Sites Revealed for Lung Cancer Precision Diagnostic Trial

(NIH.gov)

3 June 2022. The first sites are selected for a study testing people with suspected lung tumors for cancer-causing mutations, to help decide on personalized treatments for their disease. The clinical trial is sponsored by the Lung Cancer Mutation Consortium, or LCMC, a group of 20 cancer centers in the U.S., underwritten by the Lung Cancer Research Foundation in New York.

LCMC says medical centers at University of Southern California in Los Angeles, University of California in Davis, University of Michigan in Ann Arbor, and University of Washington in Seattle are taking part in the trial, with the number of sites expected to grow to at least 20. The prospective study is enrolling 1,000 participants suspected of non-small cell lung cancer, or NSCLC, that can be removed by surgery but before starting treatment. NSCLC accounts for 80 to 85 percent of all lung cancer cases.

“This effort is an important next step,” says lung cancer specialist Mark Kris with Memorial Sloan Kettering Cancer Center in New York, in an LCMC statement, “to expand the benefits of targeted treatment to patients with early-stage lung cancers. Comprehensive genomic profiling offers critical insights that allow oncologists to select the best treatments for each individual person.” Kris, one of the lead investigators in the trial, and a colleague are scheduled to describe the study on 6 June at the annual meeting of American Society of Clinical Oncology in Chicago.

Looking for 11 known cancer-causing mutations

Participants will give biopsy-tissue and blood samples for genomic tests made by Foundation Medicine in Cambridge, Mass., called FoundationOne CDx and LiquidCDx respectively, that analyze the samples for mutations known to cause solid tumor cancers. Science & Enterprise reported in Dec. 2017 on Food and Drug Administration’s authorization of the FoundationOne CDx test for solid tumor cancers that help identify the most promising available therapies matched to a tumor’s genetic mutations.

In this trial, the tests are designed to provide evidence for physicians to decide on next treatments for patients, called neaoadjuvant therapies, initial steps to shrink tumors before the main treatments, such as surgery. The study team identifies 11 known cancer-causing mutations or other genetic alterations that can serve as targets for the next round of therapies for patients. A group of lung cancer surgeons is working with the researchers to enroll participants in this trial, as well as match test results to precision-medicine cancer therapy clinical studies where appropriate.

The clinical trial’s main outcome measure is percentage of participants found with one or more of the 11 actionable genetic mutations or alterations. The study’s organizers expect about a third of participants to show at least one of these genetic conditions. Remaining participants will be candidates for other neoadjuvant therapies, including immune checkpoint inhibitors. The study team is also tracking tumor burden in patients for eight weeks following testing.

“The neoadjuvant setting is a rapidly evolving space for the development of precision treatment options in lung cancer,” says Geoff Oxnard, vice president of Foundation Medicine in a company statement. “Enabling trials in this setting will continue to help us understand the impact of targeted therapies in the curative treatment of NSCLC.”

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