Author of

• 15209

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  P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)

  • Event: WCLC 2015
  • Type: Poster
  • Track: Treatment of Advanced Diseases - NSCLC
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)

  • 15297

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    P3.01-088 - Phase IV Study of Afatinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (ID 1562)

    09:30 - 09:30  |  Author(s): R. Gaafar
    • Abstract

    Background:
    First-line afatinib, an oral, irreversible ErbB family blocker, improved progression-free survival (PFS), objective response rate and symptom control in patients with epidermal growth factor receptor (EGFR) mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC), when compared with standard platinum-doublet chemotherapy. Afatinib also significantly prolonged overall survival in patients with Del19 mutations. Some EGFR mutation-positive patients still receive first-line chemotherapy and there are limited data regarding the effect of afatinib in chemotherapy pre-treated EGFR mutation-positive patients. This study was designed to evaluate the efficacy and safety of 40 mg/day afatinib in the second-line setting.
    
    Methods:
    Across centers in Europe, Asia and North Africa, 60 patients with locally advanced or metastatic NSCLC (stage IIIB/IV) harboring common EGFR mutations (Del19 and/or L858R) who have failed first-line platinum-based chemotherapy will be recruited to this ongoing, single-arm, open-label, Phase IV trial. Patients will be treated with oral afatinib 40 mg/day until the development of progressive disease or study discontinuation due to intolerable adverse events (AEs). Inclusion criteria include age ≥18 years, ECOG PS 0 or 1, documented EGFR Del19 and/or L858R mutation with no other known EGFR mutation, and adequate organ function with a life expectancy of ≥3 months. Patients are excluded from enrolling if they have received >1 line of prior therapy for disease (radiotherapy and radiosensitizers and/or intrapleural administration of anti-cancer agents is not counted as a line of therapy), or received <3 cycles of platinum-based chemotherapy due to toxicity and/or intolerance of treatment, or received previous treatment with an EGFR-targeted tyrosine kinase inhibitor or antibody. The primary endpoint is objective tumor response (complete response [CR], partial response [PR]) according to RECIST v1.1. Secondary endpoints include PFS, disease control (CR, PR, stable disease) and assessment of safety. All patients who received at least one dose of afatinib will be included in the analysis of safety, with AEs graded according to CTCAE v3.0. Efficacy and safety will be evaluated in a descriptive manner; there are no formal statistical hypotheses. This trial was initiated in October 2014 and is open for accrual. Study locations include 22 trial sites in 7 countries. Trial sites are currently open to enrollment in Egypt, Romania, and Serbia. Enrollment will soon be open in Malaysia, the Philippines, Poland, and Thailand. The estimated completion date for the primary outcome is December 2016; further details are available at ClinicalTrials.gov (NCT02208843).
    
    Results:
    Not applicable.
    
    Conclusion:
    Not applicable.