and you have had no symptoms for at least 2 weeks you may be able to take part
  • Have cancer cells in the thin layers of tissue that protect the brain and spine (carcinomatous meningitis)
  • Have a disease where your body mistakenly identifies something that is natural to it as foreign (autoimmune disease) for example, vitiligo or rheumatoid arthritis
  • Are taking more than 10 mg of steroids a day or any other medication that dampens down the immune system in the past 2 weeks – if you are using a steroid inhaler or putting a steroid cream on to your skin (topical) you may be able to take part
  • Have already had the chemotherapy drug docetaxel
  • Had a cancer growth blocker drug, such as gefitinib, after having chemotherapy –  if you were having erlotinib after chemotherapy and your cancer started to grow again you may be able to take part
  • Are still having side effects from any anti cancer treatment, apart from hair loss and tiredness (fatigue)
  • Have had nivolumab before or a similar drug – your doctor can confirm this
  • Have another cancer that needs treatment
  • Have had another cancer apart from non melanoma skin cancer, in situ cancer of the bladder, stomach, breast, cervix, or melanoma, or any other cancer that was successfully treated and there hasn’t been any sign of it for at least 2 years and you will not need treatment for it during the trial
  • Have a disease of the lung that affects the tissue and the space around the air sacs – your doctor can explain
  • Have had major surgery or a significant injury in the past 2 weeks
  • Are known to be HIV, hepatitis B or hepatitis C positive
  • Are taking medication that affects the CYP3A4 enzyme
  • Have had an experimental drug as part of another clinical trial in past month
  • Are allergic to the drugs used in this trial, their ingredients or similar drugs
  • Are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. It will recruit 260 people from different countries around the world. It is a randomised trial. The people taking part are put into 1 of 2 treatment groups by a computer.

You will have either nivolumab or docetaxel.

Nivolumab for NSCLC trial diagram

In group 1 you have nivolumab every 2 weeks.

In group 2 you have docetaxel every 3 weeks.

Nivolumab and docetaxel are liquids. You have them as an injection into a vein. Each takes an hour. You can continue to have treatment as long as it is helping you and the side effects aren’t too bad.

To take part in this trial the researchers need a piece of cancer tissue taken when you had surgery or a biopsy. If this isn’t available then you’ll need to have another biopsy taken. You must agree to this to take part in this trial.

If you have nivolumab the researchers will take blood samples before you have it. They will use these samples to find out what happens to nivolumab in the body and how it is absorbed.

The trial team will take other blood samples from everyone in the trial. They will use these samples to look for substances (biomarkers) in the body that may show how your cancer is responding to treatment.

The trial team will ask you to fill out a questionnaire before you start treatment and at regular times during treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

You see the doctor to have some tests before taking part in this trial. These tests may include

During treatment you see the doctor regularly for a physical examination and blood tests. You have a CT scan or MRI scan every 6 weeks.

After treatment you see the doctor every 3 months.

Side effects

Nivolumab is a new drug and there may be side effects we don’t know about. The most common side effects reported include

The most common side effects of docetaxel are

  • A drop in blood cells causing an increased risk of infection, bruising or bleeding
  • Shortness of breath
  • Cough
  • Infection
  • Hair loss
  • Swelling of the legs and feet caused by fluid retention
  • Feeling or being sick (nausea)
  • Numbness and tingling in the feet and hands
  • Diarrhoea
  • Feeling weak
  • Tiredness (fatigue)
  • Sore mouth

Your doctor will talk to you about the side effects before you agree to take part in this trial.

We have more information on docetaxel in our cancer drugs section.

Location of trial

CLOSED

For more information

Please note: we cannot help you to join a specific trial. Unless we state otherwise in this trial summary, you need to print this page and take it to your own doctor to discuss.

Find out how to join a trial or contact our cancer information nurses for other questions about cancer by phone (0808 800 4040), by email, or at

The Information Nurses
Cancer Research UK
Angel Building
407 St John Street
London
EC1V 4AD

Chief Investigator

Professor Christian Ottensmeier

We have more information about the work of Prof Christian Ottensmeier.

Supported by

Bristol-Myers Squibb
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)
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Updated: 14 November 2013