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



Status:Completed
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/24/2019
Start Date:July 2014
End Date:April 2018

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A Phase 2, Multicenter, Randomized Study to Evaluate the Safety and Efficacy of Viagenpumatucel-L (HS-110) in Combination With Low Dose (Metronomic) Cyclophosphamide Versus Chemotherapy Alone in Patients With Non-Small Cell Lung Adenocarcinoma After Failure of Two or Three Previous Treatment Regimens for Advanced Disease

This study will test whether vaccination with viagenpumatucel-L combined with low-dose
cyclophosphamide will prolong the survival of patients with non-small cell lung cancer
(NSCLC) who have failed 2 or 3 prior lines of therapy for incurable or metastatic disease
compared with chemotherapy alone. Patients will be randomized 2 to 1 into the
viagenpumatucel-L arm and the chemotherapy alone arm, respectively.


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
We found this trial at
16
sites
Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
979
mi
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Los Angeles, CA
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1580
mi
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Abilene, TX
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1120 15th Street
Augusta, Georgia 30912
(706) 721-0211
Georgia Regents University Georgia Regents University, home of the Medical College of Georgia, is one...
2300
mi
from 98109
Augusta, GA
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22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
2327
mi
from 98109
Baltimore, MD
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4875 Higbee Ave NW
Canton, Ohio 44718
330-492-3345
Gabrail Cancer Center Since 1990, Gabrail Cancer Center has built a national reputation for excellence...
2052
mi
from 98109
Canton, OH
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Dallas, Texas 75201
1680
mi
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Dallas, TX
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Green Bay, Wisconsin 54311
1645
mi
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Green Bay, WI
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
1056
mi
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La Jolla, CA
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
2371
mi
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Philadelphia, PA
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146
mi
from 98109
Portland, OR
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Rogers, Arkansas 72758
1632
mi
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Rogers, AR
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1 Shields Ave
Sacramento, California 95616
(530) 752-1011
University of California-Davis As we begin our second century, UC Davis is poised to become...
627
mi
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Sacramento, CA
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
1718
mi
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Saint Louis, MO
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Spokane, Washington 99218
229
mi
from 98109
Spokane, WA
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Syracuse, New York 13210
2231
mi
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Syracuse, NY
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Worcester, Massachusetts 01655
2455
mi
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Worcester, MA
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