This trial is active, not recruiting.

Condition non small cell lung cancer
Treatments viagenpumatucel-l, metronomic cyclophosphamide, physician's choice regimen (vinorelbine, erlotinib, gemcitabine, paclitaxel, docetaxel, pemetrexed)
Phase phase 2
Sponsor Heat Biologics
Start date July 2014
End date June 2017
Trial size 123 participants
Trial identifier NCT02117024, HS110-201


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
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 HS-110
Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
metronomic cyclophosphamide
One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks
(Active Comparator)
Patients will be treated with a physician's choice regimen until progression.
physician's choice regimen (vinorelbine, erlotinib, gemcitabine, paclitaxel, docetaxel, pemetrexed)
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

Primary Outcomes

Overall survival (OS)
time frame: Up to 3 years

Secondary Outcomes

time frame: Up to 3 years
Disease Control Rate (DCR)
time frame: Up to 3 years
6-Month Disease Control Rate (6mDCR)
time frame: 6 months
Overall Response Rate (ORR)
time frame: Up to 3 years
Progression-Free Survival (PFS)
time frame: Up to 3 years
Time to Progression (TTP)
time frame: Up to 3 years
Survival at 6 months
time frame: 6 months
Survival at 12 months
time frame: 12 months
Immune Response
time frame: Up to 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Roger Cohen, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Heat Biologics.