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Scott Cowan

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    P3.17 - Treatment of Locoregional Disease - NSCLC (Not CME Accredited Session) (ID 983)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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      P3.17-22 - Nivolumab Plus Cisplatin/Pemetrexed or Cisplatin/Gemcitabine as Induction in Resectable NSCLC (ID 14429)

      12:00 - 13:30  |  Author(s): Scott Cowan

      • Abstract
      • Slides


      For patients (pts) with stage IB (>4cm)-IIIA Non-small-cell lung cancer (NSCLC), multi-modality therapy yields a modest improvement in 5 year post-surgical overall survival (OS), with comparable benefit for induction and postoperative adjuvant chemotherapy (chemo). Induction can speed the discovery of promising regimens by using pathologic response as a surrogate for OS. About 20% of pts treated with induction chemo have major pathologic response (MPR) (< 10% viable tumor) at primary and lymph nodes while pathologic complete responses (pCR) average 4%. MPR was strongly associated with improved OS (Hellmann MD, Lancet, 2014). PD-1 checkpoint inhibitors (CI), nivolumab (nivo), pembrolizumab (pembro), and the PD-L1 CI, atezolizumab, are established in advanced NSCLC as 2nd line therapy, and pembro is approved as a single agent as 1st line treatment of pts with PD-L1 high expressing tumors. In a phase III 1st line NSCLC study, pts with high mutational burden tumors had superior OS with nivo plus ipilimumab compared to doublet chemo. Pembro plus carboplatin with pemetrexed (P) was approved as 1st line therapy based on a randomized phase II study in advanced NSQ NSCLC showing improved clinical response and PFS compared to chemo alone with no increase in grade III toxicity. We therefore hypothesize that the addition of nivo to induction cisplatin (C) P or C gemcitabine (G) will increase the MPR rate over induction chemo alone compared to historical controls.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      This is an investigator initiated trial for pts with newly diagnosed clinical stage I-IIIA (stage I > 4cm) SQ and NSQ NSCLC. Induction is C 75mg/m2 IV q 3w x 3 plus either P 500 mg/m2 IV q 3wks x 3 or G 1250mg/m2 IV d1, d8 q 3 wks x 3 plus nivo 360mg IV q 3w x 3. Surgery is planned 3 wks after the last dose. The primary outcome is MPR. Secondary outcomes include safety, pCR, overall clinical response rate, clinical CR, 1 year PFS, OS and exploratory outcomes assessing markers of immune bias. Enrollment will be 34 pts. NCT03366766

      4c3880bb027f159e801041b1021e88e8 Result

      Section not applicable

      8eea62084ca7e541d918e823422bd82e Conclusion

      Section not applicable


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