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H. Jian



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    P3.04 - Clinical Design, Statistics and Clinical Trials (ID 720)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Clinical Design, Statistics and Clinical Trials
    • Presentations: 1
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      P3.04-005 - PD-L1 and Other Immuno-Markers Influenced by Osimertinib Treatment in Advanced Non-Small Cell Lung Cancer Patients (ATHENE Study) (ID 9749)

      09:30 - 09:30  |  Author(s): H. Jian

      • Abstract
      • Slides

      Background:
      This study will investigate whether PD-L1 and other immuno-markers will be influenced by osimertinib treatment in advanced EGFR T790M positive advanced NSCLC patients，who have progressed on an EGFR-TKI.

      Method:
      This study is an ASTRIS companion study. Major eligibility criteria include locally advanced (stage IIIB) or metastatic (stage IV) EGFR sensitive mutation NSCLC, not amenable to curative surgery or radiotherapy, with confirmation of the presence of the T790M mutation, prior therapy with an EGFR-TKI, PS 0-2, and the patients are willing to provide tumor specimens before osimertinib treatment and at the time of disease progression. The FFPE tissue samples will be collected at the time of baseline and disease progression. PD-L1 and CD8+ T cell will be detected by IHC (Ventana SP263). Immune-related gene will be detected by ThermoFisher Oncomine[TM] Immune Response Panel (398genes). The plasma samples will be collected at the time of baseline and disease progression, and tumor mutational burden will be detected by QIAGEN Mix-561-Match Panel (561 genes). A sample size of 62 will provide a power of 80% to detect the change at an alpha level of 0.05 based on Wilcoxon rank sum test. Assuming re-biopsy will be obtained from 40% patients at disease progression, the total number of patients will be 155. Estimated date of first subject enrollment will be before March 2017, and last subject last visit will be at June 2018. (NCT03029858)

      Result:
      The clinical trial is open for enrollment.

      Conclusion:
      The study points are not reached now.

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