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NCI Launches Molecular Medicine Clinical Trials; Response Genetics Nabs Profiling Contract

NEW YORK (GenomeWeb) – The National Cancer Institute said today it has launched new clinical trials that will use tumor sequencing and genetic markers to help determine whether therapies targeting genetic alterations can prevent lung cancer recurrence.

Separately, Response Genetics said it has been awarded a "multi-million dollar" subcontract from Leidos Biomedical Research, a contractor for the NCI-sponsored Frederick National Laboratory for Cancer Research, to handle molecular profiling for the trials. Further details about the subcontract's terms were not immediately available.

The Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials, or ALCHEMIST, will examine between 6,000 and 8,000 lung cancer patients over a five- or six-year period to identify which participants have EGFR gene mutations and ALK gene rearrangements. The patients will then be stratified into two separate randomized trials that will evaluate the use of erlotinib and criotinib — therapies that target these alterations — after tumors have been removed by resection.

Both of these drugs are already approved by the US Food and Drug Administration for treating patients with advanced forms of lung cancer whose tumors harbor these alterations. What the ALCHEMIST study now aims to find out is whether they can help prevent the cancer from returning, and prolong patient lives.

This project also will try to define the biologic and molecular progression of early-stage lung cancer, evaluate therapies in the adjuvant setting, and provide a public resource that connects patients' genomic characterization with detailed clinical and epidemiological data and long-term outcomes.

The screening trial will be led by investigators at Dana-Farber Cancer Institute. The EGFR treatment component of the trial will be headed by researchers at Washington University, St. Louis, and the ALK trial will be led by scientists at the University of Texas Southwestern Medical Center at Dallas. The project is supported by NCI, along with coordination from the Alliance for Clinical Trials in Oncology and the ECOG-ACRIN Cancer Research Group.

"We believe that the findings from ALCHEMIST will not only help answer an important question about the addition of targeted therapies in earlier stage disease but will also help us in understanding the prevalence and natural history of these genomic changes in earlier stage lung cancer. We also hope to gain a better understanding regarding the genetic changes in the tumor at the time of recurrence," Shakun Malik, head of Thoracic Cancer Therapeutics in NCI's Clinical Investigations Branch, said in a statement. "The findings will help to define clinical, biologic, and molecular behaviors of this type of lung cancer."

The ALCHEMIST trial is the second precision medicine trial to launch as part of the new National Clinical Trials Network; the first was the Lung-MAP project targeting squamous cell lung cancer, which launched earlier this year.

Regarding Response Genetics' involvement in the trials, Geoffrey Oxnard, a physician at Dana-Farber and co-principal investigator for ALCHEMIST, noted that "as an organization with a focus on lung cancer genomics and an interest in facilitating clinical research, Response Genetics is a good choice to perform the central genotyping for ALCHEMIST. The Response Genetics team has been an asset on another lung cancer trial I lead which studies inherited EGFR mutation, and I am confident they will add value to this important program."

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