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

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

Doctors treat small cell lung cancer with chemotherapy or chemotherapy and radiotherapy (chemoradiotherapy). 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 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

Recruitment

Start 19/09/2013
End 19/09/2015

Phase

Phase 2

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 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
  • 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 of the cervix or breast
  • You have problems with your digestive system 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 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. 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 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.

Find out how to join a trial or contact our cancer information nurses for other questions about cancer by phone (0808 800 4040), by email, or at

The Information Nurses
Cancer Research UK
Angel Building
407 St John Street
London
EC1V 4AD

Chief Investigator

Professor Penella Woll

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

Supported by

AstraZeneca
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Sheffield Teaching Hospitals NHS Foundation Trust
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Updated: 3 June 2014