NIH Begins Genetic Testing Trial For Stage IB-IIIA Non-Small Cell Lung Cancer

The National Institutes of Health (NIH) announced in a press release that it has launched a genetic testing trial to identify genes in stage IB-IIIA non-small cell lung cancer (NSCLC) tumors that have been or will be removed by surgery. The ALCHEMIST study, which is being carried out at the Dana-Farber Cancer Institute in Boston, Washington University in St. Louis, and the University of Texas Southwestern Medical Center in Dallas, consists of three components – screening, EGFR treatment, and ALK treatment. The National Cancer Institute (NCI) will conduct the study.

Shakun Malik, M.D., of the National Cancer Institute (NCI), said, “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.”

ALCHEMIST Study

The ALCHEMIST study (Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials) will study the genes in stage IB-IIIA non-small cell lung cancer tumors in order to target treatments. Since some tumors with genetic variations are uncommon, targeted drug treatments can lead to improved survival. NCI, the Alliance for Clinical Trials in Oncology, and the ECOG-ACRIN Cancer Research Group will participate.

For patients to participate, they must have their tumors surgically removed, be diagnosed with lung adenocarcinoma, and begin standard chemotherapy or radiation therapy. In the first component of the trial, researchers will test the tumors for ALK and EGFR genetic changes. If EGFR or ALK mutations or rearrangements exist, the patient will be referred to the second and third component of the study.

The placebo-controlled treatment arms will test erlotinib for EGFR and crizotinib for ALK. Both treatments are Food and Drug Administration (FDA) approved for advanced forms of lung cancer with genetic alterations. The trial will test if ALK and EGFR patients that are clinically free of disease will respond to erlotinib or crizotinib. Investigators hope to prevent lung cancer recurrence and prolong life. 

Alterations in the EGFR gene occur in the U.S. at a rate of 10 percent and a rate of 5 percent for the ALK gene. Researchers hope to screen about 8,000 patients at multiple sites for five to six years for a completed group of 800 patients. Investigators will follow all enrollees for five years while they receive the best care for their condition.