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Report for Clinical Trial NCT01504542

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 2A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Immune Response, Safety and Efficacy of HS-110 in Combination With Erlotinib vs. Erlotinib as a Single Agent in Patients With Advanced, Non-EGFR Mutated Non-Small Cell Lung Cancer (NSCLC)

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.

NCT01504542 Non-small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

3 Interventions

Name: HS110 vaccine

Description: 0.5ml to be administered twice weekly for 18 weeks (36 doses)
Type: Biological
Group Labels: 1

Low-dose HS-110

Name: Placebo

Description: 0.5ml buffered saline placebo to be administered twice weekly for 18 weeks (36 doses)
Type: Biological
Group Labels: 1

Placebo vaccine + erlotinib 150mg orally once daily

Name: HS110 vaccine

Description: 0.5 mls to be dosed twice weekly for 18 weeks (36 doses)
Type: Biological
Group Labels: 1

High dose HS110


Primary Outcomes

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 18

Secondary Outcomes

Description: 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 year

Description: 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 22

Description: 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 18

Description: 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 18

Description: 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 18

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 L858R

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 ---



HPO Nodes


HPO: