A Phase 2 Study of Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer
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.
Checked against the public recordLast updated Feb 5, 2020 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Heat Biologics
- Interventions being studied
- Drug: Viagenpumatucel-L; Drug: Metronomic Cyclophosphamide; Drug: Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed)
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Non-small cell lung adenocarcinoma * At least 2 and no more than 3 prior lines of therapy for incurable or metastatic NSCLC * Suitable for conventional single agent chemotherapy * Disease progression at study entry * Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1; PS=2 patients may be considered * Central nervous system (CNS) metastases may be permitted but must be treated and neurologically stable * Adequate laboratory parameters * Willing and able to comply with the protocol and sign informed consent * Female patients who are of childbearing potential and fertile male patients must agree to use an effective form of contraception throughout study participation Exclusion Criteria: * Received systemic anticancer therapy or radiation therapy within the previous 14 days * Received more than 3 lines of prior conventional therapy for advanced disease * Human immunodeficiency virus (HIV), hepatitis B or C, or severe/uncontrolled infections or intercurrent illness, unrelated to the tumor, requiring active therapy * Any condition requiring concurrent systemic immunosuppressive therapy * Known immunodeficiency disorders * Known leptomeningeal disease * Other active malignancies * Prior treatment with a cancer vaccine for this indication * Pregnant or breastfeeding
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Highlands Oncology GroupRogers, Arkansas
- University of California San DiegoLa Jolla, California
- University of California at Los AngelesLos Angeles, California
- University of California DavisSacramento, California
- Georgia Regents UniversityAugusta, Georgia
- University of Maryland Greenebaum Cancer CenterBaltimore, Maryland
- University of MassachusettsWorcester, Massachusetts
- Washington University School of MedicineSt Louis, Missouri
- SUNY SyracuseSyracuse, New York
- Gabrail Cancer CenterCanton, Ohio
- Providence Portland Medical Center- Providence Lung Cancer ClinicPortland, Oregon
- University of PennsylvaniaPhiladelphia, Pennsylvania
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 5, 2020. Always confirm current availability with the study team.