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Shawn W. Sun



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    P2.17 - Treatment of Locoregional Disease - NSCLC (Not CME Accredited Session) (ID 966)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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      P2.17-27 - IMpower030: Phase III Study Evaluating Neoadjuvant Treatment of Resectable Stage II-IIIB NSCLC with Atezolizumab + Chemotherapy (ID 12087)

      16:45 - 18:00  |  Author(s): Shawn W. Sun

      • Abstract
      • Slides

      Background

      A standard of care for resectable early-stage non-small cell lung cancer (NSCLC) is surgery alone or in combination with adjuvant or neoadjuvant platinum-based doublet chemotherapy (PT-DC). Nevertheless, 30%-70% of patients develop recurrence and die due to disease progression, highlighting the unmet need for more efficacious treatment regimens. Atezolizumab, an anti–programmed death-ligand 1 (anti–PD-L1) antibody that reinvigorates the anti-cancer immune response, has shown efficacy as monotherapy and in combination with chemotherapy in advanced NSCLC. On the basis of this activity, it is thought that the combination of atezolizumab and PT-DC may provide clinical benefit in the neoadjuvant setting by enhancing cancer cell killing and eradicating micro-metastases prior to surgery, thereby reducing the risk of disease recurrence. The objective of IMpower030 (NCT03456063) is to evaluate the efficacy and safety of atezolizumab in combination with PT-DC as neoadjuvant treatment for patients with resectable early-stage NSCLC.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      IMpower030 is a global, Phase III, multicenter, double-blind, randomized study in patients with histologically or cytologically confirmed, resectable stage II, IIIA, or select IIIB (T3N2) NSCLC (per AJCC/UICC, 8th ed). Study inclusion requires measurable disease per RECIST v1.1, ECOG PS of 0/1, and eligibility for R0 resection with curative intent and PT-DC. Patients who have received prior therapy for lung cancer or who present with non-squamous NSCLC with activating EGFR mutations or ALK translocation are excluded. Approximately 302 patients will be randomized to receive 4 cycles of neoadjuvant atezolizumab (1200 mg Q3W, Arm A) or placebo (Arm B) in combination with an investigator-selected PT-DC regimen. Following surgical resection and pathology response assessment, treatment assignment will be unblinded; patients in Arm A will receive adjuvant treatment with atezolizumab for up to 16 cycles or until disease recurrence or unacceptable toxicity, whereas patients in Arm B will receive best supportive care and scheduled observational follow-up. The primary efficacy endpoint is major pathological response, defined as ≤ 10% residual viable tumor tissue at time of resection as assessed by an independent central pathology laboratory. Secondary efficacy endpoints include OS, ORR, investigator-assessed event-free survival and disease-free survival per RECIST v1.1, pathological complete response and patient-reported outcomes. Exploratory biomarkers will also be evaluated.

      4c3880bb027f159e801041b1021e88e8 Result

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      8eea62084ca7e541d918e823422bd82e Conclusion

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