A Phase 2 Study of Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Viagenpumatucel-L; Metronomic Cyclophosphamide; Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed)
Intervention description: Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig; One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks; 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 MeSH terms: Paclitaxel; Vinorelbine; Docetaxel; Cyclophosphamide; Gemcitabine; Pemetrexed; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: lung; cancer; gp96; vaccine; immunotherapy; Heat Biologics; cyclophosphamide; vinorelbine; erlotinib; gemcitabine; paclitaxel; docetaxel; pemetrexed

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.
    

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