publication date: Jun. 20, 2014


CL40-25a.html

By Paul Goldberg

SWOG earlier this week started to accrue patients to Lung-MAP, a clinical trial for second-line treatment of non-small cell lung cancer.

The trial, also called Lung Cancer Master Protocol or SWOG S1400, uses the patients’ tumor characteristics to select one of five targeted therapies, comparing them with active control in each arm.

Lung-MAP is funded by a public-private partnership, which combines NCI’s limited funds with those of commercial sponsors, pointing to a new way of pooling resources to conduct faster, more efficient registration trials.

• For patients, Lung-MAP is an opportunity to be directed to therapies chosen from a wider-than-usual menu. Instead of undergoing multiple diagnostic tests to determine eligibility for different studies, patients are tested once, based on a “master protocol,” and assigned to one of five different arms. The control arms are docetaxel or erlotinib, both FDA-approved therapies for second-line treatment of squamous cell non-small cell lung cancer.

• For drug companies, Lung-MAP is an opportunity to earn approval based on a game plan developed and executed with the participation of FDA. (The agency is also represented on the trial’s governing board.) Five agents have been selected for the master protocol: MedImmune’s MED14736, AstraZeneca’s AZD4547, Amgen’s Rilotumumab, Pfizer’s Palbociclib, and a beta sparing PI3 kinase pathway inhibitor from Genentech. These agents could be approved concurrently with the biomarker assays. If any of these compounds fail to meet the endpoints, others will take their place in the ongoing trial. Also, patients treated in the phase II portion of the trial … Continue reading 40-25 Partnership Points to New Path Forward For Drug Approval and Clinical Research

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