Inclusion criteria for the National Cancer Institute’s (NCI’s) Lung Cancer Master Cancer Protocol (Lung-MAP) trial (ClinicalTrials.org Identifier: NCT02154490) have been expanded to include patients with all types of non-small cell lung cancer (NSCLC), the most common type of lung cancer.1
The Lung-MAP trial, the first precision medicine-based trial supported by NCI, is a phase 2/3 umbrella trial that was originally designed with the intention of accelerating drug development by simultaneously accruing patients with advanced squamous cell NSCLC to 1 of multiple second-line targeted therapy or immunotherapy treatment arms based on results of comprehensive genomic profiling of their tumor specimens.2,3
Beyond changes to eligibility criteria to include patients with all types of NSCLC, the Lung-MAP trial protocol is being modified to include the use of liquid biopsies for the characterization of tumor biomarkers, a streamlined informed consent form, new treatment arms (eg, single-agent PARP inhibitor therapy as well as the combination of a programmed cell death-ligand 1 [PD-L1] inhibitor and a vascular epithelial growth factor [VEGF] inhibitor), and a requirement that all Lung-MAP study sites use the NCI’s Central Institutional Review Board.1
“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,” said Meg Mooney, MD, acting associate director of the National Cancer Institute’s Cancer Therapy Evaluation Program. “Checkpoint inhibitors have produced a major advance in this refractory cancer, and Lung-MAP now intends to build on the success of these immunotherapy agents by adding new agents to further increase the effectiveness of this approach.”1
- Foundation for the National Institutes of Health. LUNG-MAP precision medicine trial expands to include more patients. https://www.prnewswire.com/news-releases/lung-map-precision-medicine-trial-expands-to-include-more-patients-300785281.html?tc=eml_cleartime. Published January 29, 2019. Accessed January 30, 2019.
- Lung-MAP. https://www.lung-map.org/about-lung-map. Accessed January 30, 2019.
- Herbst RS, Gandara DR, Hirsch FR, et al. Lung Master Protocol (Lung-MAP)—a biomarker-driven protocol for accelerating development of therapies for squamous cell lung cancer: SWOG S1400. Clin Cancer Res. 2015;21(7):1514-1524.