Phase III Lucanix™ Vaccine Therapy in Advanced Non-small Cell Lung Cancer (NSCLC) Following Front-line Chemotherapy
Condition: Lung Neoplasm; Carcinoma Non-small Cell Lung Cancer Stage IIIA; Carcinoma Non-small Cell Lung Cancer Stage IIIB; Carcinoma Non-small Cell Lung Cancer Stage IV
MeSH terms: Carcinoma; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      Rationale: Vaccines made from gene-modified tumor cells may help the body build an immune
      response to kill tumor cells. It is not yet known whether vaccine therapy is more effective
      than a placebo as maintenance therapy in treatment of subjects with non-small cell lung
      cancer.

      Purpose: This randomized phase III trial is studying vaccine therapy to see how well it works
      compared with a placebo in treating subjects with stage III or stage IV non-small cell lung
      cancer.
    

Detailed description: 
      Primary Efficacy Endpoints:

        -  Compare the overall survival of subjects with stage III or IV non-small cell lung cancer
           treated with belagenpumatucel-L (Lucanix™) vs placebo.

      Secondary Efficacy Endpoints:

        -  Evaluate the progression free survival (PFS) of subjects treated with Lucanix™ compared
           to treatment within the BSC control group.

        -  Evaluate the quality of life (QOL) as determined by the Lung Cancer Symptom Scale (LCSS)
           compared to treatment within the BSC control group.

        -  Evaluate the time-to-progression of subjects treated with Lucanix™ compared to treatment
           within the BSC control group.

        -  Evaluate the best overall tumor response in subjects treated with Lucanix™ compared to
           treatment in the BSC control group.

        -  Evaluate the response duration in subjects treated with Lucanix™ compared to the BSC
           control group.

        -  Evaluate the rate of CNS metastases development in subjects treated with Lucanix™ as
           compared to the BSC control group.

        -  Adverse events of subjects treated with Lucanix™ will be compared to subjects in the
           control group.

      Outline: This is a multicenter study. Subjects are stratified according to disease stage
      (IIIA vs IIIB or IV), response to prior treatment with front-line chemotherapy (stable
      disease vs partial response or complete response), prior treatment with front-line
      chemotherapy and radiotherapy (front-line chemotherapy with radiotherapy vs front-line
      chemotherapy alone), and prior treatment with front-line chemotherapy and other anticancer
      therapy (front-line chemotherapy with bevacizumab vs front-line chemotherapy alone or in
      combination with another anticancer agent). Subjects are randomized to 1 of 2 treatment arms.

        -  Treatment Arm: Subjects receive belagenpumatucel-L (Lucanix™) intradermally (ID) once
           monthly for 18 months and then once at 21 and 24 months in the absence of disease
           progression or unacceptable toxicity.

        -  Control Arm: Subjects receive placebo ID once monthly for 18 months and then once at 21
           and 24 months in the absence of disease progression or unacceptable toxicity.

      Blood samples are collected and analyzed for routine chemistry, cytokines, chemokines, and
      some instances circulating tumor cells, including response to multiple lung cancer-associated
      antigens by IFN-γ ELISPOT CD8+ assay; CEA by CD4 class II assay; lung tumor-associated
      antigens by in vitro proliferation assays; regulatory T-cell (Treg) phenotype by flow
      cytometry; and Treg function.

      Subjects complete the Lung Cancer Symptom Scale quality of life questionnaire at baseline, on
      the days of treatment, 30 days after completion of study treatment, and then every 3 months
      for 1 year.

      After completion of study treatment, subjects are followed every 3 months for 1 year and then
      annually for 4 years.

      In two phase II trials, many subjects who received Lucanix™ at the same dose that will be
      administered in this trial had long-term disease stability with a good quality of life.
    

Intervention name(s): Lucanix™; Placebo Comparator
Intervention type(s): Biological; Other
Intervention description(s): Treatment Arm: Subjects receive Lucanix™ (belagenpumatucel-L) intradermally (ID) once monthly for 18 months and then once at 21 and 24 months in the absence of disease progression or unacceptable toxicity.; Control Arm: Subjects receive placebo ID once monthly for 18 months and then once at 21 and 24 months in the absence of disease progression or unacceptable toxicity.
Other intervention name(s): belagenpumatucel-L
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Gene therapy; Flow cytometry; Immunoenzyme technique; Laboratory biomarker analysis; Quality-of-life-assessment; Tumor cell-derivative vaccine therapy