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

Dry skin, a rash
Fever
Sore mouth
Diarrhoea
Feeling or being sick (nausea)
Possible swelling of the face, legs and feet while taking selumetinib
Shortness of breath
Tiredness (fatigue)
High blood pressure
Blurred vision
Changes to the way your liver works

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

A drop in blood cells causing an increased risk of infection, bruising or bleeding
Feeling or being sick
Changes to the way your liver works
Shortness of breath
Changes to the way your kidneys work
Hair loss
Nerve damage
Skin rash
Hearing loss

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

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