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

Stopped early · Phase 2

Conditions studied: Non Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT02117024

Run by

Heat Biologics

People needed

66

Starts

2014-07-01

Expected to finish

2018-04-01

Last updated by the study team

2020-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Highlands Oncology Group — Rogers, Arkansas, United States
• University of California San Diego — La Jolla, California, United States
• University of California at Los Angeles — Los Angeles, California, United States
• University of California Davis — Sacramento, California, United States
• Georgia Regents University — Augusta, Georgia, United States
• University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States
• University of Massachusetts — Worcester, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• SUNY Syracuse — Syracuse, New York, United States
• Gabrail Cancer Center — Canton, Ohio, United States
• Providence Portland Medical Center- Providence Lung Cancer Clinic — Portland, Oregon, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Texas Oncology PA Texas Cancer Center — Abilene, Texas, United States
• Mary Crowley Cancer Center — Dallas, Texas, United States
• Cancer Care Northwest — Spokane, Washington, United States
• Aurora Research Institute — Green Bay, Wisconsin, United States

Full record on ClinicalTrials.gov

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