Clinical trial NCT02117024: 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Keywords: lung
cancer
gp96
vaccine
immunotherapy
Heat Biologics
cyclophosphamide
vinorelbine
erlotinib
gemcitabine
paclitaxel
docetaxel
pemetrexed
Lead sponsor: Heat Biologics
Sponsor class: INDUSTRY
First posted: 2014-04-17
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 3 years
Secondary outcomes:
measure: Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
timeFrame: Up to 3 years
measure: Disease Control Rate (DCR)
timeFrame: Up to 3 years
measure: 6-Month Disease Control Rate (6mDCR)
timeFrame: 6 months
measure: Overall Response Rate (ORR)
timeFrame: Up to 3 years
measure: Progression-Free Survival (PFS)
timeFrame: Up to 3 years
measure: Time to Progression (TTP)
timeFrame: Up to 3 years
measure: Survival at 6 Months
timeFrame: 6 months
measure: Survival at 12 Months
timeFrame: 12 months
measure: Immune Response
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Rogers
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Los Angeles
country: United States
facility: University of California at Los Angeles
state: California
city: Sacramento
country: United States
facility: University of California Davis
state: California
city: Augusta
country: United States
facility: Georgia Regents University
state: Georgia
city: Baltimore
country: United States
facility: University of Maryland Greenebaum Cancer Center
state: Maryland
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Syracuse
country: United States
facility: SUNY Syracuse
state: New York
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Portland
country: United States
facility: Providence Portland Medical Center- Providence Lung Cancer Clinic
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Abilene
country: United States
facility: Texas Oncology PA Texas Cancer Center
state: Texas
city: Dallas
country: United States
facility: Mary Crowley Cancer Center
state: Texas
city: Spokane
country: United States
facility: Cancer Care Northwest
state: Washington
city: Green Bay
country: United States
facility: Aurora Research Institute
state: Wisconsin
Study officials:
affiliation: University of Pennsylvania
name: Roger Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References: