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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks
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
Highlands Oncology Group
Rogers, Arkansas, United States
University of California San Diego
La Jolla, California, United States
Overall Survival (OS)
Overall survival (OS) calculated as the duration of survival from the date of randomization to the date of death from any cause, or was censored on the date the patient was last known to be alive. Survival time was calculated from the randomization date up to the date of death,or censored on the date that the patient was last known to be alive (last available visit date) utilizing Kaplan-Meier Estimate of Overall Survival Ending Events
Time frame: Up to 3 years
Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
Evaluate the safety of the combination of viagenpumatucel-L and low-dose cyclophosphamide by frequency of Treatment-Emergent Adverse Events
Time frame: Up to 3 years
Disease Control Rate (DCR)
Evaluate overall immune-related DCR (irDCR) and also DCR by Response Evaluation Criteria in Solid Tumors (RECIST) (complete response, partial response, and stable disease)
Time frame: Up to 3 years
6-Month Disease Control Rate (6mDCR)
Evaluate 6-month immune-related DCR (6m-irDCR) and also 6mDCR by RECIST (complete response, partial response, and stable disease at 6 months following randomization)
Time frame: 6 months
Overall Response Rate (ORR)
Evaluate immune-related ORR (irORR) and also ORR by RECIST (complete response and partial response)
Time frame: Up to 3 years
Progression-Free Survival (PFS)
Evaluate immune-related PFS (irPFS) and PFS by RECIST (Response Evaluation Criteria for Solid Tumors)
Time frame: Up to 3 years
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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
...and 6 more locations
Time to Progression (TTP)
Evaluate immune-related TTP (irTTP) and also TTP (Time to Progression) by RECIST
Time frame: Up to 3 years
Survival at 6 Months
Evaluate the proportion of patients who are alive at 6 months following randomization
Time frame: 6 months
Survival at 12 Months
Evaluate the proportion of patients who are alive at 12 months following randomization
Time frame: 12 months
Immune Response
Characterize the peripheral blood immunologic response via intracellular cytokine staining (ICS) by flow cytometry and/or enzyme-linked immunosorbent spot (ELISPOT) on cluster of differentiation 8 positive (CD8+) cells following vaccination
Time frame: Up to 3 years