NIH launches cohesive precision medicine trials for lung cancer

The NIH recently announced the launch of three integrated precision medicine trials to pinpoint early-stage lung cancer patients with tumors that harbor rare genetic changes and determine whether targeted treatments could improve survival.

The Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials, or ALCHEMIST, is supported by the National Cancer Institute, with the component trials coordinated by 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 as well regarding the genetic changes in the tumor at the time of recurrence,” Shakun Malik, MD, head of Thoracic Cancer Therapeutics in the Clinical Investigations Branch of NCI, said in a press release. “The findings will help to define clinical, biologic and molecular behaviors of this type of lung cancer.”

The three component trials of ALCHEMIST include:

ALCHEMIST - Screening component (A151216) – Coordinated by the Alliance for Clinical Trials in Oncology
ALCHEMIST - EGFR Treatment component (A081105) – Coordinated by the Alliance for Clinical Trials in Oncology
ALCHEMIST - ALK Treatment component (E4512) – Coordinated by ECOG-ACRIN

In the initial screening trial, 6,000 to 8,000 potential participants will be screened at hundreds of sites across the US over five to six years to detect those with EGFR and ALK alterations who would be eligible for the ensuing two treatment trials, anticipated to include 800 patients. All screened participants, regardless of their tumor marker status, will be followed for five years in the screening trial.

All participants in ALCHEMIST will continue to receive the best care possible for their lung cancer. At the end of the treatment trials, researchers will evaluate the survival of patients who received an additional genetically-targeted drug therapy vs. patients who received standard therapy alone.

“This approach highlights the ability of NCTN to efficiently screen large numbers of patients in order to identify those with early-stage EGFR mutant or ALK rearranged lung cancer,” Monica Bertagnolli, MD, from the Dana-Farber Cancer Institute and head of the Alliance for Clinical Trials in Oncology, said in the release. “Without this capability, it would be impossible to identify a sufficient number of patients needed to perform clinical trials to determine whether EGFR or ALK inhibitors prolong survival in early-stage lung cancer.”