Author of

• 30601

  +

  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

  • 30610

    +

    P2.01-09 - VinMetAtezo: Phase II Trial of Metronomic Oral Vinorelbine with Atezolizumab for Recurrent Stage IV NSCLC (GFPC*04-08) (ID 690)

    10:15 - 18:15  |  Author(s): Charles Ricordel
    • Abstract
    • Slides

    Background
    

    Immunotherapy is recommended as second-line treatment for advanced Non-Small Cell Lung Cancer (NSCLC) progressing after a platinum doublet treatment. However, response rates remain low and some patients have rapid progression. Novel concepts of synergic action between immunotherapy and chemotherapy have emerged recently. Metronomic oral vinorelbine (MOV) is defined as low-dose and frequent chemotherapy administration. There is no data of the association of immunotherapy and metronomic chemotherapy. The main objective of this trial was to assess safety and efficacy of this combination of MVO and atezolizumab.

    Method
    

    An open label phase 2 trial (NCT 03801304) in two steps.

    -First step: a safety run-in phase: 12 patients will be enrolled and will receive atezolizumab in combination with MOV (40 mg/day 3 times a week, every week). After 12 patients have received study treatment and completed at least 1 cycle of study treatment (21 days), enrollment will be interrupted and an independent Data Safety Monitoring Board (DSMB) will review the number and percentage of adverse events (AEs). The dose will be considered toxic when Grade ≥ 3 immune-related AEs (>20%) or vinorelbine-related AEs (>20%) occurs. In this case the dose will be decreased to 30 mg, 3 times a week. AEs will be assessed with the same procedure that will be applied to the next 12 patients.

    - Second step: phase II design as defined by A’hern. The main outcome is PFS rate at 4 months. Minimal efficacy hypothesis (p1) is set at 55% event-free rate of PFS at 4 months, (p0), which would indicate that the strategy is clearly ineffective, is set at 40% PFS at 4 months. With a 5% alpha risk (unilateral perspective) and a 20% beta risk, the number of assessable subjects is set at 71.

    Result
    

    The trial started on 2019 January 24^th. 12 patients have been included in 4 centers. The run in step ended at the beginning of April, with no grade 3 or more immune related AEs or vinorelbine related AEs. The DSMB decided to expand the study to the second step, which will start on April, 17^th.

    Conclusion
    

    Combination of atezolizumab and MOV appears as a feasible association without major toxicities. The phase 2 is ongoing; complementary results on safety and efficacy will be presented at the meeting.

    Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.