Seneca Valley Virus-001 After Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Summary

RATIONALE: A virus called Seneca Valley virus-001 (NTX-010) may be able to kill tumor cells without damaging normal cells. It is not yet known whether NTX-010 is more effective than a placebo in treating small cell lung cancer. PURPOSE: This randomized phase II trial is studying NTX-010 to see how well it works compared with a placebo when given after chemotherapy in treating patients with extensive-stage small cell lung cancer.

Timeline

Start

2010-01

Primary completion

2013-01

Completion

2014-11-15

Outcome

Missed primary endpoint

Stopped: “Interim analysis declared futility.”

paper median PFS was 1.7 months (95% confidence interval [CI]: 1.4-3.1 months) for the NTX-010 group versus 1.7 months PMID 31605793 ↗

paper hazard ratio = 1.03, p = 0.92 PMID 31605793 ↗

paper Patients with ES SCLC did not benefit from NTX-010 treatment after chemotherapy with a platinum doublet. PMID 31605793 ↗

Publications

• Schenk EL, Mandrekar SJ, Dy GK, Aubry MC, Tan AD, Dakhil SR, Sachs BA, Nieva JJ, Bertino E, Lee Hann C, Schild SE, Wadsworth TW, Adjei AA, Molina JR. 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. J Thorac Oncol. 2020 Jan;15(1):110-119. doi: 10.1016/j.jtho.2019.09.083. Epub 2019 Oct 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Seneca Valley virus-001	Other / unclassified	—	Intravenous

Indications