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A Phase 2 Study of Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer

NCT02117024 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2020-02-05

Study results available
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Summary

Determine whether viagenpumatucel-L combined with low-dose cyclophosphamide prolongs survival in patients with NSCLC who failed 2 or 3 prior lines of therapy for incurable or metastatic disease compared with chemotherapy alone.

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

Viagenpumatucel-L

Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig

DRUG

Metronomic Cyclophosphamide

One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks

DRUG

Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed)

Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice: * Vinorelbine * Erlotinib * Gemcitabine * Paclitaxel * Docetaxel * Pemetrexed

Sponsors & Collaborators

  • Heat Biologics

    lead INDUSTRY

Principal Investigators

  • Roger Cohen, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2017-12-31
Completion
2018-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02117024 on ClinicalTrials.gov