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    Association details:
    Biomarker:EGFR exon 20 insertion
    Cancer:Non Small Cell Lung Cancer
    Drug:Erbitux (cetuximab) (EGFR inhibitor) +
    Gilotrif (afatinib) (EGFR inhibitor, HER2 inhibitor, HER4 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Go to data
    Source:
    clinicaltrials.gov
    Title:

    Afatinib and Cetuximab in Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Positive Non-small-cell Lung Cancer

    Excerpt:
    ...- Pathologically or cytologically confirmed stage IV non-small cell lung cancer, harboring an EGFR exon 20 insertion mutation....
    Trial ID:
    AFACET
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Cancer
    Title:

    A phase 2 trial combining afatinib with cetuximab in patients with EGFR exon 20 insertion-positive non-small cell lung cancer

    Published date:
    10/31/2023
    Excerpt:
    In this single-arm phase 2 trial, patients with advanced NSCLC harboring an EGFR ex20ins mutation were treated with afatinib 40 mg once daily in combination with cetuximab 500 mg/m2 every 2 weeks….The study achieved its primary end point with a DCR of 54% at 18 weeks, an overall response rate (ORR) of 43%, and a 32% confirmed ORR. Best responses were partial (n = 16), stable (n = 16), progressive disease (n = 2), or not evaluable (n = 3). Median progression-free survival was 5.5 months (95% CI, 3.7-8.3 months) and median overall survival was 16.8 months (95% CI, 10.7-25.8 months).
    DOI:
    10.1002/cncr.35090
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO 2021
    Title:

    Interim results of a phase II single arm trial combining afatinib with cetuximab in patients with EGFRex20ins positive NSCLC.

    Published date:
    05/19/2021
    Excerpt:
    In this Simon’s two stage, single-arm, phase II trial, patients with advanced NSCLC harboring an EGFRex20ins mutation were treated with afatinib 40 mg once daily, in combination with cetuximab...The primary endpoint was met as disease control was achieved by 10 patients (59%) after 18 weeks of treatment. Median PFS was 5.5 months. Best responses were partial (n = 8, RR 47%), stable (n = 7) or progressive disease (n = 2).
    DOI:
    10.1200/JCO.2021.39.15_suppl.9112
    Trial ID:
    AFACET
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    J Thorac Oncol
    Title:

    Afatinib and Cetuximab in Four Patients With EGFR Exon 20 Insertion-Positive Advanced NSCLC

    Excerpt:
    Dual EGFR blockade with afatinib and cetuximab may induce tumor responses in patients with EGFR exon 20 insertion-positive NSCLC.
    DOI:
    10.1016/j.jtho.2018.04.012