This study will enroll patients with locally advanced or metastatic non-EGFR mutated Non-Small Cell Lung Cancer (NSCLC) lung cancer after failure of at least one but no more than two prior approved treatment regimens. Patients will be randomized to receive one of two doses of vaccine or placebo to be dosed twice weekly for 18 weeks (36 doses total) and patients will also receive erlotinib 150mg taken orally once daily for the duration of the trial. The study will examine the immune effects, safety and efficacy of two different doses of HS110 vaccine in combination with erlotinib versus erlotinib alone.
Name: HS110 vaccine
Description: 0.5ml to be administered twice weekly for 18 weeks (36 doses)Type: BiologicalLow-dose HS-110
Name: Placebo
Description: 0.5ml buffered saline placebo to be administered twice weekly for 18 weeks (36 doses)Type: BiologicalPlacebo vaccine + erlotinib 150mg orally once daily
Name: HS110 vaccine
Description: 0.5 mls to be dosed twice weekly for 18 weeks (36 doses)Type: BiologicalHigh dose HS110
Description: Immune response will be evalulated by ELISPOT assays and change will be assessed from baseline.
Measure: Immunologic Response (defined as production of IFNÆ´ from CD8+ T cells as evaluated by ELISPOT assay) Time: Week 18Description: Incidence and severity of adverse events, changes in laboratory measures, physical exams and evaluation of autoimmune phenomena.
Measure: Safety of the combination of HS110 vaccine and erlotinib Time: Up to 1 yearDescription: Patients will have a CT scan performed at baseline, Week 12 and Week 22 or at the end of study visit in the case of early termination from study. Investigators will assess the disease response using irRC for overall response, CR, PR, SD or PD.
Measure: Tumor assessment by immunologic response criteria (irRC) Time: Baseline, Week 12 and Week 22Description: Analysis via a semiautomated, epithelial cell adhesion molecule-based immunomagnetic technique.
Measure: Exploratory Immunologic endpoint - evaluation of circulating tumor cells Time: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12 and Week 18Description: Analysis of cell surfance molecules by flow cytometry
Measure: Exploratory immunologic endpoint - immune function Time: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12 and Week 18Description: Examination of protein expression utilizing western blot, immunohistochemical staining, enzyme linked immunosorbent assay (ELISA) or mass spectrometry
Measure: Exploratory immunologic endpoint - proteomic profile Time: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12 and Week 18Allocation: Randomized
Parallel Assignment
There is one SNP
Non-small Cell Lung Cancer Lung Neoplasms Carcinoma, Non-Small-Cell Lung This multicenter, randomized, double-blind, placebo-controlled study will enroll patients with advanced NSCLC (squamous cell or non-squamous cell) without EGFR mutations (either L858R or 746-750 deletions) who have had progression or recurrence of their disease following at least one but no more than two prior regimens (adjuvant therapy excluded) of approved therapy that did not include immunomodulating or anti-EGFR targeted therapy for their disease. --- L858R ---