Author of

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  P2.06 - Poster Session with Presenters Present (ID 467)

  • Event: WCLC 2016
  • Type: Poster Presenters Present
  • Track: Scientific Co-Operation/Research Groups (Clinical Trials in Progress should be submitted in this category)
  • Presentations: 1
  • Moderators:
  • Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)

  • 17855

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    P2.06-013 - Afatinib in Patients with Advanced HER2 Mutation-Positive (M+) NSCLC Previously Treated with Chemotherapy (ID 5154)

    14:30 - 14:30  |  Author(s): A. Cseh
    • Abstract
    • Slides

    Background:
    Afatinib, an irreversible ErbB family blocker, inhibits signalling from all homo- and hetero-dimers of ErbB family members (EGFR [ErbB1], HER2 [ErbB2], ErbB3 and ErbB4). Based on the results of two large Phase III trials (LUX-Lung 3 [LL3] and LL6), afatinib is approved in many countries for first-line treatment of patients with advanced EGFRm+ NSCLC. More recently, following results of the Phase III LL8 trial, afatinib was also approved for treatment of squamous cell carcinoma of the lung after platinum-based chemotherapy. Overexpression/amplification of HER2 has been identified in NSCLC and may have a role in acquired resistance to reversible EGFR tyrosine kinase inhibitors. Afatinib has demonstrated preclinical activity in HER2m+ lung cancer models and clinical activity in HER2m+ NSCLC patients (de Greve et al. Lung Cancer 2012; Mazieres et al. Ann Oncol 2015). This Phase II trial investigates the efficacy and safety of afatinib in patients with advanced NSCLC harbouring HER2 mutations, previously treated with chemotherapy (NCT02597946).
    
    Methods:
    In this Phase II, open-label, single-arm trial, eligible patients are aged ≥18 years, with ECOG PS 0/1, histologically or cytologically confirmed stage IV NSCLC, confirmed HER2m+ tumour tissue, and measurable disease (RECIST v1.1), following failure of one or two prior chemotherapy regimens, of which one is platinum-based. Prior radiotherapy (except palliative treatment), chemotherapy or immunotherapy within 4 weeks, hormonal therapy within 2 weeks, or EGFR/HER2-targeted therapy is not allowed. In Part A of this two-part trial, patients will receive continuous oral afatinib monotherapy at the approved starting dose of 40 mg/day. The dose may be escalated to 50 mg/day after 4 weeks in patients with minimal drug-related adverse events (AEs); dose reduction by 10-mg decrements to a minimum of 20 mg/day will occur in case of drug-related grade ≥3 or selected grade 2 AEs. In Part B, patients with ECOG PS ≤2 experiencing >12 weeks of clinical benefit with afatinib monotherapy before disease progression will continue treatment with afatinib plus weekly intravenous paclitaxel 80 mg/m[2]. In Parts A and B, treatment will continue until disease progression or intolerable AEs. The primary endpoint is objective response in Part A. Secondary endpoints include: disease control, progression-free survival, time to progression, and duration of response in Part A; and overall survival. Safety will also be assessed. Target enrolment is 40 patients, and participating countries will be listed in the full presentation.
    
    Results:
    Section not applicable.
    
    Conclusion:
    Section not applicable.
    
    

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