A trial looking at olaparib for non small cell lung cancer (PIN)

Cancer type:

Lung cancer
Non small cell lung cancer

Status:

Open

This trial is looking at olaparib for non small cell lung cancer. It is for non small cell lung cancer (NSCL) 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 Open a glossary item 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 Open a glossary item).

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 Open a glossary item 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 Open a glossary item (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 Open a glossary item 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 Open a glossary item that could affect swallowing or absorbing capsules
  • You are pregnant or breastfeeding

Trial design

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)

PIN trial diagram

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 Open a glossary item. You must agree to this to take part in the trial.

Hospital visits

You see the doctor to have some tests. These tests include

  • A physical examination
  • Blood tests
  • Urine test
  • CT scan
  • Heart trace (ECG Open a glossary item)

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.

Side effects

Olaparib is a new drug and there may be side effects we don’t know about yet. The most common side effects reported include

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

Barrow in Furness
Birmingham
Blackpool
Bradford
Burton on Trent
Cardiff
Coventry
Derby
Haverfordwest
Huddersfield
Leeds
Leicester
London
Maidstone
Manchester
Middlesbrough
Preston
Sheffield
Wrexham

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

Professor Dean Fennell

Supported by

AstraZeneca
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Velindre NHS Trust

Other information

This is Cancer Research UK trial number CRUK/11/055.

We have more information about the work of Prof Dean Fennell.

Contact our cancer information nurses for other questions about cancer by:

Phone - 0808 800 4040

Last review date

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

Charlie took part in a trial to try new treatments

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

Last reviewed:

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