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    Association details:
    Biomarker:EGFR L858R
    Cancer:Non Small Cell Lung Cancer
    Drug:nazartinib (EGF816) (EGFR inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC

    Excerpt:
    ...- Patients must have histologically or cytologically confirmed locally advanced (stage IIIB) or metastatic (stage IV) EGFR mutant (ex19del, L858R) NSCLC....
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Study of EGF816 and Gefitinib in TKI-naïve EGFR-mutant Non-Small Cell Lung Cancer

    Excerpt:
    ...Specifically, patients harboring the most common mutations, deletions in exon 19 or the L858R mutation in exon 21 are eligible....
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Phase III Study of Nazartinib (EGF816) Versus Erlotinib/Gefitinib in First-line Locally Advanced / Metastatic NSCLC With EGFR Activating Mutations

    Excerpt:
    ...- Histologically documented locally advanced or metastatic, stage IIIB/ IIIC or stage IV NSCLC with documented EGFR activating mutation (L858R or ex19del)...
    Trial ID:
    NCT03529084
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO 2020
    Title:

    Nazartinib (EGF816) in patients with treatment-naïve EGFR-mutant non-small cell lung cancer (NSCLC): Updated phase II results.

    Published date:
    05/13/2020
    Excerpt:
    Tx-naïve adult pts with activating EGFR-mut (L858R or ex19del), stage IIIB/IV adv NSCLC with neurologically stable and controlled brain metastasis (BM) received oral nazartinib 150 mg once daily...ORR by BIRC: 69%; median PFS by BIRC: 18 mo;median OS was NE and at 33 mo,56% of pts were alive...Nazartinib is a promising 3rd generation EGFR TKI for tx-naïve pts with adv EGFR-mut NSCLC, including pts with baseline BM.
    DOI:
    10.1200/JCO.2020.38.15_suppl.9574
    Trial ID:
    NCT02108964
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ESMO 2018
    Title:

    Phase II results for single-agent nazartinib (EGF816) in adult patients (pts) with treatment-naive EGFR-mutant non-small cell lung cancer (NSCLC)

    Published date:
    10/01/2018
    Excerpt:
    Treatment-naive pts with NSCLC harboring activating EGFR mutations (L858R and/or ex19del) received oral nazartinib 150 mg QD on a continuous schedule….Nazartinib demonstrated a tolerable safety profile and promising efficacy, with durable responses in treatment-naive pts with advanced EGFR-mutant NSCLC, including pts with baseline BM.
    DOI:
    10.1093/annonc/mdy424.073
    Trial ID:
    NCT02108964