CGI’s Central Role in this Ground-Breaking 8,000 Patient Lung Cancer Trial

Written by: Anna Israyelyan, MD, PhD
Manager, Biopharma Solutions

Published on:
December 21st, 2017

Anna Israyelyan, MD, PhD
Dr. Israyelyan joined CGI in 2015. She has over 15 years of extensive cancer research and management experience in industry and academia covering wide range of medical areas, including basic, translational, and clinical research. Anna is an active member of the American Society of Hematology (ASH), the American Association for Cancer Research (AACR), and American Association for the Advancement of Science (AAAS). Dr. Israyelyan has a scientific advisory role with matrix management of scientific, technical, and operational aspects related to various biopharma projects and collaborations involving biomarkers in solid tumors and hematologic malignancies.

Launched in 2014, with sponsorship by the National Cancer Institute (NCI), the ALCHEMIST Lung Cancer Trials are at the leading edge of personalized medicine research…

The Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials, or ALCHEMIST, are a group of randomized clinical trials for patients with early-stage NSCLC. The trials represent three multi-center, randomized, integrated, precision medicine trials for patients with early stage NSCLC.  Unrivaled in size, it aims to systematically and definitively answer whether patients benefit from personalized medicine testing to determine eligibility for targeted therapy or immuno-oncology drugs after surgery.

Specifically, the trial design evaluate whether integrating targeted therapies based on molecular attributes of tumors will help prevent disease recurrence and improve overall survival.  The trial evaluates specific drugs targeted against EGFR and ALK genetic alterations and PD-L1 expression (erlotinib, crizotinib, and nivolumab, respectively).

Our laboratory in Los Angeles is now in its third year as the central lab to performing all EGFR mutations, ALK rearrangements, and PD-L1 testing.  We’re honored to serve this role for this cutting-edge trial and consider it one of our proudest achievements. 

The ALCHEMIST Trials

Our role in the ALCHEMIST trial exemplifies our technology-agnostic, multi-platform approach to patient testing and clinical trial support.  CGI has an extensive heritage in biomarker and molecular profiling for lung cancer.

We believe very few, if any, other labs offer such comprehensive offerings.  Our Lung Complete™ includes FDA-approved mutation tests, the first FDA-approved NGS test, all clinically-indicated PD-L1 IHC tests, as well as CLIA-validated liquid biopsy test.

Beyond ALCHEMIST, CGI supports dozens of industry-leading lung cancer trials and helps guide treatment decisions for hundreds of patients per month.  We continue to rely on a broad portfolio of tests and technologies, industry-leading quality and timely data delivery, and collaborations with biopharma and key opinion leaders to drive our success.

Email me today to learn more about how our comprehensive approach to lung cancer and extensive experience in custom assay development and validation to fit-for-purpose regulatory standards (NYS, CAP/CLIA, RUO, etc) could be used to meet your clinical trial and drug development needs.

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