SMP2 and NLMT programme updates

Both the CRUK Stratified Medicine Programme (SMP2) and the National Lung Matrix Trial (NLMT) are at a crucial phase of trial delivery.

SMP2 and NLMT are open to recruitment at 17 and 16 ECMCs respectively. Both study teams are collaborating to set up three new sites (Liverpool, Maidstone and Devon and Exeter) as part of a phased approach that aims to introduce several new sites across the country.

SMP2 has recently completed the fifth comprehensive sample and data audit. The team will shortly be distributing audit reports to enable sites to identify areas for improvement. Performance across the network is steadily improving, and their focus now is to challenge sites to test as many patients as possible through SMP2 and carefully track eligible patients through to NLMT. We need commitment and support from the entire ECMC network to increase recruitment and maximise translation between SMP2 and NLMT, to ensure that this study continues to deliver. 

The SMP2 team has been working closely with Illumina, our genetic technology provider and the three Technology Hubs/genetic testing laboratories, to develop a new and improved version of the 28-gene NGS panel. The new version, launched on 20 March 2017, features increased probe coverage, particularly in poorly performing regions, to reduce the gene fail rate and the addition of gene regions to the panel to allow new drug treatments to be delivered via NLMT. These improvements should mean that a higher proportion of patients receive a more meaningful result from their first sample, increasing the number of patients molecularly eligible for NLMT without the need for a repeat biopsy or repeat sample being tested. 

As at 9 June 2017, 151 patients have been registered to the NLMT. Patients have received treatment on each of the eight investigational medicinal products provided by either AstraZeneca or Pfizer, within 20 of the 21 distinct cohorts. 125 of these patients have received targeted treatments within the NLMT. 

One of the original seven targeted treatment arms, Arm G – osimertinib, was closed to recruitment in December 2016, as this drug is now licensed and available via the Cancer Drugs Fund for this cohort of patients. Three arms – B2, C6 and NA1 – have reached interim analysis. 

Three new biomarker-drug trials (Arms H-J) targeting aberrations in genes on the panel that are currently not targeted by any existing arms, and a second non-actionable cohort (NA2) have received funding approval for inclusion in the NLMT. These are to be provided by two new pharmaceutical partners which will be announced shortly. The NLMT team have received confirmation of the Phase II doses for Arm H and cohort NA2, and a substantial amendment to the protocol is therefore under development.

The SMP2 Team can be contacted at precisionmedicine@cancer.org.uk.

The NLMT Team can be contacted at lungmatrix@trials.bham.ac.uk.