A trial comparing LDK378 to chemotherapy for advanced 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 3

This trial is looking at a drug called LDK378 for non small cell lung cancer that has changes to a protein called ALK (ALK positive NSCLC). The people taking part haven’t had any other treatment for advanced non small cell lung cancer.

If non small cell lung cancer (NSCLC) can’t be removed with surgery, or comes back after surgery, doctors usually treat it with chemotherapy. You may also have biological therapy.

But researchers are looking for new ways to treat advanced NSCLC cancer. 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 in people who haven’t had any other treatment.

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 use a sample of your cancer to test for this)
  • You haven’t had any other type of treatment that reaches your whole body (systemic treatment Open a glossary item) for advanced lung cancer (you may be able to take part if you had treatment before or after surgery to remove your cancer when it was at an earlier stage and it was at least a year before your cancer came back)
  • You have recovered from the side effects of earlier treatment (apart from hair loss), unless they are very mild
  • You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • You have cancer that can be seen and measured on a scan
  • 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 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 any of the chemotherapy drugs used 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 Open a glossary item 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 Open a glossary item (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 nearly 350 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 pemetrexed with either cisplatin or carboplatin. Your doctor will decide which of these 2 drugs is most suitable for you to have alongside pemetrexed. Whichever combination of drugs you have, you have them 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, every 6 weeks 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.

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 Open a glossary item.

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 3 years 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. The trial team will then check how you are every 3 months. You may come to hospital for this, or a member of the team can contact you by phone.

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.

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 most common 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 Open a glossary item)

The most common side effects of cisplatin include

  • Feeling or being sick
  • A drop in blood cells
  • Damage to your kidneys
  • Numbness and tingling in your hands and feet (peripheral neuropathy)
  • Hearing loss or ringing in your ears
  • Loss of appetite
  • Taste changes
  • Hair loss

The most common side effects of carboplatin include

  • Feeling or being sick
  • A drop in blood cells
  • Taste changes
  • Hair loss
  • Weakness
  • A burning sensation where you have the drip
  • Tummy (abdominal) pain
  • Diarrhoea or constipation
  • Mouth sores
  • Infections
  • Numbness and tingling in your hands and feet
  • Kidney damage
  • Hearing loss

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

Clive Mulatero

Supported by

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 11220

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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