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Brief Title: A Phase 2 Study of Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer
Official Title: 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
Study ID: NCT02117024
Brief 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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, Saint 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
Name: Roger Cohen, MD
Affiliation: University of Pennsylvania
Role: PRINCIPAL_INVESTIGATOR