publication date: Mar. 27, 2015

How the Lung-MAP Clinical Trial is Responding to Rapidly Changing Science


When the Lung Master Protocol clinical trial (Lung-MAP or S1400) (1) was launched in June 2014, the goal of this first-of-its kind trial was simple: find effective treatments for seriously ill patients suffering from a specific type of lung cancer.

Lung-MAP is unique—a biomarker driven, multi-drug, multi-arm, study design, using a targeted screening approach, with state-of-the-art genomic profiling of neoplastic cells to match patients with sub-studies testing investigational new drugs and immunotherapies, based on their unique tumor profiles.

The matched drug treatments are designed to target genomic alterations driving the growth of the cancer.

Lung-MAP was conceived with the premise that new ways of thinking were required to advance drug-biomarker combinations for lung cancer.

It had become clear that the old paradigm of “all comer” phase III trials was largely unproductive, with few drugs making it through the approval process, and those that did weren’t having a major impact. It was anticipated early on that an essential component of the project would be the ability to rapidly adapt to changes in the therapeutic landscape, including changes in standards of care.

This vision has never been clearer than these past weeks with the approval of nivolumab (Opdivo) in the second line therapy of squamous cell lung cancer (SCC), the same research space occupied by Lung-MAP (The Cancer Letter, March 6).

While the rapid approval of nivolumab represents success for an exciting new therapy, we still have much to learn. Immunotherapies, including … Continue reading 41-12 How the Lung-MAP Clinical Trial is Responding to Rapidly Changing Science

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