NIH Announces Launch of Precision Medicine Trials in Early-Stage Lung Cancer

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The National Institutes of Health (NIH) recently announced the launch of the Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials, or ALCHEMIST. The purpose of the trial, which has three components, is to identify patients with early-stage lung cancer whose tumors harbor certain uncommon genetic mutations and evaluate whether drug treatments targeted against those mutations can lead to improved survival.

The three component trials of ­ALCHEMIST are:

Screening component (A151216), coordinated by the Alliance for Clinical Trials in Oncology; Principal Investigators: Pasi A. Jänne, MD, PhD, and Geoffrey Oxnard, MD, Dana-Farber Cancer Institute, Boston.

EGFR treatment component (A081105), coordinated by the Alliance for Clinical Trials in Oncology; Principal Investigator: Ramaswamy Govindan, MD, Washington University, St. Louis.

ALK treatment component (E4512), coordinated by ECOG-ACRIN; Principal Investigator: David E. ­Gerber, MD, University of Texas Southwestern Medical Center at Dallas.

Study Objectives

“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,” said Shakun Malik, MD, Head of Thoracic Cancer Therapeutics in the Clinical Investigations Branch of the National Cancer Institute (NCI). 

In the ALCHEMIST screening trial, surgically removed tissue will be tested in a central laboratory for certain genetic changes in two genes, ALK and EGFR. Participants with tumors found to harbor EGFR mutations or rearrangement of the ALK gene will then be referred to one of two randomized, placebo-controlled ALCHEMIST treatment trials. These studies will evaluate the value of adding therapy with erlotinib (Tarceva) (targeted against EGFR) and crizotinib (Xalkori) (targeted against ALK), in the postoperative setting.

Support for the Trial

ALCHEMIST is supported by the NCI, with coordination of the component trials by the Alliance for Clinical Trials in Oncology and the ECOG-ACRIN Cancer Research Group. All of the NCI-supported National Clinical Trials Network (NCTN) groups collaborated in the development of ALCHEMIST and are participating in the component trials.

ALCHEMIST is the second precision medicine clinical trial to launch as part of the new NCTN. The first trial, Lung-MAP, for patients with advanced squamous cell lung cancer, was launched in June 2014. ■