The Lung-MAP trial is an innovative biomarker driven 'precision medicine' study which evaluates five novel agents for the treatment of patients with advanced squamous cell carcinoma of the lung. As well as exploring therapeutic options for this indication, it also aims to improve the drug development process.
At a Cytel seminar earlier in the year, Antje Hoering of CRAB presented to delegates on some of the practical challenges of the Lung-MAP study.
The Lung-MAP trial is a multi-drug, multi-sub-study, biomarker-driven squamous cell lung cancer clinical trial. It uses genomic profiling to match patients to sub-studies testing investigational treatments that may target the genomic alterations, or mutations, found to be driving the growth of their cancer. Subjects are tested only once according to a “master protocol” . They are then assigned to one of multiple trial sub-studies ( each testing a different drug.)
The trial represents a unique private- public partnership with multiple stakeholders and therefore inherently very complex. The setup of the original study required a great deal of planning and organization with selection of the platform for biomarker testing, negotiation of the trial design with the NCI and FDA, negotiation of the trial design with the 5 involved pharma companies, and budgets and contracts with all participating organizations.
In the presentation Hoering discusses:
The original trial design
The redesign of the study to take into account therapeutic advances