A study looking at selumetinib for non small cell lung cancer

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

Cancer type:

Lung cancer
Non small cell lung cancer

Status:

Closed

Phase:

Phase 1

This study is looking at a new drug called selumetinib for non small cell lung cancer. This is for non small cell lung cancer (NSCLC) that has spread into surrounding tissues (locally advanced) or has spread to another part of the body (advanced).

Doctors can treat locally advanced and advanced NSCLC with chemotherapy. One combination of chemotherapy that doctors use is gemcitabine or pemetrexed with either cisplatin or carboplatin. This chemotherapy helps but doctors are always looking for ways to improve treatment.

Selumetinib is a type of anticancer therapy called a cancer growth blocker. It stops signals that cancer cells use to divide and grow.

The researchers think that combining selumetinib with gemcitabine or pemetrexed and cisplatin or carboplatin may be better than gemcitabine or pemetrexed and cisplatin or carboplatin alone.

The aims of this trial are to find out

  • How well the combination of selumetinib with gemcitabine or pemetrexed and cisplatin or carboplatin works for NSCLC
  • What the side effects are
  • How safe it is

Who can enter

You may be able to enter this trial if you

  • Have non small cell lung cancer (NSCLC) that is locally advanced (stage 3B) or has spread to another part of your body (stage 4)
  • Have at least 1 area of cancer that has not been treated with radiotherapy, measures at least 10 mm across (if it is a lymph gland 15 mm) and can be seen on a scan
  • Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • Are able to have gemcitabine and cisplatin or carboplatin
  • Have satisfactory blood test results
  • Are willing to use reliable contraception during treatment and for up to 3 months afterwards if there is any chance you or your partner could become pregnant
  • Are at least 18 years old

You cannot enter this trial if you

  • Have already had chemotherapy or a biological therapy to treat your locally advanced or advanced NSCLC – if your chemotherapy was at the time of diagnosis of early NSCLC and was in addition to your main treatment, you may be able to take part if it was completed more than 6 months ago
  • Had surgery or radiotherapy in the past 6 months – you may be able to take part if your radiotherapy was to relieve symptoms, was a month ago and you have no ongoing radiotherapy side effects
  • Have moderate to severe side effects from previous treatment, apart from hair loss
  • Have cancer that has spread to your brain or is causing pressure on your spinal cord (spinal cord compression) – if you have no symptoms, haven’t needed steroids for the past month and your condition is stable you may be able to take part
  • Have high blood pressure that isn’t controlled with medication
  • Have a serious heart problem
  • Have a serious eye problem
  • Have had another cancer in the past 5 years apart from successfully treated non melanoma skin cancer and in situ carcinoma of the cervix
  • Are HIV, hepatitis B or hepatitis C positive
  • Have an infection needing treatment
  • Have a problem with bleeding
  • Have had a kidney transplant
  • Have any other condition that could affect you taking part in this trial
  • Are pregnant or breastfeeding

Trial design

This is a phase 1 study. It will initially recruit 48 people. Everyone taking part will have selumetinib, gemcitabine and cisplatin or carboplatin.

The first few people recruited will have a low dose of selumetinib. If they don’t have any serious side effects, the next few people will have a higher dose of selumetinib. And so on, until they find the best combination dose to give. This is called a dose escalation study.

If this part of the trial goes well, it will recruit another 12 people.

Selumetinib is a capsule. You take them on an empty stomach. You can’t have any food or drink, apart from water, 2 hours before taking them or for 1 hour after taking them. You take them twice a day every day, if you have severe side effects you may need to stop taking them for a short period of time. This is called a drug holiday. Your doctor will talk to you about this if needed.

You have either gemcitabine or pemetrexed and either cisplatin or carboplatin as a drip into a vein. Your doctor will talk to you about how often you have them.

You continue having treatment as long as it is helping you and the side effects aren’t too bad.

If you agree to take part in this study, the researchers will ask for a sample of tissue taken when you originally had a biopsy or surgery to remove your cancer. If you don’t want to give tissue samples for this study, you don’t have to. You can still take part in the trial.

The researchers will ask you for some samples of blood. They will use these to monitor your health during the study and to find out what happens to selumetinib in the body. They will also ask for some blood samples to help understand factors influencing cancer.

Hospital visits

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

  • A physical examination
  • Blood tests
  • Heart scan (MUGA or ECHO)
  • Heart trace (ECG)
  • CT scan or MRI scan
  • Eye tests

During treatment you see the doctor regularly to have a physical examination and blood tests. You have a have a heart scan every 3 months and a CT scan or MRI scan every 6 weeks for 6 months, then every 3 months.

You have another eye test a month after finishing selumetinib.

Side effects

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

You cannot eat Seville oranges or grapefruit, or drink their juices, while taking selumetinib because they can affect the way it works in your body.

The most common side effects of gemcitabine, pemetrexed, cisplatin and carboplatin are

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

We have more information about

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 Emma Dean

Supported by

AstraZeneca
Experimental Cancer Medicine Centre (ECMC)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 10855

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

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

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