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NCI, Foundation Medicine, and Five Pharma Firms Kick off Lung-MAP Trial

NEW YORK (GenomeWeb) — A group of pharmaceutical companies, research groups, foundations, and the clinical sequencing firm Foundation Medicine have joined to initiate a multi-drug, multi-arm, biomarker-driven clinical trial for patients with squamous cell carcinoma called the Lung Cancer Master Protocol, or Lung-MAP.

The public-private collaboration includes support from the National Cancer Institute, the Foundation of the National Institutes of Health, SWOG Cancer Research, and Friends of Cancer Research. It will also involve funding and participation from five pharmaceutical companies: Amgen, Genentech, Pfizer, AstraZeneca, and AstraZeneca’s global biologics R&D arm MedImmune, as well as Foundation Medicine.

The Bonnie J. Addario Lung Cancer Foundation also announced yesterday that it had signed on as a trial collaborator. Other lung cancer advocacy partners include the American Cancer Society, Free to Breathe, Lung Cancer Alliance, LUNGevity, and Uniting Against Lung Cancer.

The study will recruit patients with advanced squamous cell lung cancer — which represents about 25 percent of all lung cancer diagnoses — from over 200 medical centers through the NCI's NCTN and SWOG, the groups said.

According to an announcement by the NCI, researchers in the trial will use Foundation Medicine's technology to screen patients for alterations in 200 cancer-related genes. Based on their results, the group will randomize patients to one of five treatment arms from the pipelines of participating pharma partners or to a control arm matched to each drug.

The targeted treatment arms include four investigational genomically targeted drugs — Amgen's c-MET inhibitor rilotumumab, an AstraZeneca FGFR tyrosine kinase inhibitor, AZD4547, Genentech/Roche's Taselisib, and Pfizer's Palbociclib — as well as one anti PD-L1 immunotherapy, MedImmune's MEDI4736.

The group anticipates that the trial will screen between 500 and 1,000 patients per year.

The NCI's Jeff Abrams said in a statement that the Lung-MAP represents "the first of several planned large, genomically driven treatment trials that will be conducted by NCI's newly formed National Clinical Trials Network."

Unlike traditional clinical trials, the Lung-MAP effort will allow the recruitment of patients with relatively rare genomic alterations to a variety of different targeted therapies at the same time, instead of testing and eliminating patients from individual trials of one targeted drug at a time.

Maria Friere, president and executive director of the FNIH, said that traditional clinical trials "have long imposed significant recruitment and infrastructure burdens on researchers and patients, with frustratingly slow results." The new Lung-MAP trial "will validate biomarkers and facilitate drug development in one infrastructure to more rapidly provide safer and more effective treatments to patients."

According to the NCI's announcement, the trial could be expanded to test as many as five to seven additional drugs over the next five years at a cost of up to $160 million.