A trial looking at olaparib for non small cell lung cancer (PIN)
This trial is looking at olaparib for non small cell lung cancer (NSCLC). This is for NSCLC that has spread to another part of the body (advanced). This trial is supported by Cancer Research UK.
Doctors can treat advanced NSCLC with chemotherapy. This helps but they are always looking for ways to improve treatment. In this trial researchers are looking at a drug called olaparib.
Olaparib is a type of biological therapy called a PARP inhibitor. It blocks an enzyme that cancer cells need to repair themselves and grow. The researchers think that giving olaparib after chemotherapy may delay or prevent NSCLC from starting to grow again. This is called maintenance therapy.
In this trial some people will have olaparib after chemotherapy and some will have a dummy drug (placebo).
The aims of this trial are to find out
- If olaparib can help stop or delay non small cell lung cancer coming back after chemotherapy
- How safe olaparib is for people with advanced NSCLC
- More about the side effects of olaparib
- If olaparib can increase the length of time people with advanced NCSLC live
Who can enter
You may be able to enter this trial if you
- Have non small cell lung cancer that is locally advanced (stage 3b) or has spread to another part of your body (stage 4)
- Are going to have chemotherapy that includes either carboplatin or cisplatin
- Have satisfactory blood tests results
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Are willing to use reliable contraception during treatment and for 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 started treatment, or have had treatment, for your cancer – if you have had radiotherapy to control symptoms of cancer spread, and less than a quarter of your bone marrow was treated, you may be able to take part
- Your cancer has spread to your brain or spinal cord unless this has been successfully treated with surgery or radiotherapy
- You have myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML)
- You have had another cancer in the past 5 years unless it was successfully treated with surgery or radiotherapy
- You are currently having another anti cancer drug
- You have had a blood transfusion in the past month and your white blood cells are low
- You have had yellow fever vaccination in the past month
- You have had drugs that work in the same way as olaparib – your doctor can tell you this
- You have certain heart problems
- You have problems with your digestive system that could affect swallowing or absorbing capsules
- You are pregnant or breastfeeding
This is a phase 2 trial. It will recruit 300 people.
This trial is in 2 parts. In the first part everyone will have chemotherapy. After at least 3 treatments of chemotherapy, you have a CT scan to see how well your cancer has responded to treatment.
If the cancer has stayed the same, or continued to grow, your doctor will talk to you about what other treatment there may be. If it has got smaller you can take part in the 2nd part of the trial.
The 2nd part is a randomised trial. You are put into treatment groups by a computer. Neither you nor your doctor can choose which group you are in. Neither of you will know which group you are in. This is called a double blind trial.
- People in group 1 have olaparib
- People in group 2 have a dummy drug (placebo)
Olaparib and the dummy drug are tablets. You take 4 tablets each day, 2 in the morning and 2 in the evening. You swallow them whole with a glass of water.
You have a diary to record when you took your tablets and any side effects you may have.
You continue taking the tablets as long as they are helping you and the side effects aren’t too bad.
While taking olaparib there are certain medicines you shouldn’t take. Your doctor will tell you about this.
The researchers will ask for a sample of your cancer that was removed when you had surgery or a biopsy. You must agree to this to take part in the trial.
You see the doctor to have some tests. These tests include
- A physical examination
- Blood tests
- Urine test
- CT scan
- Heart trace (ECG)
After chemotherapy, you have a CT scan, heart trace and blood tests.
While taking olaparib, or the dummy drug, you see the doctor every 3 weeks for an examination, blood tests and urine tests. You have another heart trace after 9 weeks of treatment. You have a CT scan every 6 weeks for a year, or until your cancer starts to grow again.
You see the doctor a month after finishing treatment for a physical examination and a heart trace.
Olaparib is a new drug and there may be side effects we don’t know about yet. The most common side effects reported include
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
- Feeling or being sick
- Headaches and dizziness
- Loss of appetite
Your doctor will talk to you about the possible side effects of the chemotherapy and olaparib before you agree to take part in this trial.
Location of trial
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
407 St John Street
This is Cancer Research UK trial number CRUK/11/055.
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