Author of

• 30601

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  P2.01 - Advanced NSCLC (ID 159)

  • Event: WCLC 2019
  • Type: Poster Viewing in the Exhibit Hall
  • Track: Advanced NSCLC
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall

  • 30621

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    P2.01-20 - Anlotinib vs. Docetaxel in Advanced Non-Squamous NSCLC (EGFR Wild-Type) After Progression on Platinum-Based Chemotherapy: A Trial Protocol (ID 1628)

    10:15 - 18:15  |  Presenting Author(s): Wenxiu Yao
    • Abstract

    Background
    

    Anlotinib, an oral VEGFR, FGFR, PDGFR and c-Kit tyrosine kinase inhibitor, showed significantly longer overall survival in a phase 3 trial. In the multi-center, open-label, randomized controlled ALTER-L023 trial, we compared anlotinib with docetaxel as second-line treatment in patients with advanced non-squamous EGFR wild-type non-small cell lung cancer (NSCLC) previously given platinum-based doublet chemotherapy.

    Method
    

    This multi-center, open-label, randomized controlled ALTER-L023 trial was conducted at 10 hospitals in China. Eligible patients with previously treated non-squamous EGFR wild-type NSCLC were randomly assigned (1:1) to receive anlotinib (12 mg QD from day 1 to 14 of a 21-day cycle) or docetaxel ( 75mg/m2, on day 1 of a 21-day cycle ) till progression or intolerable toxicity. The primary endpoint was progression-free survival (PFS), that was defined as the time from randomization to disease progression or death. The secondary endpoints included objective response rate, disease control rate, duration of response and safety. Based on a two-sided log-rank test at 5% significance level, a power of 80% and a median PFS of 6 months for anlotinib versus 3 months for docetaxel，the simple size was estimated at 77 patients. Allowing for 15% dropouts, the sample size was set at 88 patients (44 patients in both groups).

    Clinical trial information: NCT03703596

    Result
    

    Section not applicable

    Conclusion
    

    Section not applicable