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    Association details:
    Biomarker:EGFR L858R
    Cancer:Lung Adenocarcinoma
    Drug:Gilotrif (afatinib) (EGFR inhibitor, HER2 inhibitor, HER4 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    J Clin Oncol
    Title:

    Phase III Study of Afatinib or Cisplatin Plus Pemetrexed in Patients With Metastatic Lung Adenocarcinoma With EGFR Mutations

    Published date:
    07/01/2013
    Excerpt:
    Afatinib is associated with prolongation of PFS when compared with standard doublet chemotherapy in patients with advanced lung adenocarcinoma and EGFR mutations.
    Secondary therapy:
    pemetrexed
    Evidence Level:
    Sensitive: C1 - Off-label
      (Approved for Non Small Cell Lung Cancer)
    New
    Excerpt:
    GILOTRIF is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    LUX-Lung 7: A Phase IIb Trial of Afatinib(BIBW2992) Versus Gefitinib for the Treatment of 1st Line EGFR Mutation Positive Adenocarcinoma of the Lung

    Excerpt:
    ...Documented activating epidermal growth factor receptor mutation (Del19 and/or L858R) with tumour tissues....
    Trial ID:
    LUX-Lung 7
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Efficacy and Safety Study of Afatinib to Treat Lung Cancer Patients

    Excerpt:
    ...L858R, exon 19 deletions, exon 20 insertions, T790M, list is...
    Trial ID:
    NCT01415011
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Afatinib as Second-line Therapy for Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation

    Excerpt:
    ...Documented EGFR mutation (L858R and/or Deletion 19) with...
    Trial ID:
    NCT02208843
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    BI 1361849 (CV9202) + afatinib compared with placebo + afatinib in first-line NSCLC harbouring common EGFR mutations BI 1361849 (CV9202) + afatinib comparado con placebo + afatinib como tratamiento de primera línea en pacientes con NSCLC portadores de mutaciones comunes del EGFR.

    Excerpt:
    ...Documented activating EGFR mutation (Del 19 and/or L858R) determined in tumour tissues ? ...
    Trial ID:
    2015-001477-41
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Observational Study of Afatinib 30 mg Daily

    Excerpt:
    ...Documented EGFR mutation(s)-positive NSCLC (common mutations: Del19 and L858R) from tumour biopsy material....
    Trial ID:
    NCT04909073
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    J Thorac Dis
    Title:

    Afatinib 30 mg in the treatment of common and uncommon EGFR-mutated advanced lung adenocarcinomas: a retrospective, single-center, longitudinal study

    Published date:
    06/09/2022
    Excerpt:
    EGFR-mutated advanced LAD patients receiving afatinib (30 mg/d) from January 2017 to November 2021 were retrospectively included. EGFR status was classified into three subtypes, namely common mutations including exon 19 deletions (19del) and exon 21 L858R (21L858R), uncommon mutations including G719X, L861Q, S768I....In the first-line setting, patients with common and uncommon mutations had a significantly longer PFS compared to those with 20ins [14.53 (13.53-15.53) vs. 10.39 (4.87-15.91) vs. 2.37 (0.00-5.11) months, P<0.001]....Afatinib at 30 mg/d is associated with a favorable efficacy and tolerability in the treatment of advanced LAD with common and major uncommon EGFR mutations except 20ins.
    DOI:
    10.21037/jtd-22-507