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Yaser Homsi



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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
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      P2.01-14 - Phase 3 Trial of Sitravatinib Plus Nivolumab vs Docetaxel for Treatment of NSCLC After Platinum-Based Chemoimmunotherapy (ID 614)

      10:15 - 18:15  |  Author(s): Yaser Homsi

      • Abstract

      Background

      Sitravatinib is a tyrosine kinase inhibitor (TKI) that targets multiple closely-related receptor tyrosine kinases (RTKs), including the split RTKs VEGFR-2 and KIT as well as the TAM (TYRO3, AXL, and MER) RTKs. Inhibition of the split RTKs may reduce immunosuppressive regulatory T (Treg) cells and myeloid‑derived suppressor cells (MDSCs) within the tumor microenvironment (TME), while inhibition of TAM RTKs may, in addition to promoting depletion of MDSCs, repolarize tumor associated macrophages towards the M1 phenotype that is associated with secretion of pro-inflammatory cytokines. Given these pleiotropic immune‑stimulating effects, sitravatinib may augment the antitumor immune response of nivolumab in patients (pts) with non-small cell lung cancer (NSCLC). An ongoing Phase 2 study demonstrates clinical activity of this combination in pts with metastatic non-squamous NSCLC after progression on a checkpoint inhibitor (CIT).

      Method

      This randomized, open-label, Phase 3 study (N=664) compares the efficacy and safety of sitravatinib in combination with nivolumab vs docetaxel in pts with advanced non-squamous NSCLC who have radiographically documented disease progression on or after platinum-based chemotherapy in combination with CIT. Pts are randomized (1:1) to receive sitravatinib administered orally once daily in continuous 28-day cycles at 120 mg combined with nivolumab IV at 240 mg every 2 weeks or 480 mg every 4 weeks vs treatment with docetaxel 75 mg/m2 IV every 3 weeks. Patients will be stratified based on duration of previous CIT treatment, ECOG performance status, and presence of brain metastases at baseline. Key eligibility criteria include duration of treatment of CIT for at least 4 months, discontinuation of prior treatment with CIT < 90 days prior to the date of randomization, and absence of symptomatic or uncontrolled brain metastases. The primary endpoint is Overall Survival (OS). Key secondary endpoints include safety and tolerability, ORR, PFS, PROs, and PK. OS will be analyzed using Kaplan-Meier methods and the stratified log-rank test to estimate and compare the median OS between the two treatment arms with 95% CI. An IDMC will be established to review safety at regular intervals and to review efficacy data at the planned interim analysis for futility and possible sample size adjustment based on OS.

      Recruitment begins May 2019.

      NCT number NCT03906071

      Result

      Section not applicable

      Conclusion

      Section not applicable.