A Phase 2 Study of Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Drug: Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed)
- Registration Number
- NCT02117024
- Lead Sponsor
- Heat Biologics
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 66
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Viagenpumatucel-L Plus Metronomic Cyclophosphamide Viagenpumatucel-L Viagenpumatucel-L (HS-110) given as 1\*10\^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks. Viagenpumatucel-L Plus Metronomic Cyclophosphamide Metronomic Cyclophosphamide Viagenpumatucel-L (HS-110) given as 1\*10\^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks. Chemotherapy Alone Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed) Patients will be treated with a physician's choice regimen until progression.
- Primary Outcome Measures
Name Time Method Overall Survival (OS) Up to 3 years 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
- Secondary Outcome Measures
Name Time Method Progression-Free Survival (PFS) Up to 3 years Evaluate immune-related PFS (irPFS) and PFS by RECIST (Response Evaluation Criteria for Solid Tumors)
Time to Progression (TTP) Up to 3 years Evaluate immune-related TTP (irTTP) and also TTP (Time to Progression) by RECIST
Survival at 6 Months 6 months Evaluate the proportion of patients who are alive at 6 months following randomization
Survival at 12 Months 12 months Evaluate the proportion of patients who are alive at 12 months following randomization
Immune Response Up to 3 years 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
6-Month Disease Control Rate (6mDCR) 6 months 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)
Overall Response Rate (ORR) Up to 3 years Evaluate immune-related ORR (irORR) and also ORR by RECIST (complete response and partial response)
Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE) Up to 3 years Evaluate the safety of the combination of viagenpumatucel-L and low-dose cyclophosphamide by frequency of Treatment-Emergent Adverse Events
Disease Control Rate (DCR) Up to 3 years Evaluate overall immune-related DCR (irDCR) and also DCR by Response Evaluation Criteria in Solid Tumors (RECIST) (complete response, partial response, and stable disease)
Trial Locations
- Locations (16)
Gabrail Cancer Center
🇺🇸Canton, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of California Davis
🇺🇸Sacramento, California, United States
Highlands Oncology Group
🇺🇸Rogers, Arkansas, United States
University of Maryland Greenebaum Cancer Center
🇺🇸Baltimore, Maryland, United States
Providence Portland Medical Center- Providence Lung Cancer Clinic
🇺🇸Portland, Oregon, United States
Mary Crowley Cancer Center
🇺🇸Dallas, Texas, United States
Georgia Regents University
🇺🇸Augusta, Georgia, United States
University of California at Los Angeles
🇺🇸Los Angeles, California, United States
University of Massachusetts
🇺🇸Worcester, Massachusetts, United States
SUNY Syracuse
🇺🇸Syracuse, New York, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Cancer Care Northwest
🇺🇸Spokane, Washington, United States
Aurora Research Institute
🇺🇸Green Bay, Wisconsin, United States
Texas Oncology PA Texas Cancer Center
🇺🇸Abilene, Texas, United States
University of California San Diego
🇺🇸La Jolla, California, United States