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    Association details:
    Biomarker:HER-2 amplification
    Cancer:Non Small Cell Lung Cancer
    Drug:Irene (pyrotinib) (EGFR inhibitor, HER2 inhibitor, HER4 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Phase II Clinical Study of Pyrotinib in First-line Treatment of Primary HER2-amplified/Mutated Advanced Non-small Cell Lung Cancer

    Excerpt:
    ...HER2 insertion mutation, primary HER2 point mutation or primary HER2 amplification confirmed by genetic testing of tumor tissue or blood, pleural effusion, cerebrospinal fluid and other specimens; 5....
    Trial ID:
    NCT05751018
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Real-World Study of Pyrotinib Maleate in the Treatment of Advanced/Metastatic Non-Small Cell Lung Cancer With Rare Mutations in HER2

    Excerpt:
    ...HER2 mutation and amplification confirmed by gene testing of tumor tissue or blood, pleural effusion, cerebrospinal fluid and other specimens;...
    Trial ID:
    NCT05411276
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Phase I Study of Pyrotinib in Patients With HER2-positive Solid Tumors

    Excerpt:
    ...- have confirmed HER2 gene amplified tumor fluorescence in-situ hybridization (FISH, HER2/cep17 ratio > 2) or HER2 overexpression (IHC 3+) or documented HER2 gene mutation....
    Trial ID:
    NCT02500199
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Pyrotinib Combined With Pemetrexed Plus Carboplatin in the First-line Treatment

    Excerpt:
    ......
    Trial ID:
    NCT04706949
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Clin Cancer Res
    Title:

    Pyrotinib in Patients with HER2-Amplified Advanced Non-Small Cell Lung Cancer: A Prospective, Multicenter, Single-Arm Trial

    Published date:
    11/09/2021
    Excerpt:
    In this prospective, multicenter, single-arm trial (ChiCTR1800020262), advanced NSCLC patients with HER2 amplification, as determined by next-generation sequencing, were enrolled and administered pyrotinib orally at 400 mg per day….Patients administered pyrotinib as first-line treatment achieved an mPFS of 12.4 months....Pyrotinib provided antitumor efficacy with a manageable safety profile in HER2-amplified NSCLC patients.
    DOI:
    10.1158/1078-0432.CCR-21-2936
    Evidence Level:
    Sensitive: C4 – Case Studies
    Source:
    Anticancer Drugs
    Title:

    Pyrotinib for HER2-amplified non-small cell lung cancer patient after progression to Afatinib: a case report

    Published date:
    03/23/2022
    Excerpt:
    In this report, a nonsmoker, Chinese, old, male patient was diagnosed with cT2bN3M0 non small cell lung cancer with genetic testing revealing HER2 amplification….Then the treatment regimen was switched to pan-HER inhibitor pyrotinib 400 mg daily, with which the patient remained with stable disease for 9 months.
    DOI:
    10.1097/CAD.0000000000001298