NIH Launches Three Integrated Precision Medicine Trials

The Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials, or ALCHEMIST, has been launched to identify early-stage lung cancer patients with tumours that harbor certain uncommon genetic changes and evaluate whether drug treatments targeted against those changes can lead to improved survival.

“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 as well regarding the genetic changes in the tumour 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). “The findings will help to define clinical, biologic and molecular behaviors of this type of lung cancer.”

ALCHEMIST is supported by the NCI, part of the National Institutes of Health, with co-ordination 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.

People enrolled in ALCHEMIST will need to undergo surgical removal of their tumours; have been diagnosed with lung adenocarcinoma or similar types of lung cancer as identified by examining the tissue; and will need to complete standard therapy after surgery, consisting of chemotherapy with or without radiation therapy as prescribed by their physician.

In the ALCHEMIST screening trial, the surgically removed tissue will be tested in a central laboratory for certain genetic changes in two genes, ALK and EGFR. Participants with tumours found to harbor EGFR mutations or rearrangement of the ALK gene will then be referred to one of two randomised, placebo-controlled ALCHEMIST treatment trials. These studies will evaluate the value of adding therapy with specific agents targeted against two genetic alterations, erlotinib (EGFR) and crizotinib (ALK), in the post-operative setting. FDA has approved these drugs for the treatment of patients with advanced forms of lung cancer whose tumours harbor the targeted genetic alterations. However, it is not known if these agents will be beneficial when administered to patients who are clinically free of disease. The goal of the trials is to determine whether erlotinib or crizotinib will prevent lung cancer recurrence, as well as prolong life, when used against tumors that carry specific mutations.

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