Trialling personalised cancer medicine

The challenge

Non-small cell lung cancer is the most common type of lung cancer. However, as it is caused by a range of specific mutations which vary between patients, individuals won’t all respond in the same way to the same treatment. This presents a clear opportunity for the use of precision medicine – however, setting up numerous individual clinical trials can be a barrier as it is inefficient in terms of patient care and investment in trial delivery.

The solution

With both strong NHS partnerships and the country’s largest Cancer Research UK Clinical Trials Unit (CRCTU), Birmingham is home to significant expertise in early phase trials and complex methodology – as well as a diverse population with a high prevalence of cancer. Coupled with extensive experience in genetic and genomic testing and patient stratification, all the elements of success were aligned.

The team devised an ambitious phase II non-randomised umbrella trial, initially evaluating seven targeted drugs across 20 different biomarker-defined cohorts. This trial – the National Lung Matrix Trial – also includes an arm for the population with no actionable genetic change who will be treated with a sequential pipeline of drugs. Through the CRCTU team’s in-depth knowledge of the complex biology underpinning the trial, they have been able to identify eligible patient recruits based on molecular targets outlined in the Cancer Research UK (CRUK) Stratified Medicine Programme 2. The initial target for recruitment was 30 patients for each drug-biomarker cohort, with rollout across the UK’s 18 Experimental Cancer Medicine Centres – including Birmingham’s Queen Elizabeth and Heartlands hospitals.

Progress

To date, over 300 patients have been recruited to the trial with some reaching their formal planned interim analysis, and work continues to achieve the trial’s primary objective – to evaluate whether there is sufficient signal of activity in any drug-biomarker combination to warrant further investigation. A secondary objective is to provide industry partners with the opportunity to test novel agents in the ‘no actionable genetic change’ arm, which could inform the design of future drug trials.

Although the National Lung Matrix Trial is still ongoing, it has been presented at national and international conferences and has been received with enthusiasm by the lung cancer community and statistical methodologists.

Aligned with CRCTU’s strategic objectives – to enhance the delivery of personalised medicine for cancer patients – this trial ably demonstrates our ability to support this challenging endeavour.

For further information, visit the National Lung Matrix Trial website.