drugset / Trial / NCT01504542

Immune Response and Safety of HS110 Vaccine in Combination With Erlotinib in Patients With Non-Small Cell Lung Cancer

NCT01504542

Phase 2 Withdrawn Heat Biologics
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2011-12
Primary completion
2013-12
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Viagenpumatucel-L Vaccine 2e+06 cells Intravenous
Subject Viagenpumatucel-L Vaccine 1e+07 cells Intravenous