A trial of LDK378 for people with advanced non small cell lung cancer who have already had chemotherapy and crizotinib

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 3

This trial is comparing a drug called LDK378 with chemotherapy for non small cell lung cancer that has changes to a protein called ALK (ALK positive NSCLC). It is for people who have already had a drug called crizotinib and chemotherapy that included a platinum drug.

If non small cell lung cancer (NSCLC) can’t be removed with surgery, doctors usually treat it with chemotherapy. You may also have a biological therapy such as crizotinib.

But NSCLC cancer can continue to grow despite having these treatments. If this happens, you may have more chemotherapy, but researchers are looking for other treatments to help people in this situation. In this trial, they are looking at a drug called LDK378.

If there are changes to a protein called anaplastic lymphoma kinase (ALK), it can send signals to cancer cells telling them to grow. LDK378 blocks the ALK protein and stops it sending growth signals to cancer cells, which may stop them growing.

The aim of the trial is to see if LDK378 works better than chemotherapy for ALK positive non small cell lung cancer that has got worse despite having crizotinib and platinum chemotherapy.

Who can enter

You may be able to enter this trial if

  • You have non small cell lung cancer that is stage 3B or stage 4
  • Your cancer is ALK positive (the trial team will get a sample of your cancer to test for this)
  • You have already had crizotinib and chemotherapy that included a platinum drug, but your cancer has got worse despite having these treatments
  • You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • Your cancer can be seen and measured on a scan
  • You have recovered from the side effects of earlier treatment (apart from hair loss), unless they are very mild
  • You have satisfactory blood test results
  • You are at least 18 years old
  • You are willing to use reliable contraception during the trial and for 3 months afterwards if there is any chance you or partner could become pregnant – if you are male and sexually active, you must use condoms during the trial and for 3 months afterwards even if there isn’t any chance that your partner could become pregnant

You cannot enter this trial if you

  • Have cancer that has spread to your brain unless this is stable and if you take steroids, the dose has not increased in the last 2 weeks
  • Have cancer that has spread to the tissues covering your brain (carcinomatous meningitis)
  • Have had more than  2 other types of chemotherapy for advanced non small cell lung cancer
  • Have already had a drug that targets the ALK protein (apart from crizotinib)
  • Have had any other type of treatment that reaches your whole body (systemic treatment) for advanced NSCLC
  • Have had radiotherapy (apart from radiotherapy for symptoms) in the last 2 weeks, or haven’t recovered from the side effects of earlier radiotherapy
  • Have had surgery to remove cancer spread to your brain in the last 2 weeks, or other major surgery in the last 4 weeks
  • Are known to be very sensitive to anything in LDK378 or to the chemotherapy drug that your doctor chooses to use in this trial
  • Have had any other cancer in the last 3 years, unless it was a very early stage and was completely removed with surgery
  • Have had a heart attack in the last 6 months or have certain other heart problems – the trial team can advise you about this
  • Have high blood pressure that can’t be controlled with medication
  • Have a problem with your digestive system that could affect how you absorb the trial drug
  • Take other medication that could affect body substances called cytochrome P (CYP) enzymes – the trial team can advise you about this
  • Take drugs to thin your blood such as warfarin, drugs that can affect your heart rhythm, steroids (unless it is a low dose), or certain types of drugs to prevent fits – the trial team can advise you about this and it is important not to stop taking any medication without speaking to your doctor first
  • Have any other medical condition or mental illness that the trial team think could affect you taking part
  • Are pregnant or breastfeeding

Trial design

This phase 3 trial will recruit 236 people. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

People in one group take LDK378 capsules every day. People in the other group have chemotherapy.

trial diagram

If you are in the LDK378 group, the trial team will tell you exactly how and when to take the capsules.

If you are in the chemotherapy group, you have either pemetrexed or docetaxel. Your doctor will decide which drug is most suitable for you. Whichever drug you have, you have it through a drip into a vein once every 3 weeks.

As long as you don’t have bad side effects, you can carry on having treatment for as long as it helps you. If you are in the chemotherapy group and your cancer is getting worse, you may be able to start having LDK378 instead.

The trial team will ask you to fill out some questionnaires before you start treatment, a number of times during treatment and after you finish treatment. The questionnaires will ask about side effects and how you’ve been feeling.  This is called a quality of life study.

If you stop treatment for any reason other than your cancer getting worse, you will have a CT or MRI scan every few weeks until your cancer does start to get worse.

Hospital visits

You see the trial team and have some tests before you start treatment. The tests include

You may also have a bone scan.

The trial team need to find out if your lung cancer is ALK positive. They will test a sample of your cancer that was removed in the past when you had surgery or a biopsy. If there isn’t a sample available, you will need to have a biopsy.

You see the trial team regularly during treatment. If you are having chemotherapy, you go to hospital at least once every 3 weeks. If you are having LDK378, you go to hospital every 2 weeks for the first month and then every 4 weeks.

At each visit you have a physical examination, a blood test and a heart trace. You have a CT or MRI scan every 6 weeks for the first 18 months of treatment and then every 9 weeks after that.

When you finish treatment, you see the trial team again. You have a physical examination and more blood tests. After that, the trial team will check how you are every 3 months. You may come to hospital for this, or a member of the team may contact you by phone.

Side effects

As LDK378 is a new drug, there may be side effects we don’t know about yet. The most common known side effects include

The side effects of pemetrexed include

  • A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • Fatigue
  • High temperature (fever)
  • Blood clots
  • Feeling or being sick
  • Constipation
  • Loss of appetite
  • Shortness of breath
  • Chest pain
  • Sore mouth
  • Lack of fluid in your body (dehydration)

The side effects of docetaxel  include

  • A drop in blood cells
  • Feeling or being sick
  • Diarrhoea
  • Fluid retention
  • Weakness
  • Sore mouth
  • Skin changes
  • Infections

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 Samreen Ahmed

Supported by

Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Novartis

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 11151

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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