Essential Information on Lung Cancer Biomarker Testing and Prognosis | Healthcare Professionals

Various international and national expert guidelines on biomarker testing in lung cancer recommend the majority of patients with lung
cancer should be tested. Depending on the patient’s disease stage at diagnosis, testing may include detecting:^1–11

Early* lung cancer: (Stage I–III) NSCLC:

EGFR gene mutations

ALK gene fusions

PD-L1 protein expression

*Per NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®), testing in early-stage NSCLC is recommended for Stages IB–IIIA, IIIB (T3,N2)

Advanced/metastatic (Stage IV) NSCLC

EGFR gene mutations
ALK gene fusions
ROS1 gene rearrangements
BRAF gene mutations
KRAS G12C mutations

MET exon 14 skipping mutations
RET gene rearrangements
HER2 mutations
NTRK1/2/3 gene fusions
PD-L1 protein expression

Approximately 60% of NSCLC tumours have an actionable driver oncogene mutation that is associated with an approved targeted therapy.^12–14
Furthermore, around 50–68% of NSCLC tumours have PD-L1 expression above clinically meaningful cut-offs.^15–18

Biomarker Testing

The biomarkers listed above, including what they are and how they are tested, are discussed in more detail in the Biomarker Testing in Lung Cancer page.

Technical Considerations

Performing robust, reliable, high-quality biomarker testing is key to making informed treatment decisions for patients. Further details on the technical considerations of biomarker testing in NSCLC can be found here.

FIGURE: Molecular landscape of NSCLC: prevalence of oncogenic driver mutations in NSCLC¹⁹

Molecular landscape of NSCLC – Pie Chart

ABBREVIATIONS:
ALK, anaplastic lymphoma kinase; BRAF, B-Raf proto-oncogene; EGFR, epidermal growth factor receptor; HER2, human epidermal growth factor receptor 2; KRAS, Kirsten rat sarcoma virus; MET, MET proto-oncogene, receptor tyrosine kinase; NRG1, neuregulin 1; NSCLC, non-small cell lung cancer; NTRK, neurotrophic receptor tyrosine kinase; RET, rearranged during transfection; ROS1, ROS proto-oncogene 1

ABBREVIATIONS:
ALK, anaplastic lymphoma kinase; BRAF, B-Raf proto-oncogene; EGFR, epidermal growth factor receptor; HER2, human epidermal growth factor receptor 2; KRAS, Kirsten rat sarcoma virus; MET, MET proto-oncogene, receptor tyrosine kinase; NCCN, National Comprehensive Cancer Network; NSCLC, non-small cell lung cancer; NTRK1/2/3, neurotrophic receptor tyrosine kinase 1/2/3; PD-L1, programmed cell death ligand-1; RET, rearranged during transfection; ROS1, ROS proto-oncogene 1

REFERENCES:

Lindeman NI, et al. Updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted tyrosine kinase inhibitors: guideline from the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. Arch Pathol Lab Med 2018;142:321–46.
Remon J, et al. Early and locally advanced non-small-cell lung cancer: an update of the ESMO Clinical Practice Guidelines focusing on diagnosis, staging, systemic and local therapy. Ann Oncol 2021;32:1637–42.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Non-Small Cell Lung Cancer V.11.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed October 28, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
Hendriks LE, et al. Non-oncogene-addicted metastatic non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol 2023;34:358–76.
Hendriks LE, et al. Oncogene-addicted metastatic non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol 2023;34:339–57.
Singh N, et al. Therapy for Stage IV Non–Small-Cell Lung Cancer With Driver Alterations: ASCO Living Guideline. J Clin Oncol 2022;40:3310–22.
Singh N, et al. Therapy for Stage IV Non–Small-Cell Lung Cancer Without Driver Alterations: ASCO Living Guideline. J Clin Oncol 2022;40:3323–43.
Isla D, et al. New update to the guidelines on testing predictive biomarkers in non-small-cell lung cancer: a National Consensus of the Spanish Society of Pathology and the Spanish Society of Medical Oncology. Clin Transl Oncol 2023;25:1252–67.
Kalemkerian GP, et al. Molecular Testing Guideline for the Selection of Patients With Lung Cancer for Treatment With Targeted Tyrosine Kinase Inhibitors: American Society of Clinical Oncology Endorsement of the College of American Pathologists/International Association for the Study of Lung Cancer/Association for Molecular Pathology Clinical Practice Guideline Update. J Clin Oncol 2018;36:911–19.

Pisters K, et al. Adjuvant Systemic Therapy and Adjuvant Radiation Therapy for Stage I-IIIA Completely Resected Non–Small-Cell Lung Cancer: ASCO Guideline Rapid Recommendation Update. J Clin Oncol 2022;40:1127–29.
Pennell NA, et al. Biomarker testing for patients with advanced non-small cell lung cancer: real-world issues and tough choices. Am Soc Clin Oncol Educ Book 2019;39:531–542.
Kris MG, et al. Using Multiplexed Assays of Oncogenic Drivers in Lung Cancers to Select Targeted Drugs. JAMA 2014;311:1998–2006.
Barlesi F. et al., Routine molecular profiling of patients with advanced non-small-cell lung cancer: results of a 1-year nationwide programme of the French Cooperative Thoracic Intergroup (IFCT). Lancet 2016;387:1415–26.
Li F, et al. Prevalence of targeted therapy-related genetic variations in NSCLC and their relationship with clinicopathological characteristics. PLoS ONE 2022;17:e0262822.
Aggarwal C, et al. Prevalence of PD-L1 expression in patients with non-small cell lung cancer screened for enrollment in KEYNOTE-001, -010, and -024. Ann Oncol 2016;27(Suppl. 6):vi359–78.
Forde P.M, et al. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med 2022;386:1973–85.
Heymach JV, et al. AEGEAN: A phase 3 trial of neoadjuvant durvalumab + chemotherapy followed by adjuvant durvalumab in patients with resectable NSCLC. Cancer Res 2023;83(Suppl. 8):CT005 (abstr).
Wakelee HA, et al. KEYNOTE-671: Randomized, double-blind, phase 3 study of pembrolizumab or placebo plus platinum-based chemotherapy followed by resection and pembrolizumab or placebo for early stage NSCLC. J Clin Oncol, 2023;41(Suppl. 17):LBA100 (abstr).
Chevallier M, et al. Oncogenic driver mutations in non-small cell lung cancer: Past, present and future. World J Clin Oncol 2021;12:217–37.

Welcome to iD Lung

An online resource providing information on
biomarker testing for patients with lung cancer

Early* lung cancer: (Stage I–III) NSCLC:

Advanced/metastatic (Stage IV) NSCLC

Biomarker Testing

Technical Considerations

REFERENCES:

iD.Lung.com

Welcome to iD Lung

An online resource providing information on biomarker testing for patients with lung cancer

Early* lung cancer: (Stage I–III) NSCLC:

Advanced/metastatic (Stage IV) NSCLC

Biomarker Testing

Technical Considerations

REFERENCES:

iD.Lung.com

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An online resource providing information on
biomarker testing for patients with lung cancer