Author of

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  P2.12 - Small Cell Lung Cancer/NET (Not CME Accredited Session) (ID 961)

  • Event: WCLC 2018
  • Type: Poster Viewing in the Exhibit Hall
  • Track:
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall

  • 27153

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    P2.12-02 - Phase II Study of Combination of Nab-Paclitaxel and Gemcitabine for Relapsed Small Cell Lung Cancer (SCLC) (ID 13912)

    16:45 - 18:00  |  Author(s): Tajer Abu-Hejleh
    • Abstract

    Background
    

    Background: Almost all patients with extensive stage and two-thirds of limited stage small cell lung cancer develop disease recurrence or relapse after initial therapy. Most of these patients receive Topotecan as their subsequent therapy, which across multiple studies have shown response rates of approximately 15%. Though some of the newer agents have shown promising efficacy in biomarker selected patient-population;populations, ,in non-selected patients with relapsed SCLC, however, response rates with Nivolumab, Nivolumab in combination with Ipilimumab and Rovalpituzumab were only 10%, 23% and 18%, respectively. Among the conventional chemotherapies, both Gemcitabine and Paclitaxel have shown single agent activity in relapsed-refractory SCLC. Therefore, we hypothesized that combination of Gemcitabine and Nab-Paclitaxel will have additive effect, which will lead to improvement in therapeutic response compared to current standard of care. Based on the toxicity profile of this regimen in patients with advanced pancreatic cancer, we believe it will be better tolerated than Topotecan.

    a9ded1e5ce5d75814730bb4caaf49419 Method
    

    Methods: This is a single-arm phase II study. Primary end-point of the study is response rate as defined per RECIST 1.1 criteria. Eligible subjects will receive gemcitabine 1000 mg/m² and nab-paclitaxel 100 mg/m² on days 1 & 8 of every 21-day cycle. Response assessment will occur every 6 weeks. Target accrual is 32 with 28 evaluable subjects. This would achieve 82% power to detect a difference of 20% to current standard of care therapy, using a one-sided binomial exact test. The results assume that the current standard of care (Topotecan) has a response rate of 15%. Secondary end-points include overall survival, time to progression and treatment-related toxicity

    4c3880bb027f159e801041b1021e88e8 Result
    

    Section not applicable

    8eea62084ca7e541d918e823422bd82e Conclusion
    

    Section not applicable

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