PIN: A Trial Looking At Olaparib For Non Small Cell Lung Cancer

In 2013, there were 45,525 new cases of lung cancer in the UK and it kills around 35,000 annually (Source: CRUK). Non-small cell lung cancer (NSCLC) accounts for around 87% of all lung cancer. NSCLC is one of the leading causes of death worldwide and presents a huge health economic burden. The majority of patients with NSCLC present with locally advanced or metastatic (stage IIIB/IV) disease. Chemotherapy is one of the main treatments for patients with advanced NSCLC but those treated median survival remains modest, at around 9-10 months.

Assessing The Benefits Of Olaparib For Maintenance Therapy

The PARP Inhibitor in advanced NSCLC (PIN) study, funded by Cancer Research UK and AstraZeneca and sponsored by Velindre NHS Trust, seeks to address advanced lung cancer, which is a significantly under-researched cause of cancer death.

The purpose of this clinical trial is to find out whether or not giving a drug called Olaparib following chemotherapy will benefit patients with NSCLC who have responded to initial chemotherapy treatment. 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.

Olaparib may offer a potentially effective and less toxic cancer treatment compared to currently available chemotherapy regimens. A recent UK trial of maintenance Olaparib (treatment with Olaparib following completion of induction chemotherapy) in patients with ovarian cancer met its primary endpoint of progression-free survival.

We know that a proportion of non-small cell lung cancers are sensitive to DNA damage (around 30%), and that these tumours will harbour defective DNA repair mechanisms resulting from specific mutations or loss of specific proteins such as BRCA1. By identifying patients who have responded to chemotherapy with tumour shrinkage, this “biomarker” will be used to select patients for enrolment into the PIN trial.

Trial Outcomes

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

Eligibility Criteria

One hundred and fourteen patients in hospitals across the UK who have responded to chemotherapy will be invited to take part in the trial. Patients will be randomly allocated to receive either Olaparib or an inactive dummy ‘placebo’ tablet by mouth. To be eligible to enter the trial patient must meet the following criteria:

• Have non small cell lung cancer that is locally advanced (stage 3b) or has spread to another part of your body (stage 4)
• Have had a response to 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

Trial Sites

The trial is offered in the following hospital sites:

1. University Hospital of Leicester
2. Royal Lancaster Infirmary
3. Withybush Hospital
4. Royal Preston Hospital
5. Maidstone and Tunbridge Wells NHS Trust
6. Queens Hospital
7. Huddersfield Royal Infirmary
8. The James Cook University Hospital
9. Wrexham Maelor
10. Velindre Cancer Centre
11. Birmingham Heartlands Hospital
12. St James University Hospital
13. Bradford Royal Infirmary
14. University Hospitals Coventry and Warwickshire
15. Blackpool Victoria Hospital
16. Weston Park Hospital
17. Christie NHS Foundation Trust
18. Charing Cross Hospital
19. Derby Royal Infirmary
20. Beatson West of Scotland Cancer Centre

How To Join A Clinical Trial

In order to join this trial, any potential participant would need to discuss it with their doctor.

Further information about the PIN trial is available on the CRUK website.