A Phase 2 Study of Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02117024
• Other study ID #: HS110-201
• Status: Terminated
• Phase: Phase 2
• Start date: July 2014
• Est. completion date: April 2018

Study information

• Verified date: January 2020
• Source: Heat Biologics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 66
• Est. completion date: April 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• Viagenpumatucel-L
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
• 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

Locations

Country	Name	City	State
United States	Texas Oncology PA Texas Cancer Center	Abilene	Texas
United States	Georgia Regents University	Augusta	Georgia
United States	University of Maryland Greenebaum Cancer Center	Baltimore	Maryland
United States	Gabrail Cancer Center	Canton	Ohio
United States	Mary Crowley Cancer Center	Dallas	Texas
United States	Aurora Research Institute	Green Bay	Wisconsin
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 Pennsylvania	Philadelphia	Pennsylvania
United States	Providence Portland Medical Center- Providence Lung Cancer Clinic	Portland	Oregon
United States	Highlands Oncology Group	Rogers	Arkansas
United States	University of California Davis	Sacramento	California
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Cancer Care Northwest	Spokane	Washington
United States	SUNY Syracuse	Syracuse	New York
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Heat Biologics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 3 years
Secondary	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	Up to 3 years
Secondary	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)	Up to 3 years
Secondary	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)	6 months
Secondary	Overall Response Rate (ORR)	Evaluate immune-related ORR (irORR) and also ORR by RECIST (complete response and partial response)	Up to 3 years
Secondary	Progression-Free Survival (PFS)	Evaluate immune-related PFS (irPFS) and PFS by RECIST (Response Evaluation Criteria for Solid Tumors)	Up to 3 years
Secondary	Time to Progression (TTP)	Evaluate immune-related TTP (irTTP) and also TTP (Time to Progression) by RECIST	Up to 3 years
Secondary	Survival at 6 Months	Evaluate the proportion of patients who are alive at 6 months following randomization	6 months
Secondary	Survival at 12 Months	Evaluate the proportion of patients who are alive at 12 months following randomization	12 months
Secondary	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	Up to 3 years