@article{86eed792105f4cd6a3659f6074a6b8de,
title = "A Randomized Double-Blind Phase II Study of the Seneca Valley Virus (NTX-010) versus Placebo for Patients with Extensive-Stage SCLC (ES SCLC) Who Were Stable or Responding after at Least Four Cycles of Platinum-Based Chemotherapy: North Central Cancer Treatment Group (Alliance) N0923 Study",
abstract = "Introduction: The Seneca Valley virus (NTX-010) is an oncolytic picornavirus with tropism for SCLC. This phase II double-blind, placebo-controlled trial evaluated NTX-010 in patients with extensive-stage (ES) SCLC after completion of first-line chemotherapy. Methods: Patients with ES SCLC who did not progress after four or more cycles of platinum-based chemotherapy were randomized 1:1 to a single dose of NTX-010 or placebo within 12 weeks of chemotherapy. The primary end point was progression-free survival (PFS). A prespecified interim analysis for futility was performed after 40 events. Viral clearance and the development of neutralizing antibodies were followed. Results: From January 15, 2010, to January 10, 2013, a total of 50 patients were randomized and received therapy on study (26 received NTX-010 and 24 received placebo). At the specified interim analysis, the median PFS was 1.7 months (95% confidence interval [CI]: 1.4–3.1 months) for the NTX-010 group versus 1.7 months (95% CI: 1.4–4.3 months) for the placebo group (hazard ratio = 1.03, p = 0.92), and the trial was terminated owing to futility. In the NTX-010 group, PFS was shorter in patients with detectable virus at days 7 and 14 versus in those in whom it was not detected after treatment (1.0 month [95% CI: 0.4–1.5 months] versus 1.8 months [95% CI: 1.3–5.5 months, p = 0.008] and 0.9 months [95% CI: 0.4–2.6 months] versus 1.3 months [95% CI: 1.0–5.3 months], respectively [p = 0.04]). Conclusions: Patients with ES SCLC did not benefit from NTX-010 treatment after chemotherapy with a platinum doublet. Persistence of NTX-010 in the blood 1 or 2 weeks after treatment was associated with a shorter PFS.",
keywords = "NTX-010, Seneca valley virus, Small cell lung cancer, Virotherapy",
author = "Schenk, {Erin L.} and Mandrekar, {Sumithra J.} and Dy, {Grace K.} and Aubry, {Marie Christine} and Tan, {Angelina D.} and Dakhil, {Shaker R.} and Sachs, {Bradley A.} and Nieva, {Jorge J.} and Erin Bertino and {Lee Hann}, Christine and Schild, {Steven E.} and Wadsworth, {Troy W.} and Adjei, {Alex A.} and Molina, {Julian R.}",
note = "Funding Information: The research reported in this publication was supported by the National Cancer Institute of the National Institutes of Health under the award numbers U10CA180821 and U10CA180882 (to the Alliance for Clinical Trials in Oncology ); U10CA180866 , U10CA180790 , U10CA180791 , U10CA233196 , U10CA233290 , U10CA180820 and UG1CA189952 (to the Eastern Cooperative Oncology Group– American College of Radiology Imaging Network ), and U10CA180888 (to SWOG). It was also supported in part by funds from Neotropix, Inc. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health . The following institutional networks participated in this study: MedStar Georgetown University Hospital, Washington, DC; Filipa Lynce and The Ohio State University Comprehensive Cancer Center LAPS, Columbus, Ohio; and Claire Verschraegen ( U10CA180850 ). Funding Information: The research reported in this publication was supported by the National Cancer Institute of the National Institutes of Health under the award numbers U10CA180821 and U10CA180882 (to the Alliance for Clinical Trials in Oncology); U10CA180866, U10CA180790, U10CA180791, U10CA233196, U10CA233290, U10CA180820 and UG1CA189952 (to the Eastern Cooperative Oncology Group? American College of Radiology Imaging Network), and U10CA180888 (to SWOG). It was also supported in part by funds from Neotropix, Inc. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The following institutional networks participated in this study: MedStar Georgetown University Hospital, Washington, DC; Filipa Lynce and The Ohio State University Comprehensive Cancer Center LAPS, Columbus, Ohio; and Claire Verschraegen (U10CA180850). Publisher Copyright: {\textcopyright} 2019 International Association for the Study of Lung Cancer",
year = "2020",
month = jan,
doi = "10.1016/j.jtho.2019.09.083",
language = "English (US)",
volume = "15",
pages = "110--119",
journal = "Journal of Thoracic Oncology",
issn = "1556-0864",
publisher = "International Association for the Study of Lung Cancer",
number = "1",
}