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)

  • 15290

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    P3.01-081 - Navotrial 3: Oral Vinorelbine + Cisplatin (P) vs Gemcitabine + P in 1st Line Advanced Squamous Non-Small-Cell Lung Cancer (ID 1210)

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

    Background:
    Gemcitabine – cisplatin is one of the most frequent treatment used in patients with advanced S-NSCLC without any direct comparison with other active doublets and with superiority reported only versus pemetrexed-cisplatin (Scagliotti G., 2008). Oral vinorelbine-cisplatin is also one main standard doublet but no trial has been specifically conducted in S-NSCLC. The aim of the current study is to assess efficacy and safety of oral vinorelbine-cisplatin and gemcitabine-cisplatin in S-NSCLC patients (NAVoTRIAL 3).
    
    Methods:
    This is a phase II, international multicentre, randomised study (1:1). At baseline, patients must have stage IIIB or IV, squamous histologically or cytologically proven NSCLC, Karnofsky PS ≥70 and must not have received prior systemic CT or immunotherapy for NSCLC.Patients in arm A will receive oral vinorelbine at the dose of 60 mg/m² in combination with cisplatin at the dose of 80 mg/m² on day 1, followed by oral vinorelbine, 60 mg/m² on day 8 at the first cycle; the dose is increased at the second cycle to 80 mg/m² in absence of haematological tolerance. Both agents are repeated every 3 weeks, followed by maintenance after four cycles for patients with OR/SD: oral vinorelbine at the same dose as cycle 4, day 1, 8 every 3 weeks.Patients in arm B will receive gemcitabine at the dose of 1250 mg/m² in combination with cisplatin 75 mg/m² on day 1, followed by gemcitabine, 1250 mg/m² on day 8. Both agents are repeated every 3 weeks, followed by maintenance after four cycles for patients with OR/SD : Gemcitabine at the same dose as cycle 4, day 1, 8 every 3 weeks. The primary endpoint is the disease control rate (NC, CR, PR, RECIST 1.1). Enrolment began in March 2013 and 110 patients will be recruited.
    
    Results:
    Not applicable
    
    Conclusion:
    Not applicable