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

Cancer type:

Lung cancer
Small cell lung cancer

Status:

Open

This trial is looking at olaparib for people with small cell lung cancer (SCLC) who have already had one other treatment. This trial is supported by Cancer Research UK.

Doctors treat small cell lung cancer with chemotherapy or chemotherapy and radiotherapy (chemoradiotherapy Open a glossary item). Unfortunately it may come back afterwards. The researchers want to see if olaparib can delay or prevent SCLC coming back after the first line treatment. This is called maintenance therapy.

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.

In this trial some people will have olaparib and some people will have a dummy drug (placebo).

The aims of this trial are to find out

  • If olaparib can be used as maintenance therapy for people with SCLC
  • If olaparib can increase the length of time people live
  • How safe olaparib is as maintenance therapy for SCLC

Who can enter

You may be able to enter this trial if

  • You have small cell lung cancer (SCLC)
  • You have had at least 3 cycles of chemotherapy or chemoradiotherapy Open a glossary item with cisplatin, or carboplatin with etoposide
  • On a scan, your cancer had shrunk or there was no sign of it after treatment – your doctor can confirm this
  • You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • Your blood test results are satisfactory
  • You are able to swallow tablets
  • You 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
  • You are at least 18 years old

You cannot enter this trial if

  • Your radiotherapy started more than 5 weeks after your last cycle of chemotherapy
  • Your last treatment of radiotherapy was more than 3 weeks ago
  • The start of your last cycle of chemotherapy was more than 6 weeks ago
  • You still have moderate to severe side effects from your treatment apart from hair loss
  • Your cancer has spread to your brain and you have symptoms that aren’t controlled
  • You have a non cancerous disease of your lung tissue or the space surrounding the air sacs of your lungs (called interstitial lung disease) – your doctor can confirm this
  • You have had another cancer in the past 3 years apart from successfully treated non melanoma skin cancer or in situ carcinoma Open a glossary item of the cervix or breast
  • You have problems with your digestive system Open a glossary item that could affect how you absorb tablets
  • You have had an experimental drug as part of a clinical trial in the past 2 weeks
  • You have already had olaparib or another PARP inhibitor – your doctor can confirm this
  • You are having certain medications that affect body proteins called CY3P enzymes – your doctor can advise about this
  • You have had a heart attack in the past 3 months or have any other medical condition that could affect you taking part in this trial
  • You are HIV, hepatitis B or hepatitis C positive
  • You have uncontrolled fits (seizures)
  • You have myelodysplastic syndrome Open a glossary item or acute myeloid leukaemia (AML) – the trial team will test for these
  • You have had major surgery in the past 2 weeks or haven’t recovered from major surgery
  • You are allergic to olaparib or its ingredients
  • You are pregnant or breastfeeding

Trial design

This is a phase 2 trial. It will recruit 222 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. And neither of you will know which group you are in. This is called a double blind trial. The groups are

  • People who have 2 olaparib tablets 3 times a day
  • People who have 3 olaparib tablets twice a day
  • People who have 2 dummy tablets 3 times a day
  • People who have 3 dummy  tablets twice a day

STOMP trial diagram

Olaparib and the dummy drug are tablets. You take them every day for 2 years.

If your cancer comes back during the 2 years, you stop taking the olaparib or dummy drug. Your doctor will talk to you about other treatment that may be available to you.

If you have very bad side effects the doctor can reduce the number of tablets you take.

The trial team will ask you to fill out a questionnaire before you start treatment, every month during treatment and after you finish 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 study, the researchers will ask for 3 extra blood samples during the trial and for a sample of your cancer that was removed when you had surgery or a biopsy Open a glossary item. If you don’t want to give these samples for research, you don’t have to. You can still take part in the trial.

Hospital visits

You see the doctor to have some tests before taking part in this trial. These tests include

  • A physical examination
  • Blood tests
  • CT scan
  • Chest X-ray

During treatment you see the doctor every month for the same tests, apart from the CT scan which you have every 2 months.

After treatment you see the doctor every 3 months.

Side effects

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

Location

Aberdeen
Airedale
Birmingham
Bournemouth
Bradford
Bristol
Burton on Trent
Cambridge
Cardiff
Derby
Eastbourne
Edinburgh
Exeter
Glasgow
Harrogate
Huddersfield
Inverness
Leeds
Leicester
Lewisham
Lincoln
London
Maidstone
Manchester
Morecambe
Nottingham
Orpington
Plymouth
Sheffield
Southampton
St Leonards-on-sea
Sutton
Wolverhampton

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 Penella Woll

Supported by

AstraZeneca
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Sheffield Teaching Hospitals NHS Foundation Trust

Other information

This is Cancer Research UK trial number CRUK/10/037.

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.

Wendy took part in a new trial studying the possible side effect of hearing loss

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

Last reviewed:

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