Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

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.

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

Keywords

Non Small Cell Lung Cancer lung cancer gp96 vaccine immunotherapy Heat Biologics cyclophosphamide vinorelbine erlotinib gemcitabine paclitaxel docetaxel pemetrexed Lung Neoplasms Carcinoma, Non-Small-Cell Lung Albumin-Bound Paclitaxel Erlotinib Hydrochloride Viagenpumatucel-L Metronomic Cyclophosphamide Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed) Viagenpumatucel-L Plus Metronomic Cyclophosphamide Chemotherapy Alone

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California San Diego
    La Jolla California 92093 United States
  • University of California at Los Angeles
    Los Angeles California 90029 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Heat Biologics
ID
NCT02117024
Phase
Phase 2
Study Type
Interventional
Last Updated