A trial looking at crizotinib in people with advanced non small cell lung cancer
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is comparing crizotinib with the chemotherapy drugs pemetrexed and cisplatin or carboplatin in people with non small lung cancer (NSCLC). The trial is for people who have lung cancer with the abnormal ALK gene.
Doctors usually use chemotherapy to treat non small cell lung cancer that has spread to another part of the body. Sadly the cancer can start to grow again.
Cells normally grow in a very orderly way. Chemical messages or signals tell them when to grow and when to stop. But if a gene called ALK is abnormal, the ALK protein can signal to make cancer cells grow abnormally. There is an abnormal ALK gene in many cancers, including lung cancer.
In this trial, doctors are looking at a drug called crizotinib which blocks the ALK protein and stops it sending growth signals to cancer cells. Blocking the ALK gene with crizotinib can stop the lung cancer cells growing. But it only works in cancer with the overactive ALK gene. So it is not suitable for everyone.
The aims of the trial are to
- Find out if crizotinib is better at treating people with non small cell lung cancer with the abnormal ALK gene than pemetrexed combined with cisplatin or carboplatin
- Learn more about the side effects of crizotinib
Who can enter
You may be able to enter this trial if you
- Have non small cell lung cancer that is the non squamous type - your doctor can advise you, that has spread
- Have lung cancer with the abnormal ALK gene
- Have cancer that can be measured on a CT scan
- Are well enough to be up and about for at least half the day (performance status of 0, 1 or 2)
- Have satisfactory blood test results
- Are willing to use reliable contraception during the study and for at least 3 months (for women) or 6 months (for men) after treatment if there is any chance that you or your partner could become pregnant
- Are at least 18 years old
You cannot enter this trial if you
- Have had treatment that reaches your whole body (systemic treatment) for advanced lung cancer in the past
- Have had treatment to try and stop the cancer coming back (adjuvant treatment) in the last year
- Have lung cancer that has spread to your brain unless it has been treated successfully
- Have had major surgery in the last 4 weeks
- Have had radiotherapy in the last 4 weeks unless it was to control symptoms
- Are already on a clinical trial
- Have a medical condition that is a cause for concern
- Have any problems with your heart that are a cause for concern
- Have already had treatment with crizotinib
- Are taking some types of medication including some herbal remedies or drink grapefruit juice – you can ask the trial doctor about this
- Have had any other cancer, apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated at least 3 years ago
- Are HIV positive
- Are pregnant or breastfeeding
This trial will recruit 334 people from around the world.
This 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.
Group 1 have crizotinib capsules every day. You continue to take them for as long as they are helping you.
Group 2 have pemetrexed and either cisplatin or carboplatin through a drip into a vein once every 3 weeks. Each 3 week period is called a cycle of treatment. You have up to 6 cycles.
You fill out questionnaires
- Before you start treatment
- Once a week for the first 3 weeks
- Then every 3 weeks while you are having treatment
- One month after stopping treatment
The questionnaire will ask about side effects and how you’ve been feeling.
This is called a quality of life study.
If you agree to take part in this trial, the researchers will ask for a sample of tissue taken when you had surgery to remove your cancer. This tissue is used to find out if your lung cancer has the ALK gene.
Researchers will also ask for extra blood samples. If you do not want to give these samples, you don’t have to. You can still take part in this study.
You will see the doctors and have some tests before you start treatment. The tests include
- Physical examination
- Some eye tests
- Urine tests
- Blood tests
- CT scan or MRI scan
- Heart trace (ECG)
- Heart ultrasound (echocardiogram) or MUGA scan
- Bone scan
Male patients also have a scan to measure bone thickness (a DXA scan).
During treatment, you see the doctors and have regular blood tests. And you have more ECGs, and CT or MRI scans. Male patients having crizotinib also have another DXA scan in the 7th cycle of treatment.
You see the trial team a month after finishing treatment and have more tests and scans. They then contact you every 8 weeks to see how you are.
The most common side effects of pemetrexed, cisplatin and carboplatin are
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Tiredness (fatigue)
- Feeling or being sick
- A lack of appetite
- Sore mouth
- Rash and itchy skin
The most common side effects of crizotinib are
- Temporary changes in your eye sight such as blurred vision or sensitivity to light
- Feeling or being sick
Location of trialCLOSED
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.
Cancer Research UK
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