publication date: Jun. 5, 2015

Past Coverage of Next-Generation Clinical Trials

“Master Protocol” To Rely on Biomarkers in Testing Multiple Lung Cancer Agents

A new kind of clinical trial that will assign patients to therapy based on molecular characteristics of their disease is being launched by a coalition of government agencies, pharmaceutical companies, and a non-government organization.

The effort, called the lung cancer “Master Protocol,” is a phase II and phase III trial that would test five drugs, assigning patients to therapy based on tumor biomarkers.

The master protocol in advanced squamous cell lung cancer (S1400) is one of at least three next-generation trials now in the works at NCI and its clinical trials cooperative groups.

NCI Launches M-PACT Next-Generation Trial As Group System Nears March 1 Transition

NCI has launched a pilot study to assess whether assigning cancer patients treatment based on the genetic characteristics of their disease can improve outcomes for patients with advanced metastatic solid tumors.

The Molecular Profiling based Assignment of Cancer Therapeutics, or M-PACT, trial is one of the first to use a randomized trial design to assign treatment based on specific mutations.

Initially launched at NCI, the trial will eventually be opened to researchers in the institute’s Early Therapeutics Clinical Trials Network. The plan is to report results by 2017.

photoPartnership Points to New Path Forward For Drug Approval and Clinical Research

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.



NCI launched another in a series of targeted treatment trials referred to as the Adjuvant LungCancer Enrichment Marker Identification and Sequencing Trial.

ALCHEMIST seeks to identify mutations in early-stage lung cancer patients, and uses this information to assign them to treatments targeted for those mutations.


NCI Starts “Exceptional Responders” Study

NCI has launched a pilot study to investigate the molecular factors of tumors associated with exceptional treatment responses of cancer patients to drug therapies,

The Exceptional Responders Initiative seeks to identify the molecular features of tumors that predict whether a particular drug or class of drugs will be beneficial. 

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