Our Stratified Medicine Programme and the National Lung Matrix Trial

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​The Stratified Medicine Programme 2 and National Lung Matrix clinical trials are now closed

 

Our pioneering initiative is bringing the benefits of genetic testing to lung cancer patients and researchers across the UK.

In June 2010 we created the Stratified Medicine Programme 1 to test the feasibility of running a genetic pre-screening programme within existing NHS infrastructure. Following a successful Stratified Medicine Programme 1, we then launched the Stratified Medicine Programme 2. The Programme aims to ensure that the NHS is ready for the new era of precision medicine.

We’re funding the Programme in collaboration with our pharmaceutical partners, AstraZenca and Pfizer. We also joined forces with Illumina, the leading genetic technology experts, to develop the technology needed to support the Programme.

Stratified Medicine Programme 2

Working closely with our funding partners and network of hospitals and genetics labs developed in Stratified Medicine Programme 1, we set the ambitious aim of:

  • Screen up to 2,000 non-small cell lung cancer patients a year to identify the key genetic faults driving the growth of their cancer.

  • Continue to pioneer the use of next-generation sequencing (NGS) technology in the NHS to prove large scale genetic testing works within the NHS.

  • Use this information to match patients to the best treatment option from the multiple “arms” of The National Lung Matrix Trial.

​Trial Design

The Stratified Medicine Programme 2 is an observational pre-screening study led by Professor Peter Johnson. The pre-screening network is made up of all 18 Experimental Cancer Medicine Centres (ECMCs), as well as selected feeder hospitals across the UK.

Late stage lung cancer patients consent for surplus tumour tissue, taken during routine surgery or biopsies, to be sent to Technology Hubs for genetic testing using next-generation sequencing technology. The results determine if the patient is eligible to enter a treatment arm within the National Lung Matrix Trial.

Technology Hubs

Our Technology Hubs are centralised, quality assured molecular diagnostic NHS laboratories in Birmingham (West Midlands Regional Genetics Service), Cardiff (All Wales Medical Genetics Service) and London (The Royal Marsden). They use innovative NGS technology to detect a variety of changes in a patient’s tumour DNA sequence. The NGS panel, consisting of 28 genes, was developed in close collaboration with Illumina, and can be updated regularly to reflect the needs of the programme.

 

The National Lung Matrix Trial

Led by the Cancer Research UK Clinical Trials Unit in Birmingham, this large, non-randomised, multi treatment arm clinical trial is being conducted through the network of 18 ECMCs.

The trial is testing several new treatments, including drug combinations, for patients with non-small cell lung cancer (NSCLC).

Why lung cancer?

  1. Survival rates for lung cancer are still too low and treatment options too limited.
  2. The patient pathway for lung cancer is challenging– if we can succeed here, we can roll out to other tumour types.
  3. With targeted therapies already available or in the pipeline for lung cancer, we can get new treatments to patients straight away.

Aims of the trial

  • To determine which patients benefit most from treatments based on the genetic signature of their tumour, including measurements of tumour shrinkage and drug safety.

  • To assess changes in amounts of ctDNA present in a patient’s blood before, during and after treatment to help identify which changes are linked to drug resistance.

​Trial Design

This is a phase 2 multi-arm, adaptive umbrella trial led by Professor Gary Middleton.

The current target for recruitment is 610. As the trial goes on, the research team may identify other drugs that could benefit people with certain genetic changes. If this happens, new arms will be added to the trial and the number of patients to be recruited may increase. 

Further details of the trial design, including treatment arms, can be found on our clinical trials database.

Watch a short clip about this programme

 

Stratified Medicine Programme 1

Working with AstraZeneca, Pfizer and the UK government's Technology Strategy Board, our aim was to demonstrate how the NHS can provide large scale genetic testing for cancer patients.

Patients from six different cancer indications (melanoma, breast, ovarian, lung, colorectal, and prostate) at one of eight ECMCs (known as Clinical Hubs, at Birmingham, Cambridge, Cardiff, Edinburgh, Glasgow, Leeds, Manchester and The Royal Marsden) were asked for permission to use tissue samples left over from routine surgery.

Their samples were sent to one of three centralised NHS molecular diagnostic laboratories (Technology Hubs) where their DNA was extracted and tested for a set of genetic faults commonly seen in cancer.

Key outcomes

  • Between July 2011 and July 2013, over 10,000 people with melanoma, breast, ovarian, lung, colorectal, and prostate cancer had their tumours tested.

  • Over 8,000 patient records are now securely stored in a research database, with access for researchers.

  • We made the switch from individual gene tests to NGS, to test multiple genes at the same time, saving time and money.

  • The programme established a dedicated, nationwide network of hospitals and individuals experienced in providing genetic testing, laying the foundations for the Stratified Medicine Programme 2.​​

Watch a short clip about this programme

 

Find out more about the Programme

​More information can be found on our Science Blog: