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- W4308385285 abstract "<h3>Background</h3> Immunotherapy +/- chemotherapy is currently the standard of care for metastatic NSCLC, but strategies to expand the benefit are still needed. Oligometastatic NSCLC is a state of limited disease in which widespread metastasis has not yet evolved. Locally radiotherapy achieves prolonged progression- free survival and overall survival in a small proportion of well selected oligometastatic NSCLC patients<sup>1</sup>. Preliminary evidence suggests high dose fractionated radiotherapy, such as SBRT, in combination with systemic immunotherapy has a synergistic effect and may enhance survival<sup>2</sup>. Durvalumab (PD-L1 antibody) is approved as consolidation therapy for unresectable, locally advanced NSCLC who have not progressed following chemoradiotherapy. These findings support further investigation of durvalumab + SBRT combinations in oligometastatic NSCLC who received standard systematic therapy. <h3>Methods</h3> SABRCURE is an open-label, phase 2 study evaluating the efficacy and safety of durvalumab combined with SBRT and chemotherapy in oligometastatic stage IV NSCLC. Key eligibility criteria include no more than 5 metastatic lesions in up to 3 organs, EGFR/ALK/ROS1 wild type, no previous systemic therapy or brain metastases. Forty patients will be enrolled and receive durvalumab 1500mg + platinum-doublet chemotherapy every 3 weeks for 4 cycles, and then durvalumab 1500mg every 4 weeks monotherapy until disease progression or up to 24 months. Patient without progression after 4 cycles durvalumab + chemotherapy will receive stereotactic body radiotherapy. SBRT will be started within 2 weeks after chemotherapy completion and administered to primary lesion and all known metastatic lesions, with a total dose of 50-60Gy in≤10 fractions. The primary endpoint is progression free survival (PFS) per RECIST v1.1. Secondary end points are objective response rate (ORR), overall survival (OS) , safety and treatment failure pattern. This study was funded by AstraZeneca China. <h3>Trial Registration</h3> NCT04255836 <h3>References</h3> Gomez DR, Tang C, Zhang J, <i>et al</i>. Local consolidative therapy vs. maintenance therapy or observation for patients with oligometastatic non–small-cell lung cancer: long-term results of a multi-institutional, phase II, randomized study. <i>J. Clin. Oncol.</i> 2019;<b>37</b>(18):1558. Azghadi S, Daly ME. Radiation and immunotherapy combinations in non-small cell lung cancer. <i>Cancer Treatment and Research Communications</i>. 2021;<b>26</b>:100298. <h3>Ethics Approval</h3> This study was approved by Cancer Hospital of the University of Chinese Academy of Sciences Ethics Committee. <h3>Consent</h3> Written informed consent was obtained from the patient for publication of this abstract." @default.
- W4308385285 created "2022-11-11" @default.
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- W4308385285 date "2022-11-01" @default.
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- W4308385285 title "698 A phase 2 study of durvalumab combined with chemotherapy and stereotactic body radiotherapy (SBRT) in patients with oligometastatic non-small cell lung cancer (NSCLC) (SABRCURE trial)" @default.
- W4308385285 doi "https://doi.org/10.1136/jitc-2022-sitc2022.0698" @default.
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