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Lawrence Einhorn



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    FP01 - Early Stage/Localized Disease (ID 111)

    • Event: WCLC 2020
    • Type: Posters (Featured)
    • Track: Early Stage/Localized Disease
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      FP01.04 - BTCRC LUN19-396:  Adjuvant Chemotherapy Plus Atezolizumab in Stage IB-IIIA Resected NSCLC and Clearance of ctDNA (ID 3164)

      00:00 - 00:00  |  Author(s): Lawrence Einhorn

      • Abstract

      Introduction

      The vast majority of patients with stage IB - IIIA NSCLC are managed with upfront surgery, followed by 4 cycles of empiric adjuvant chemotherapy. However, many patients are cured with surgery alone and do not need any adjuvant therapy. While some patients require adjuvant therapy to achieve cure, the amount of adjuvant therapy necessary to achieve this goal is unknown. In order to optimize treatment, a predictive biomarker is needed to evaluate which patients benefit from adjuvant therapy and to personalize duration of treatment. Emerging data has evaluated the use of circulating tumor DNA (ctDNA) as a promising biomarker for early detection of minimal residual disease to predict risk of relapse. BTCRC LUN19-396 is a multicenter, phase II trial that aims to evaluate the role of concomitant chemotherapy and checkpoint inhibitor in the adjuvant setting for stage IB-IIIA resected NSCLC, and the clearance of ctDNA as a surrogate biomarker for long term disease free survival.

      Methods

      All patients with stage IB (tumors > 4cm), IIA, IIB, and select IIIA (T3N1, T4N0-1) resected NSCLC will be screened for study entry and will have ctDNA assessed within 60 days after surgery. All patients (regardless of whether they have detectable ctDNA after surgery) will be enrolled and treated with 4 cycles of cisplatin based chemotherapy plus concomitant atezolizumab, followed by up to 13 additional cycles of atezolizumab alone. Sequential analysis of ctDNA will be performed in all patients every 3 months until the end of treatment, up to 17 cycles at 13 months. The trial will enroll a total of 100 patients. The primary objective is to estimate the percentage of patients with detectable ctDNA after surgery who have clearance of ctDNA at designated time points during adjuvant therapy. The key secondary objective is to estimate the 1-year disease free survival in patients with undetectable ctDNA after 4 cycles of adjuvant chemotherapy plus atezolizumab who had detectable ctDNA after surgery. This trial opened to accrual in May 2020. Clinical trial information: NCT04367311

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