Lung-MAP: Master Protocol for Squamous Cell Lung Cancer
The Lung Cancer Master Protocol (Lung-MAP), a study launched in 2014, is a clinical trial for patients with advanced squamous cell lung cancer that has not responded to, or has stopped responding to the current standard of care. Squamous cell carcinoma represents about one-fourth of all lung cancer diagnoses, but few treatment options exist once the disease has spread beyond the lungs. This trial will use genomic profiling to assign patients to either a new investigational treatment or a more standard approach. The investigational treatments are specifically selected to target the genomic alterations that may be driving the growth of their cancer.
Each year during the course of the study, the investigators will screen between 500 and 1,000 patients with advanced squamous cell lung cancer for alterations in any of more than 200 cancer-related genes. The results of these screening tests will be used to assign each patient to the trial arm that is best matched to their tumor’s genomic profile if an arm is available.
Patients whose tumor does not match any of the genetic changes that are being tested in the trial may be able to join the “non-match” substudy, or group, in the trial. Patients in this substudy will receive drugs that may help their immune system fight the cancer cells (provided they have not received an immunotherapy drug beforehand). The patients in the substudy will be randomly assigned to one of two groups: nivolumab alone, or nivolumab in combination with ipilimumab. Both offer the drug nivolumab, which is approved for safety and effectiveness by the U.S. Food and Drug Administration for patients with advanced squamous cell lung cancer.
Lung-MAP aims to establish a model of clinical testing that more efficiently meets the needs of both patients and drug developers. Whereas a typical clinical trial for a targeted therapy tests each potential patient for a single biomarker and enrolls only a portion—sometimes a very small portion—of patients tested, Lung-MAP will simultaneously test patients for several biomarkers to assess compatibility with several different experimental treatments. This approach provides patients with a greater likelihood of finding a treatment arm that is specifically studying the genetic alteration found in their tumor; it will also make it possible to add testing of new targeted therapies.
The trial is being conducted at over 500 medical centers by NCI’s National Clinical Trials Network, led by SWOG, and partly funded by NCI through its Cancer Therapy Evaluation Program. Additional organizations participating in this unique public-private collaboration include Friends of Cancer Research, the Foundation for the National Institutes of Health (FNIH), five pharmaceutical companies (Amgen, Genentech, Pfizer, AstraZeneca, and AstraZeneca’s global biologics R&D arm, MedImmune), and Foundation Medicine.
About the Lung-MAP Trial
- Lung-MAP Launches: First Precision Medicine Trial From National Clinical Trials Network
(Posted: June 16, 2014) - A unique public-private collaboration today announced the initiation of the Lung Cancer Master Protocol (Lung-MAP) trial, a multi-drug, multi-arm, biomarker-driven clinical trial for patients with advanced squamous cell lung cancer.
- Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IIIB-IV Non-Small Cell Lung Cancer
(NCT02154490) - This screening and multiple substudy randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-substudy "Master Protocol."
- Lung-MAP Trial Website
The Lung Cancer Master Protocol (Lung-MAP) website provides information for patients and health professionals interested in this precision medicine trial.