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January 30, 2019

Umbrella trial for lung cancer precision medicine expands access

A precision medicine clinical trial for lung cancer, featuring umbrella design, has been opened to individuals with all types of non-small cell lung cancers.

Dubbed Lung Cancer Master Protocol (Lung-MAP), the trial was initially open for advanced stage squamous cell lung cancer patients.

The trial, which is backed by the National Cancer Institute (NCI), is designed to simultaneously assess multiple investigational drug candidates under a single umbrella module.

Lung-MAP is said to be more flexible and faster, compared to standard clinical trial models, as it uses a ‘master protocol’ that is adjusted based on drugs entering and exiting the trial.

This maintains the trial’s infrastructure and patient outreach efforts, making it efficient and cost-effective.

It is being conducted through a public-private alliance involving the NCI, its National Clinical Trials Network (NCTN), and the Foundation for the National Institutes of Health (FNIH), among others.

The investigational treatments will be supplied by respective pharmaceutical companies.

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Apart from the expanded access, the Lung-MAP’s screening protocol will receive an upgrade to include liquid biopsies and consent forms combining screening and prescreening for easier patient enrolment.

Four new sub-studies are also scheduled to open over the coming months. One of the sub-studies will test a PARP inhibitor, while another will evaluate a PD-L1 and VEGF inhibitor combination.

Furthermore, a new requirement will be added for the use of NCI’s Central Institutional Review Board by any clinical sites that open the trial.

A new measure will also be taken to accelerate the process of trial opening and registering patients.

NCI Cancer Therapy Evaluation Program acting associate director Meg Mooney said: “The Lung-MAP trial has already proven its value by successfully completing trials with new targeted agents in selected, molecularly defined subsets of squamous cell lung cancer. This amendment to the trial will allow patients with all types of non-small cell lung cancer to potentially benefit.”

Launched in June 2014, Lung-MAP has registered more than 1,700 US patients till date. Being conducted at more than 650 sites, the trial includes nine studies, six of which are complete.

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