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The Lung Cancer Master Protocol (Lung-MAP): A re-vamp of the clinical trials system?

06/18/2014

We all know that that our clinical trials system is not working as it is. A strong body of evidence suggests that the one test, one drug model is inefficient and expensive; and that a very low percentage of patients are even being made aware of, let alone participating in, clinical trials. When you consider the challenges of running trials for increasingly smaller, more targeted populations – as is the case with personalized medicines – the obstacles to bringing new therapies to patients who need them can seem overwhelming.

But last week brought forth an exciting example of what is possible if we expand options to patients in a meaningful way. The Lung Cancer Master Protocol (Lung-MAP) trial is a newly opened, multi-drug, targeted screening approach that matches patients with promising new treatments based on their unique tumor profiles. As Bonnie Addario, founder & chair of the Bonnie J. Addario Lung Cancer Foundation, put it: “For the first time, a biomarker-driven lung cancer clinical trial will begin with the patient as the focus of the trial, and personalizing therapy to the specific mutations in their tumor, unlike the traditional method of focusing on the drug and testing who responds to it.”

Lung-MAP was first proposed at the 2012 Conference on Clinical Cancer Research hosted by Friends of Cancer Research and the Brookings Institution. Friends, in conjunction with its government and industry partners, then developed a clinical trial design in a series of workshops, forums, and working groups.

Last Wednesday, two days after Lung-MAP first began enrolling patients, FasterCures’ LaTese Briggs moderated a Webinar with three of the trial’s founding partners to discuss the impressively rapid establishment of this potentially transformative public/private partnership.

“This trial gives patients a seat at the table that is not just symbolic, but substantive,” said Friends’ Ellen Sigal. She pointed out that while the rise of personalized medicine has improved many aspects of patient care, it has also exacerbated the challenges of running a clinical trial. Initially inspired by feedback from the FDA, the partners each recognized the unmet need and collectively sought to reach consensus on the design of a biomarker-driven, multi-drug, multi-arm Phase 2/3 registration trial in squamous cell lung cancer.  “It came together because we all worked together.”

Through the joint efforts of the National Cancer Institute (NCI), Friends of Cancer Research, SWOG Cancer Research, the Foundation for the National Institutes of Health, five pharmaceutical companies (Amgen, Genentech, Pfizer, AstraZeneca, and AstraZeneca’s global biologics R&D arm, MedImmune), and Foundation Medicine, The Lung-MAP clinical trial seeks to change and accelerate the way new therapies are tested and approved and serve as a model for how future clinical trials can be conducted.

The study will identify “actionable” molecular abnormalities in tumor specimens from thousands of patients with squamous cell lung cancer. The protocol allows doctors at medical centers to enroll their patients locally. Meanwhile tumor samples will be checked in a central lab for hundreds of potential abnormalities. Patients are assigned to an investigative arm based on their tumor’s profile, which raises the likelihood of a response.

“We look at over 200 different genes, different genetic alterations, and different abnormalities in a tumor that are potentially driving that tumor; because if we’re going to knock out that tumor, we want to find its Achilles heel” said Roy Herbst of the Yale Cancer Center.

What makes this process especially unique is that instead of having to undergo multiple diagnostic tests to determine eligibility for many different studies, enrollees are tested just once. And the speed with which it was developed – from the initial white paper in February of 2012 to enrollment opening in June of 2014 – is all but unprecedented.

“When we knew we were going to put this partnership together, we realized we would have to rise to the challenge of really making things much more efficient and streamlining.  We were able to get this trial open for enrollment very rapidly by any standards,” noted National Cancer Institute’s Jeffrey Abrams.

The founders hope the study will break down of the traditional barriers that keep patients out of clinical trials, and will serve as a model for other therapeutic areas.

Read more about Lung-MAP: