Evidence map›Paper›PMID 31605793›Full record

Trial reportJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2020

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.

Erin L Schenk, Sumithra J Mandrekar, Grace K Dy, Marie Christine Aubry, Angelina D Tan, Shaker R Dakhil, Bradley A Sachs, Jorge J Nieva, Erin Bertino, Christine Lee Hann and 4 more

Open access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 50 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 3 pooled it
5.3field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

50 citing papers in PubMed, 3 syntheses or guidelines pooled it, 64 citations in OpenAlex.

  1. Pooled it
  2. Clinical Application of Oncolytic Viruses: A Systematic Review.International journal of molecular sciences · 2020
    Pooled it
  3. Pooled it
  4. Review
  5. Review
  6. Review
  7. Article
  8. Oncolytic viruses: advanced strategies in cancer therapy.Signal transduction and targeted therapy · 2026
    Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. Review
  14. Article
  15. Review
  16. Review
  17. Exploring treatment options in cancer: Tumor treatment strategies.Signal transduction and targeted therapy · 2024
    Review
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  19. Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 10 institutions in 1 country.

Erin L SchenkUniversity of Colorado, Aurora, Colorado.
Sumithra J MandrekarAlliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota; Mayo Clinic, Rochester, Minnesota.
Grace K DyRoswell Park Comprehensive Cancer Center, Buffalo, New York.
Marie Christine AubryMayo Clinic, Rochester, Minnesota.
Angelina D TanAlliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota; Mayo Clinic, Rochester, Minnesota.
Shaker R DakhilCancer Center of Kansas, Newton, Kansas.
Bradley A SachsThe Toledo Clinic-Maumee, Maumee, Ohio.
Jorge J NievaUniversity of Southern California, Los Angeles, California.
Erin BertinoThe Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
Christine Lee HannJohns Hopkins University, Baltimore, Maryland.
Steven E SchildMayo Clinic, Scottsdale, Arizona.
Troy W WadsworthNorthwest NCORP, Multicare Regional Cancer Center, Tacoma, Washington.
Alex A AdjeiMayo Clinic, Rochester, Minnesota.
Julian R MolinaMayo Clinic, Rochester, Minnesota. Electronic address: molina.julian@mayo.edu.
Mayo Clinic · USCancer Center of Kansas · USJohns Hopkins University · USMayo Clinic in Arizona · USRegional Cancer Center · USRoswell Park Comprehensive Cancer Center · USThe Ohio State University · USToledo Clinic Cancer Center · USUniversity of Colorado Anschutz Medical Campus · USUniversity of Southern California · US

Funding

Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer · 2014 to 2026
$167.6M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
Network Lead Academic Participating Site: Memorial Sloan Kettering Cancer CenterUG1CA233290 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI CAROL AGHAJANIAN, Darren Feldman · 2019 to 2026
$10.2M
OSU as a Network Lead Academic Participating Site for the NCI NCTNUG1CA233331 · NCI · OHIO STATE UNIVERSITY · PI John L. Hays, Dwight H. Owen · 2019 to 2026
$8.9M
NCI, National Clinical Trials Network Lead Academic Participating Site (LAPS) UG1 (funded extension)UG1CA232760 · NCI · MAYO CLINIC ROCHESTER · PI Judy Caroline Boughey, Aaron Scott Mansfield · 2019 to 2026
$8.5M
OSU as Network Lead Academic Participating Site for the NCI NCTNU10CA180850 · NCI · OHIO STATE UNIVERSITY · PI BLUM, KRISTIE A, CHAKRAVARTI, ARNAB · 2014 to 2018
$6.8M
Naional Cancer Institute, Naitonal Clinical Trials Network U10 Lead Academic SiteU10CA180790 · NCI · MAYO CLINIC ROCHESTER · PI ALBERTS, STEVEN R, BOUGHEY, JUDY CAROLINE · 2014 to 2018
$6.6M
NCI National Clinical Trials Network - Lead Academic Participating SiteUG1CA233324 · NCI · UNIVERSITY OF COLORADO DENVER · PI ANTHONY D ELIAS · 2019 to 2026
$5.2M
Network Lead Academic Participating Site: Memorial Sloan-Kettering Cancer CenterU10CA180791 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI AGHAJANIAN, CAROL, MORRIS, MICHAEL J · 2014 to 2018
$4.6M
NCTN LAPS at Johns HopkinsUG1CA233196 · NCI · JOHNS HOPKINS UNIVERSITY · PI DEBORAH K ARMSTRONG, Julie Renee Brahmer · 2019 to 2026
$4.6M
NCI NIH HHS U10 CA180790NCI NIH HHS U10 CA180791NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180850NCI NIH HHS U10 CA180866NCI NIH HHS U10 CA180882NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA189952NCI NIH HHS UG1 CA232760NCI NIH HHS UG1 CA233191NCI NIH HHS UG1 CA233196NCI NIH HHS UG1 CA233290NCI NIH HHS UG1 CA233324NCI NIH HHS UG1 CA233331
6 · The paper itself

Abstract

introductionThe 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.

methodsPatients 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.

resultsFrom 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]).

conclusionsPatients 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.

Indexed as

Lung NeoplasmsPlatinumAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCisplatinDouble-Blind MethodEtoposideHumansPicornaviridaeCarboplatinCisplatinEtoposidePlatinumNTX-010Seneca valley virusSmall cell lung cancerVirotherapy

Identifiers

PMID31605793
PMCPMC7279615
OpenAlexW2979929480

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.