Real-world ALK Testing Trends in Patients With Advanced Non–Small-Cell Lung Cancer in the United States

Published:October 12, 2022DOI:


      • Tumors from 73% of patients with advanced NSCLC were tested for ALK rearrangements in 2019.
      • Approximately 3 weeks passed between NSCLC diagnosis and ALK test result.
      • In 2019, FISH and NGS were used for 32% and 52% of ALK tests, respectively.
      • 25% of patients with ALK-positive NSCLC began systemic therapy before receiving ALK test result.



      Patients with non–small-cell lung cancer (NSCLC) whose tumors harbor anaplastic lymphoma kinase (ALK) rearrangements can be treated with ALK tyrosine kinase inhibitors. We assessed real-world ALK biomarker testing and treatment patterns of patients with NSCLC in the United States.

      Patients and Methods

      Data were extracted from the Flatiron Health electronic health record-derived deidentified database for patients aged ≥18 years with stage IIIB or IV NSCLC and ≥2 clinic visits between January 2011 and December 2019.


      Among 60,025 eligible patients, tumors from 36,691 (61.1%) patients were tested for ALK rearrangements, and 1042 (2.8%) tested positive (ALK+). From 2011 to 2019, ALK testing rates increased from 33.1% to 73.0%; testing via fluorescence in situ hybridization declined from 68.3% to 32.1% while next-generation sequencing increased from <1% to 52.2%. Although tissue samples were more commonly used than blood (85.1% vs. 13.5% of tests), blood sample testing increased from 0.1% in 2011 to 28.2% in 2019. Median (interquartile range) time from diagnosis of advanced NSCLC to first ALK+ test result was 23 (13-43) days, including laboratory processing time of 9 (6-14) days. For the 24.7% of patients with an ALK+ test result who began treatment before receiving the positive result, chemotherapy was initiated most often overall until 2018 when immuno-oncology agents became most common.


      Although ALK testing in NSCLC increased over time, testing rates among eligible patients did not reach 100% during the study period. Treatment decisions for some patients with NSCLC may have been made without important, guideline-recommended biomarker data.



      ALK (anaplastic lymphoma kinase), ALK (anaplastic lymphoma kinase gene), Chemo (chemotherapy), EGFR (epidermal growth factor receptor), EHR (electronic health record), FDA (Food and Drug Administration), FISH (fluorescence in situ hybridization), IHC (immunohistochemistry), IO (immuno-oncology), IQR (interquartile range), NCCN (National Comprehensive Cancer Network (NCCN)), NGS (next-generation sequencing), NOS (not otherwise specified), NSCLC (non–small-cell lung cancer), PCR (polymerase chain reaction), Pd-1 (programmed cell death-1), Pd-L1 (programmed death-ligand 1), RNA (ribonucleic acid), TKI (tyrosine kinase inhibitor), TPS (tumor proportion score), UNK (unknown), US (United States)
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