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

NCT ID: NCT02117024

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2018-04-30

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.

Conditions

Non Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Viagenpumatucel-L Plus 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.

Group Type: EXPERIMENTAL

Viagenpumatucel-L

Intervention Type: DRUG

Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig

Metronomic Cyclophosphamide

Intervention Type: DRUG

One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks

Chemotherapy Alone

Patients will be treated with a physician's choice regimen until progression.

Group Type: ACTIVE_COMPARATOR

Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed)

Intervention Type: DRUG

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

Interventions

Viagenpumatucel-L

Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

HS-110

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heat Biologics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roger Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Highlands Oncology Group

Rogers, Arkansas, 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 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

Providence Portland Medical Center- Providence Lung Cancer Clinic

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Texas Oncology PA Texas Cancer Center

Abilene, Texas, United States

Mary Crowley Cancer Center

Dallas, Texas, United States

Cancer Care Northwest

Spokane, Washington, United States

Aurora Research Institute

Green Bay, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HS110-201

Identifier Type: -

Identifier Source: org_study_id