STOMP: SCLC Trial of Olaparib (AZD2281) as Maintenance Programme.

• Research type

  Research Study

• Full title

  STOMP: Small cell lung cancer Trial of Olaparib (AZD2281) as Maintenance Programme: a randomised, double blind, multicentre phase II trial

• IRAS ID

  56786

• Contact name

  Penella J Woll

• Sponsor organisation

  Sheffield Teaching Hospitals NHS Foundation Trust

• Eudract number

  2010-021165-76

• ISRCTN Number

  ISRCTN73164486

• Research summary

  Summary of Research
  Small cell lung cancer (SCLC) accounts for about 3,500 new cases a year in the UK. Although about 80% of cases do initially respond to treatment using chemotherapy, the majority of patients later relapse and die within 2 years of diagnosis. The standard first line chemotherapy treatment, with 2 drugs (a platinum drug and another drug called etoposide) has been unchanged for 20 years. So new treatments are urgently needed. The purpose of the STOMP trial is to find out how effective a new drug, called Olaparib, is, compared to a placebo treatment when given in addition to the standard treatment for patients with small cell lung cancer. Recent evidence suggests that some cancer cells can be susceptible to a new type of drug that can slow or stop the resistance to the standard chemotherapy. Olaparib is one of these new drugs and this trial will look at the effects on patients when they have Olaparib after they have already had the standard chemotherapy. Because this is a new treatment the side-effects of the drug will be looked at closely, as well as any effect the drug may have in delaying or stopping relapse. Patients with SCLC that has responded to primary treatment with chemotherapy and radiotherapy will be eligible. Consenting patients will receive olaparib or matching placebo by mouth each day for up to two years. They will attend clinic each month and be monitored with blood tests, x-rays and CT scans.

  Summary of Results
  WHAT WERE THE RESULTS OF THE STUDY?
  This is a summary of the main results from this study. These are the results from all the participants combined. The individual results of each participant might be different and are not in this summary.
  The study started in November 2013 and ended in December 2020. The study included 220 participants recruited in hospitals throughout the UK:
  o 74 people had dummy drug (placebo) either 2 or 3 times a day
  o 73 people received olaparib twice a day
  o 73 people receive olaparib 3 times a day
  After an average follow up of just over 3 years, the trial team looked at the average time it took before the cancer got worse. They found that it was not significantly different between the tested groups.
  The team also looked at the average length of time people in each group lived. Again, they found that there were no differences between placebo and olaparib.
  The trial team also analysed the adverse effects on each group. The most common problems reported by patients taking olaparib were feeling tired, feeling or being sick, a drop in the number of cells in their blood, and loss of appetite.
  Out of 220 recruited, 214 patients stopped treatment before completing 2 years. In most cases (58%) this was because their cancer came back. However, 66 patients reported that adverse events were the main reason to stop taking the trial treatment (18 taking placebo, 24 taking olaparib twice a day, 24 taking olaparib 3 times a day).
  A medical problem reported during a clinical trial that puts the participant’s life at risk, requires hospitalization, causes disability, causes a baby being born with medical problems, or may have turned into one of these problems if not treated, is called a serious adverse event. These may be related to the patient’s disease, trial treatment or other causes.
  Serious adverse events were reported for 73 patients: 29 events in 23 patients on placebo), 26 events in 21 patients taking olaparib twice a day, and 43 events in 29 patients taking olaparib 3 times a day. As illustrated by these numbers some participants had more than 1 serious event. However, only 33 of these were considered to be likely related to the study treatments.

  HOW HAS THIS STUDY HELPED PATIENTS AND RESEARCHERS?
  The results of this study have helped researchers learn more about using olaparib in patients with small cell lung cancer. The results might be used when designing other studies using olaparib or planning to find new treatments for people who have a similar condition.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  11/YH/0290

• Date of REC Opinion

  31 Aug 2011

• REC opinion

  Further Information Favourable Opinion